Retrospective Chart Review of the 5 & 2 & 2 and 4 & 2 & 1 Plans

• Sponsor: Medifast, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02150837
• Collaborator: (none)
• Enrollment: 372
• Location: 1
• Duration (Months): 3.9
• Patients Per Site Per Month: 94.4

Study Details

Study Description

Brief Summary

The purpose of this study is to retrospectively and systematically review records of overweight and obese Medifast Weight Control Center (MWCC) members who have been assigned to the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan for weight loss to gain a better understanding of the effectiveness of these programs. The study will describe demographics of this population, along with weight loss, anthropometrics, body composition and effects on available cardiovascular parameters. Adherence to the plans will also be examined.

The study hypothesis is that the 5 & 2 & 2 Meal Replacement Plan and the 4 & 2 & 1 Meal Replacement Plan are both effective programs for weight loss in overweight and obese adults.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: 5 & 2 & 2 Plan; Other: 4 & 2 & 1 Plan

Study Design

• Study Type: Observational
• Actual Enrollment: 372 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Retrospective Chart Review to Assess Weight Loss in Overweight and Obese Adults Using Either the 5 & 2 & 2 Meal Replacement Plan or the 4 & 2 & 1 Meal Replacement Plan at Medifast Weight Control Centers
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
5 & 2 & 2 Plan MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss.	Other: 5 & 2 & 2 Plan; Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.
4 & 2 & 1 Plan MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss.	Other: 4 & 2 & 1 Plan; Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.

Outcome Measures

Primary Outcome Measures

1. Body Weight [12 weeks]

   The primary endpoint in this study is weight and the primary outcome is change from baseline body weight at 12 weeks for each plan (5 & 2 & 2 and 4 & 2 & 1 Plans). Change from baseline will also be examined at other predetermined time points (e.g., 1, 2, 4, 8, 16, 20 and 24 weeks, and final weight loss visit - the mean length of time from baseline to the final weight loss visit was 18.06 weeks for the 5 & 2 & 2 Plan and 17.35 weeks for the 4 & 2 & 1 Plan.).

Secondary Outcome Measures

1. Percentage of Subjects Who Lose at Least 5% of Baseline Body Weight [12 weeks]

   The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

2. Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight [12 weeks]

   The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

3. Lean Mass [12 weeks]

   Lean mass expressed as an absolute change from baseline.

4. Fat Mass [12 weeks]

   Fat mass expressed as an absolute change from baseline.

5. Abdominal Circumference [12 weeks]

   Abdominal circumference expressed as an absolute change from baseline.

6. Waist Circumference [12 weeks]

   Waist circumference expressed as an absolute change from baseline.

7. Hip Circumference [12 weeks]

   Hip circumference expressed as an absolute change from baseline.

8. Blood Pressure [12 weeks]

   Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

9. Pulse [12 weeks]

   Pulse expressed as an absolute change from baseline.

10. Blood Pressure Categorical [12 weeks]

    Blood pressure expressed as a categorical variable (normotensive, pre-hypertensive and hypertensive based on National Institute of Health Guidelines) with the percent of participants that improved (e.g. from hypertensive to pre-hypertensive or normal) their blood pressure category from baseline to 12 weeks.

11. Resting Metabolic Rate [Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)]

    Resting metabolic rate expressed as an absolute change from baseline to final weight loss visit (The average length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).

12. Adherence [12 weeks]

    Adherence will be assessed through attendance at weekly visits and documented use of meal replacements at each visit. (Meal replacement adherence=average number of self-reported daily meal replacements through 12 weeks/nuber of prescribed meal replacements; Attendance adherence=number of visits/number of weeks on plan

13. Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight [1 weeks]

    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

14. Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight [2 weeks]

    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

15. Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight [4 weeks]

    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

16. Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight [8 weeks]

    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

17. Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight [16 weeks]

    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

18. Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight [20 weeks]

    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

19. Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight [24 weeks]

    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

20. Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight [Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)]

    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans) at their final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).

21. Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight [1 weeks]

    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

22. Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight [2 weeks]

    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

23. Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight [4 weeks]

    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

24. Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight [8 weeks]

    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

25. Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight [16 weeks]

    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

26. Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight [20 weeks]

    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

27. Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight [24 weeks]

    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

28. Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight [Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)]

    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans) at their final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).

29. Lean Mass [4 weeks]

    Lean mass expressed as an absolute change from baseline.

30. Lean Mass [8 weeks]

    Lean mass expressed as an absolute change from baseline.

31. Lean Mass [16 weeks]

    Lean mass expressed as an absolute change from baseline.

32. Lean Mass [20 weeks]

    Lean mass expressed as an absolute change from baseline.

33. Lean Mass [24 weeks]

    Lean mass expressed as an absolute change from baseline.

34. Fat Mass [4 weeks]

    Fat mass expressed as an absolute change from baseline.

35. Fat Mass [8 weeks]

    Fat mass expressed as an absolute change from baseline.

36. Fat Mass [16 weeks]

    Fat mass expressed as an absolute change from baseline.

37. Fat Mass [20 weeks]

    Fat mass expressed as an absolute change from baseline.

38. Abdominal Circumference [4 weeks]

    Abdominal circumference expressed as an absolute change from baseline.

39. Abdominal Circumference [8 weeks]

    Abdominal circumference expressed as an absolute change from baseline.

40. Abdominal Circumference [16 weeks]

    Abdominal circumference expressed as an absolute change from baseline.

41. Abdominal Circumference [20 weeks]

    Abdominal circumference expressed as an absolute change from baseline.

42. Abdominal Circumference [24 weeks]

    Abdominal circumference expressed as an absolute change from baseline.

43. Waist Circumference [4 weeks]

    Waist circumference expressed as an absolute from baseline.

44. Waist Circumference [8 weeks]

    Waist circumference expressed as an absolute change from baseline.

45. Waist Circumference [16 weeks]

    Waist circumference expressed as an absolute change from baseline.

46. Waist Circumference [20 weeks]

    Waist circumference expressed as an absolute change from baseline.

47. Waist Circumference [24 weeks]

    Waist circumference expressed as an absolute change from baseline.

48. Hip Circumference [4 weeks]

    Hip circumference expressed as an absolute change from baseline.

49. Hip Circumference [8 weeks]

    Hip circumference expressed as an absolute change from baseline.

50. Hip Circumference [16 weeks]

    Hip circumference expressed as an absolute change from baseline.

51. Hip Circumference [20 weeks]

    Hip circumference expressed as an absolute change from baseline.

52. Hip Circumference [24 weeks]

    Hip circumference expressed as an absolute change from baseline.

53. Blood Pressure [1 weeks]

    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

54. Blood Pressure [2 weeks]

    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

55. Blood Pressure [4 weeks]

    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

56. Blood Pressure [8 weeks]

    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

57. Blood Pressure [16 weeks]

    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

58. Blood Pressure [20 weeks]

    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

59. Blood Pressure [24 weeks]

    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

60. Blood Pressure [Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)]

    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline to final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).

61. Pulse [1 weeks]

    Pulse expressed as an absolute change from baseline.

62. Pulse [2 weeks]

    Pulse expressed as an absolute change from baseline.

63. Pulse [4 weeks]

    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

64. Pulse [8 weeks]

    Pulse expressed as an absolute change from baseline.

65. Pulse [16 weeks]

    Pulse expressed as an absolute change from baseline.

66. Pulse [20 weeks]

    Pulse expressed as an absolute change from baseline.

67. Pulse [24 weeks]

    Pulse expressed as an absolute change from baseline.

68. Pulse [Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)]

    Pulse expressed as an absolute change from baseline to final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).

69. Adherence [4 weeks]

    Adherence will be assessed through documented use of meal replacements at each visit.

70. Adherence [8 weeks]

    Adherence will be assessed through documented use of meal replacements at each visit.

71. Adherence [16 weeks]

    Adherence will be assessed through documented use of meal replacements at each visit.

72. Adherence [20 weeks]

    Adherence will be assessed through documented use of meal replacements at each visit.

73. Adherence [24 weeks]

    Adherence will be assessed through documented use of meal replacements at each visit.

74. Adherence [Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)]

    Adherence will be assessed through documented use of meal replacements at each visit from baseline (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).

75. Body Weight [1 week]

    Change in body weight from baseline reported as absolute change.

76. Body Weight [2 weeks]

    Change in body weight from baseline reported as absolute change from baseline.

77. Body Weight [4 weeks]

    Change in body weight from baseline reported absolute change from baseline.

78. Body Weight [8 weeks]

    Change in body weight from baseline reported as absolute change.

79. Body Weight [16 weeks]

    Change in body weight from baseline reported as absolute change.

80. Body Weight [20 weeks]

    Change in body weight from baseline reported as absolute change.

81. Body Weight [Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)]

    Change in body weight from baseline to final weight loss visit reported as absolute change. (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.)

82. Fat Mass [24 weeks]

    Fat mass expressed as an absolute change from baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult males and females, 18 years of age or older at the start of the weight loss program.

• Subject has a BMI ≥ 25 kg/m2.

• Subject started a weight management program at the MWCC location on or after January 1, 2012.

• Subject followed the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan for at least the first two weeks of their weight loss phase while an active member of the MWCC.

• Subject signed the Personal Health Information Consent Form.

Exclusion Criteria:

• Subject was concurrently following another weight loss program other than the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan while on that respective plan.

• Subject had documented use of prescription or over-the-counter weight loss pharmacotherapy (e.g., phentermine, Orlistat) concurrently with the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan.

• Subject completed initial consultation but did not participate in any follow-up visits.

• Subject is currently in the active weight loss phase of their program at the MWCC (Subjects in the transition or weight maintenance phases of their programs are eligible.)

• Written request by subject to revoke consent to use health information is present in subject chart.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medifast, Inc.	Owings Mills	Maryland	United States	21117

Sponsors and Collaborators

• Medifast, Inc.

Investigators

• Principal Investigator: Linda M Aterburn, PhD, Medifast, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medifast, Inc.
• ClinicalTrials.gov Identifier: NCT02150837
• Other Study ID Numbers: MED 017
• First Posted: May 30, 2014
• Last Update Posted: Sep 13, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by Medifast, Inc.: Obesity; Weight Loss; Meal replacements; Weight maintenance
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Recruitment Details	This is a retrospective chart review of Medifast Weight Control Center (MWCC) clients from 21 centers that used either the Medifast 5 & 2 & 2 Plan or 4 & 2 & 1 Plan for weight loss between 1/2012 and 3/2014 - it is retropsective and observational in nature, so there was no recruitment involved. The plans were evaluated separately and not compared.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Period Title: Overall Study
STARTED	62	310
COMPLETED	37	185
NOT COMPLETED	25	125

Baseline Characteristics

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan	Total
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.	Total of all reporting groups
Overall Participants	62	310	372
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	55 88.7%	222 71.6%	277 74.5%
>=65 years	7 11.3%	88 28.4%	95 25.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.8 (13.7)	53.5 (14.7)	52.4 (14.8)
Sex: Female, Male (Count of Participants)
Female	27 43.5%	177 57.1%	204 54.8%
Male	35 56.5%	133 42.9%	168 45.2%
Region of Enrollment (participants) [Number]
United States	62 100%	310 100%	372 100%
Weight (Pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Pounds]	327.11 (64.33)	240.00 (47.83)	254.02 (60.25)
BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	48.7 (9.9)	37.7 (6.8)	39.5 (8.5)
Lean Body Mass (Pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Pounds]	168.52 (31.46)	135.96 (31.24)	140.33 (33.09)
Body Fat Mass (Pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Pounds]	152.46 (41.36)	103.40 (30.58)	110.04 (36.41)

Outcome Measures

1. Primary Outcome

Title	Body Weight
Description	The primary endpoint in this study is weight and the primary outcome is change from baseline body weight at 12 weeks for each plan (5 & 2 & 2 and 4 & 2 & 1 Plans). Change from baseline will also be examined at other predetermined time points (e.g., 1, 2, 4, 8, 16, 20 and 24 weeks, and final weight loss visit - the mean length of time from baseline to the final weight loss visit was 18.06 weeks for the 5 & 2 & 2 Plan and 17.35 weeks for the 4 & 2 & 1 Plan.).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	37	185
Mean (Standard Deviation) [Pounds]	-28.35 (15.60)	-23.95 (12.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	5 & 2 & 2 Plan, 4 & 2 & 1 Plan
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments	Within group comparison (for each group) using a non-parametric paired Wilcoxon signed rank test comparing repeated measures in a single sample.

2. Secondary Outcome

Title	Percentage of Subjects Who Lose at Least 5% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	37	185
Number [percentage of subjects]	75.7	85.4

3. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	37	185
Number [percentage of subjects]	40.5	50.8

4. Secondary Outcome

Title	Lean Mass
Description	Lean mass expressed as an absolute change from baseline.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects remaining at 12 weeks had body composition testing performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	12	86
Mean (Standard Deviation) [Pounds]	-5.47 (6.41)	-5.31 (4.89)

5. Secondary Outcome

Title	Fat Mass
Description	Fat mass expressed as an absolute change from baseline.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects remaining at 12 weeks had body composition testing performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	12	86
Mean (Standard Deviation) [Pounds]	-21.09 (8.09)	-21.25 (10.90)

6. Secondary Outcome

Title	Abdominal Circumference
Description	Abdominal circumference expressed as an absolute change from baseline.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects remaining at 12 weeks had measurement performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	10	73
Mean (Standard Deviation) [Inches]	-3.70 (1.30)	-4.47 (2.59)

7. Secondary Outcome

Title	Waist Circumference
Description	Waist circumference expressed as an absolute change from baseline.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects remaining at 12 weeks had measurement performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	10	73
Mean (Standard Deviation) [Inches]	-3.55 (1.83)	-3.87 (2.34)

8. Secondary Outcome

Title	Hip Circumference
Description	Hip circumference expressed as an absolute change from baseline.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects remaining at 12 weeks had measurement performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	10	73
Mean (Standard Deviation) [Inches]	-4.18 (2.96)	-3.41 (2.22)

9. Secondary Outcome

Title	Blood Pressure
Description	Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects were remaining at 12 weeks and not all had measurement performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	13	114
Systolic	-17.69 (17.61)	-11.27 (16.65)
Diastolic	-8.38 (8.01)	-6.60 (12.62)

10. Secondary Outcome

Title	Pulse
Description	Pulse expressed as an absolute change from baseline.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects were remaining at 12 weeks and not all had measurement performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	13	111
Mean (Standard Deviation) [Beats per minute]	-3.62 (10.04)	-2.95 (10.48)

11. Secondary Outcome

Title	Blood Pressure Categorical
Description	Blood pressure expressed as a categorical variable (normotensive, pre-hypertensive and hypertensive based on National Institute of Health Guidelines) with the percent of participants that improved (e.g. from hypertensive to pre-hypertensive or normal) their blood pressure category from baseline to 12 weeks.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects were remaining at 12 weeks and not all had measurement performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	13	114
Number [Percent of participants]	53.8 86.8%	49.1 15.8%

12. Secondary Outcome

Title	Resting Metabolic Rate
Description	Resting metabolic rate expressed as an absolute change from baseline to final weight loss visit (The average length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).
Time Frame	Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)

Outcome Measure Data

Analysis Population Description

Number of participants with paired data at baseline and final weight loss visit was too small for meaningful analysis.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	1	6
Mean (Standard Deviation) [calories]	10 (0)	-216.67 (279.48)

13. Secondary Outcome

Title	Adherence
Description	Adherence will be assessed through attendance at weekly visits and documented use of meal replacements at each visit. (Meal replacement adherence=average number of self-reported daily meal replacements through 12 weeks/nuber of prescribed meal replacements; Attendance adherence=number of visits/number of weeks on plan
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	62	310
Meal replacement compliance	83.85 (16.67)	88.79 (18.64)
Attendance compliance	83.65 (19.09)	85.71 (17.94)

14. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	1 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	54	283
Number [Percent of subjects]	1.6	3.2

15. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	56	280
Number [Percent of subjects]	8.9	16.1

16. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	57	289
Number [Percent of subjects]	33.3	50.2

17. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	48	239
Number [Percent of subjects]	72.9	76.2

18. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	24	151
Number [Percent of subjects]	95.8	92.7

19. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	23	112
Number [Percent of subjects]	95.7	94.6

20. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	17	81
Number [Percent of subjects]	88.2	96.3

21. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans) at their final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).
Time Frame	Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	62	306
Number [Percent of subjects]	62.9	69.6

22. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	1 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	54	283
Number [Percent of subjects]	0.0	0.0

23. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	56	280
Number [Percent of subjects]	0.0	0.0

24. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	57	289
Number [Percent of subjects]	0.0	1.0

25. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	48	239
Number [Percent of subjects]	16.7	23.0

26. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	24	151
Number [Percent of subjects]	50.0	64.9

27. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	23	112
Number [Percent of subjects]	56.5	69.6

28. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	17	81
Number [Percent of subjects]	58.8	75.3

29. Secondary Outcome

Title	Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight
Description	The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans) at their final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).
Time Frame	Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	62	306
Number [Percent of subjects]	29.0	39.9

30. Secondary Outcome

Title	Lean Mass
Description	Lean mass expressed as an absolute change from baseline.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	26	177
Mean (Standard Deviation) [Pounds]	-5.19 (5.42)	-4.50 (4.66)

31. Secondary Outcome

Title	Lean Mass
Description	Lean mass expressed as an absolute change from baseline.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	11	96
Mean (Standard Deviation) [Pounds]	-8.36 (5.67)	-4.49 (5.36)

32. Secondary Outcome

Title	Lean Mass
Description	Lean mass expressed as an absolute change from baseline.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	8	55
Mean (Standard Deviation) [Pounds]	-11.15 (4.62)	-4.29 (6.45)

33. Secondary Outcome

Title	Lean Mass
Description	Lean mass expressed as an absolute change from baseline.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	6	44
Mean (Standard Deviation) [Pounds]	-13.83 (5.33)	-5.08 (6.96)

34. Secondary Outcome

Title	Lean Mass
Description	Lean mass expressed as an absolute change from baseline.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects were remaining at 24 weeks and not all had measurement performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	3	55
Mean (Standard Deviation) [Pounds]	-14.35 (9.14)	-6.79 (6.45)

35. Secondary Outcome

Title	Fat Mass
Description	Fat mass expressed as an absolute change from baseline.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	26	177
Mean (Standard Deviation) [Pounds]	-11.46 (6.92)	-9.09 (7.71)

36. Secondary Outcome

Title	Fat Mass
Description	Fat mass expressed as an absolute change from baseline.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	11	106
Mean (Standard Deviation) [Pounds]	-17.35 (5.80)	-16.27 (8.16)

37. Secondary Outcome

Title	Fat Mass
Description	Fat mass expressed as an absolute change from baseline.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	8	70
Mean (Standard Deviation) [Pounds]	-26.38 (9.11)	-26.34 (12.16)

38. Secondary Outcome

Title	Fat Mass
Description	Fat mass expressed as an absolute change from baseline.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	6	53
Mean (Standard Deviation) [Pounds]	-34.03 (11.64)	-29.03 (17.00)

39. Secondary Outcome

Title	Abdominal Circumference
Description	Abdominal circumference expressed as an absolute change from baseline.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	27	158
Mean (Standard Deviation) [Inches]	-2.81 (2.08)	-1.86 (1.71)

40. Secondary Outcome

Title	Abdominal Circumference
Description	Abdominal circumference expressed as an absolute change from baseline.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	16	86
Mean (Standard Deviation) [Inches]	-4.42 (3.04)	-3.28 (1.99)

41. Secondary Outcome

Title	Abdominal Circumference
Description	Abdominal circumference expressed as an absolute change from baseline.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	6	63
Mean (Standard Deviation) [Inches]	-5.71 (1.19)	-4.46 (2.73)

42. Secondary Outcome

Title	Abdominal Circumference
Description	Abdominal circumference expressed as an absolute change from baseline.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	7	41
Mean (Standard Deviation) [Inches]	-6.25 (1.89)	-5.78 (3.06)

43. Secondary Outcome

Title	Abdominal Circumference
Description	Abdominal circumference expressed as an absolute change from baseline.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	3	24
Mean (Standard Deviation) [Inches]	-4.83 (5.16)	-5.98 (2.74)

44. Secondary Outcome

Title	Waist Circumference
Description	Waist circumference expressed as an absolute from baseline.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	27	158
Mean (Standard Deviation) [Inches]	-2.21 (1.49)	-1.97 (1.37)

45. Secondary Outcome

Title	Waist Circumference
Description	Waist circumference expressed as an absolute change from baseline.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	16	86
Mean (Standard Deviation) [Inches]	-3.60 (2.42)	-3.24 (1.72)

46. Secondary Outcome

Title	Waist Circumference
Description	Waist circumference expressed as an absolute change from baseline.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	6	63
Mean (Standard Deviation) [Inches]	-4.38 (2.06)	-4.75 (2.22)

47. Secondary Outcome

Title	Waist Circumference
Description	Waist circumference expressed as an absolute change from baseline.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	7	41
Mean (Standard Deviation) [Inches]	-6.93 (2.49)	-5.32 (2.70)

48. Secondary Outcome

Title	Waist Circumference
Description	Waist circumference expressed as an absolute change from baseline.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	3	24
Mean (Standard Deviation) [Inches]	-3.92 (3.89)	-5.35 (2.88)

49. Secondary Outcome

Title	Hip Circumference
Description	Hip circumference expressed as an absolute change from baseline.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	27	158
Mean (Standard Deviation) [Inches]	-2.40 (1.88)	-1.56 (1.36)

50. Secondary Outcome

Title	Hip Circumference
Description	Hip circumference expressed as an absolute change from baseline.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	14	86
Mean (Standard Deviation) [Inches]	-3.34 (1.99)	-2.68 (1.64)

51. Secondary Outcome

Title	Hip Circumference
Description	Hip circumference expressed as an absolute change from baseline.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	6	63
Mean (Standard Deviation) [Inches]	-4.42 (3.02)	-3.97 (2.15)

52. Secondary Outcome

Title	Hip Circumference
Description	Hip circumference expressed as an absolute change from baseline.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	6	41
Mean (Standard Deviation) [Inches]	-5.38 (1.90)	-5.38 (3.96)

53. Secondary Outcome

Title	Hip Circumference
Description	Hip circumference expressed as an absolute change from baseline.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	3	24
Mean (Standard Deviation) [Inches]	-5.17 (3.33)	-4.92 (2.68)

54. Secondary Outcome

Title	Blood Pressure
Description	Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time Frame	1 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	24	165
Systolic	-4.63 (17.17)	-5.80 (14.05)
Diastolic	-2.63 (10.49)	-3.59 (9.98)

55. Secondary Outcome

Title	Blood Pressure
Description	Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects were remaining at 2 weeks and not all had measurement performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	22	174
Systolic	-6.41 (15.63)	-8.53 (13.97)
Diastolic	-2.91 (9.89)	-5.37 (10.84)

56. Secondary Outcome

Title	Blood Pressure
Description	Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects were remaining at 4 weeks and not all had measurement performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	26	175
Systolic	-7.81 (19.76)	-9.87 (16.93)
Diastolic	-7.31 (9.00)	-5.90 (12.13)

57. Secondary Outcome

Title	Blood Pressure
Description	Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects were remaining at 8 weeks and not all had measurement performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	24	144
Systolic	-14.21 (26.06)	-7.51 (14.68)
Diastolic	-9.25 (11.30)	-6.11 (11.09)

58. Secondary Outcome

Title	Blood Pressure
Description	Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects were remaining at 16 weeks and not all had measurement performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	11	95
Systolic	-19.27 (25.09)	-10.59 (17.03)
Diastolic	-8.55 (11.60)	-6.84 (9.94)

59. Secondary Outcome

Title	Blood Pressure
Description	Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects were remaining at 20 weeks and not all had measurement performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	11	70
Systolic	-21.55 (20.62)	-9.34 (17.49)
Diastolic	-8.55 (11.12)	-6.26 (13.05)

60. Secondary Outcome

Title	Blood Pressure
Description	Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects were remaining at 24 weeks and not all had measurement performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	9	52
Systolic	-14.33 (16.19)	-7.79 (19.40)
Diastolic	-5.44 (8.41)	-3.92 (14.18)

61. Secondary Outcome

Title	Blood Pressure
Description	Blood pressure (systolic and diastolic) expressed as an absolute change from baseline to final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).
Time Frame	Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)

Outcome Measure Data

Analysis Population Description

Not all subjects had measurement performed at their final visit.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	24	163
Systolic	-16.96 (21.79)	-9.52 (15.62)
Diastolic	-7.08 (10.68)	-5.64 (11.58)

62. Secondary Outcome

Title	Pulse
Description	Pulse expressed as an absolute change from baseline.
Time Frame	1 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	24	162
Mean (Standard Deviation) [Beats per minute]	-0.46 (12.86)	1.07 (9.42)

63. Secondary Outcome

Title	Pulse
Description	Pulse expressed as an absolute change from baseline.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	22	173
Mean (Standard Deviation) [mmHg]	-3.27 (10.27)	-1.21 (9.94)

64. Secondary Outcome

Title	Pulse
Description	Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	26	175
Mean (Standard Deviation) [Beats per minute]	-1.62 (12.52)	-2.88 (10.11)

65. Secondary Outcome

Title	Pulse
Description	Pulse expressed as an absolute change from baseline.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	24	142
Mean (Standard Deviation) [Beats per minute]	-1.17 (17.84)	-2.65 (10.71)

66. Secondary Outcome

Title	Pulse
Description	Pulse expressed as an absolute change from baseline.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	11	95
Mean (Standard Deviation) [Beats per minute]	-3.27 (11.29)	-3.73 (11.89)

67. Secondary Outcome

Title	Pulse
Description	Pulse expressed as an absolute change from baseline.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	11	71
Mean (Standard Deviation) [Beats per minute]	0.27 (13.27)	-2.31 (11.78)

68. Secondary Outcome

Title	Pulse
Description	Pulse expressed as an absolute change from baseline.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	9	51
Mean (Standard Deviation) [Beats per minute]	0.00 (4.66)	-3.67 (9.34)

69. Secondary Outcome

Title	Pulse
Description	Pulse expressed as an absolute change from baseline to final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).
Time Frame	Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	24	161
Mean (Standard Deviation) [Beats per minute]	-2.29 (10.75)	-2.29 (11.63)

70. Secondary Outcome

Title	Adherence
Description	Adherence will be assessed through documented use of meal replacements at each visit.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	53	276
Mean (Standard Deviation) [Percent compliance meal replacements]	94.53 (13.09)	96.29 (14.45)

71. Secondary Outcome

Title	Adherence
Description	Adherence will be assessed through documented use of meal replacements at each visit.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	47	225
Mean (Standard Deviation) [Percent compliance meal replacements]	88.3 (20.99)	95.17 (14.97)

72. Secondary Outcome

Title	Adherence
Description	Adherence will be assessed through documented use of meal replacements at each visit.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	21	145
Mean (Standard Deviation) [Percent compliance meal replacements]	79.52 (26.55)	94.29 (17.19)

73. Secondary Outcome

Title	Adherence
Description	Adherence will be assessed through documented use of meal replacements at each visit.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	20	107
Mean (Standard Deviation) [Percent compliance meal replacements]	89.00 (18.04)	89.25 (26.79)

74. Secondary Outcome

Title	Adherence
Description	Adherence will be assessed through documented use of meal replacements at each visit.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	15	74
Mean (Standard Deviation) [Percent compliance meal replacements]	90.67 (14.86)	91.22 (23.47)

75. Secondary Outcome

Title	Adherence
Description	Adherence will be assessed through documented use of meal replacements at each visit from baseline (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).
Time Frame	Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	58	273
Mean (Standard Deviation) [Percent compliance meal replacements]	82.41 (27.49)	85.26 (29.43)

76. Secondary Outcome

Title	Body Weight
Description	Change in body weight from baseline reported as absolute change.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	54	283
Mean (Standard Deviation) [Pounds]	-7.64 (4.86)	-5.95 (3.33)

77. Secondary Outcome

Title	Body Weight
Description	Change in body weight from baseline reported as absolute change from baseline.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	56	280
Mean (Standard Deviation) [Pounds]	-9.71 (4.95)	-8.24 (4.27)

78. Secondary Outcome

Title	Body Weight
Description	Change in body weight from baseline reported absolute change from baseline.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	57	289
Mean (Standard Deviation) [Pounds]	-14.26 (6.88)	-12.25 (6.01)

79. Secondary Outcome

Title	Body Weight
Description	Change in body weight from baseline reported as absolute change.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	48	239
Mean (Standard Deviation) [Pound]	-22.81 (11.21)	-18.32 (9.21)

80. Secondary Outcome

Title	Body Weight
Description	Change in body weight from baseline reported as absolute change.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	24	151
Mean (Standard Deviation) [Pounds]	-36.89 (16.45)	-28.84 (14.48)

81. Secondary Outcome

Title	Body Weight
Description	Change in body weight from baseline reported as absolute change.
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	23	112
Mean (Standard Deviation) [Pounds]	-40.51 (19.08)	-32.42 (16.22)

82. Secondary Outcome

Title	Body Weight
Description	Change in body weight from baseline to final weight loss visit reported as absolute change. (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.)
Time Frame	Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	62	306
Mean (Standard Deviation) [Pounds]	-29.25 (27.65)	-23.34 (18.65)

83. Secondary Outcome

Title	Fat Mass
Description	Fat mass expressed as an absolute change from baseline.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects remaining at 24 weeks had body composition testing performed.

Arm/Group Title	5 & 2 & 2 Plan	4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.	MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
Measure Participants	4	35
Mean (Standard Deviation) [Pounds]	-56.88 (18.52)	-32.00 (15.76)

Adverse Events

Time Frame	Charts from MWCC customers that followed either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan and met inclusion criteria who started their weight loss plan on or after January 1, 2012 and completed the active weight loss phase of their plan by March 31, 2014 (a total period of 2 years and 3 months).
Adverse Event Reporting Description	This is a retrospective chart review study, and all of the signs, symptoms, and incidents reported were lay accounts by MWCC staff during the routine visits that were included as a part of customers' weight loss programs - not specifically as part of a clinical trial. Therefore, information normally associated with adverse events (relatedness, seriousness, etc.) was not collected. This description pertains to all events (all-cause mortality, serious adverse events, and other adverse events.
Arm/Group Title	5 & 2 & 2 Plan		4 & 2 & 1 Plan
Arm/Group Description	MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss. 5 & 2 & 2 Plan: Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.		MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss. 4 & 2 & 1 Plan: Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
All Cause Mortality
	5 & 2 & 2 Plan		4 & 2 & 1 Plan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/62 (0%)		0/310 (0%)
Serious Adverse Events
	5 & 2 & 2 Plan		4 & 2 & 1 Plan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/62 (3.2%)		9/310 (2.9%)
Cardiac disorders
Heart attack	0/62 (0%)	0	1/310 (0.3%)	1
General disorders
Hospitalization	0/62 (0%)	0	2/310 (0.6%)	2
Infections and infestations
Fever	0/62 (0%)	0	1/310 (0.3%)	1
Surgical and medical procedures
cholecystectomy	1/62 (1.6%)	1	2/310 (0.6%)	2
Ruptured hemorrhoid	0/62 (0%)	0	1/310 (0.3%)	1
Vascular disorders
Stroke	0/62 (0%)	0	1/310 (0.3%)	1
Bloot clot	0/62 (0%)	0	1/310 (0.3%)	1
Mini-stroke	1/62 (1.6%)	1	0/310 (0%)	0
Other (Not Including Serious) Adverse Events
	5 & 2 & 2 Plan		4 & 2 & 1 Plan
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	46/62 (74.2%)		219/310 (70.6%)
Gastrointestinal disorders
constipation	9/62 (14.5%)	9	33/310 (10.6%)	33
gas/bloating	1/62 (1.6%)	1	22/310 (7.1%)	22
General disorders
hunger	12/62 (19.4%)	12	56/310 (18.1%)	56
fatigue	3/62 (4.8%)	3	34/310 (11%)	34
stress/anxiety	5/62 (8.1%)	5	16/310 (5.2%)	16
Sick Not Otherwise Specified	13/62 (21%)	13	69/310 (22.3%)	69
cravings	5/62 (8.1%)	5	14/310 (4.5%)	14
Headache	6/62 (9.7%)	6	12/310 (3.9%)	12

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.