PROPEL: Promoting Successful Weight Loss in Primary Care in Louisiana

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02561221
• Collaborator: Louisiana State University Health Sciences Center Shreveport (Other), Tulane University (Other), Ochsner Health System (Other), Louisiana State University Health Sciences Center in New Orleans (Other), Xavier University of Louisiana. (Other), Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 803
• Location: 1
• Arms: 2
• Duration (Months): 41.2
• Patients Per Site Per Month: 19.5

Study Details

Study Description

Brief Summary

The primary aim of this trial is to develop and test the effectiveness of a 24 month, patient-centered, pragmatic and scalable obesity treatment program delivered within primary care, inclusive of an underserved population. Half of the clinics received a behavioral intervention delivered in a primary care setting and half of the clinics received usual care.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Lifestyle Counseling	N/A

Detailed Description

This study is a cluster-randomized, two-arm controlled trial in primary care settings. A total of 18 primary care clinics inclusive of low income populations with a high percentage of African Americans from urban and rural areas across Louisiana were randomized to either 1) intervention or 2) usual care. The sample includes 803 patients with obesity (BMI 30-50 kg/m2) (18 clinics, median of 40.5 patients / clinic). The primary aim of this trial is to develop and test the effectiveness of a 24 month, patient-centered, pragmatic and scalable obesity treatment program delivered within primary care, inclusive of an underserved population. Patients in the intervention arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the intervention arm received a series of webinars on obesity science to help them manage and treat obese patients. Patients assigned to the usual care arm will continue to interact with their Primary Care Practitioner according to their usual schedule, and will receive a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid Services (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure will be sent to the Primary Care Practitioners each year. Patients in both arms were assessed on primary and secondary outcome measures at baseline, and at 6, 12, 18 and 24 months of intervention.

Study Design

• Study Type: Interventional
• Actual Enrollment: 803 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Promoting Successful Weight Loss in Primary Care in Louisiana
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Sep 6, 2019
• Actual Study Completion Date: Sep 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lifestyle Counseling Patients in the Lifestyle Counseling Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity.	Behavioral: Lifestyle Counseling; Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.
No Intervention: Usual Care Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.

Outcome Measures

Primary Outcome Measures

1. Body Weight (Percent Change) [Percent (%) Change from Baseline to Month 24]

   Body weight is measured in light indoor clothes.

Secondary Outcome Measures

1. Waist Circumference [Change from Baseline to Month 24]

   Waist circumference is measured mid-way between the iliac crest and the lower rib margin.

2. Systolic Blood Pressure [Change from Baseline to Month 24]

   Resting systolic blood pressures is measured.

3. Fasting Plasma Glucose [Change from Baseline to Month 24]

   Glucose is measured in the fasted state with a point-of-care device.

4. Total Cholesterol [Change from Baseline to Month 24]

   Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.

5. Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function [Change from Baseline to Month 24]

   The PROMIS-29 physical function sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a better outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A positive change score indicates improvement while a negative change score indicates worsening from baseline.

6. PROMIS-29 Anxiety [Change from Baseline to Month 24]

   The PROMIS-29 Anxiety sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline.

7. PROMIS-29 Depression [Change from Baseline to Month 24]

   The PROMIS-29 Depression sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline.

8. PROMIS-29 Fatigue [Change from Baseline to Month 24]

   The PROMIS-29 Fatigue sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline.

9. PROMIS-29 Sleep Disturbance [Change from Baseline to Month 24]

   The PROMIS-29 sleep disturbance sub-scale includes 4 questions and scores ranges from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline.

10. PROMIS-29 Social Functioning [Change from Baseline to Month 24]

    The PROMIS-29 social roles sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a better outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A positive change score indicates improvement while a negative change score indicates worsening from baseline.

11. PROMIS-29 Pain Interference [Change from Baseline to Month 24]

    The PROMIS-29 pain interference sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline.

12. PROMIS-29 Pain Intensity [Change from Baseline to Month 24]

    The PROMIS-29 pain intensity sub-scale includes 1 question and scores range from 1 to 10 (higher values represent a worse outcome). A negative change score indicates improvement while a positive change score indicates worsening from baseline.

13. Impact of Weight on Quality of Life-Lite (IWQOL-L) Total Score [Change from Baseline to Month 24]

    Impact of Weight on Quality of Life-Lite (IWQOL-L) measure consists of a total score and five subscales--physical function, self-esteem, sexual life, public distress, and work. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The total transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline.

14. IWQOL-L Physical Function [Change from Baseline to Month 24]

    The IWQOL-L physical function sub-scale includes 11 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline.

15. IWQOL-L Self Esteem [Change from Baseline to Month 24]

    The IWQOL-L self-esteem sub-scale includes 7 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline.

16. IWQOL-L Sexual Life [Change from Baseline to Month 24]

    The IWQOL-L sexual life sub-scale includes 4 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline.

17. IWQOL-L Public Distress [Change from Baseline to Month 24]

    The IWQOL-L public distress sub-scale includes 5 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline.

18. IWQOL-L Work/Daily Activity [Change from Baseline to Month 24]

    The IWQOL-L work/daily activity sub-scale includes 4 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline.

19. Body Weight (Absolute Change) [Absolute (kg) Change from Baseline to Month 24]

    Body weight is measured in light indoor clothes.

20. Diastolic Blood Pressure [Change from Baseline to Month 24]

    Resting diastolic blood pressures is measured.

21. High-density Lipoprotein Cholesterol [Change from Baseline to Month 24]

    Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.

22. Low-density Lipoprotein Cholesterol [Change from Baseline to Month 24]

    Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.

23. Triglycerides [Change from Baseline to Month 24]

    Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 20.0 - 75.0 years

• BMI 30.0 - 50.0 kg/m2

• Able to provide written informed consent

• Willing to change diet, physical activity and weight

• Patient of a participating clinic

• Able to participate in scheduled sessions

Exclusion Criteria:

• Currently participating in a weight loss program

• Current use of weight loss medication or recent weight loss (>10 lbs in last 6 months)

• Plans to move from the area within 2 years

• Given birth within the past year, is currently pregnant or plans to become pregnant within 2 years

• Past bariatric surgery or plans for bariatric surgery within 2 years

• Current major depression

• History of suicidal behavior or diagnosed eating disorder (bulimia, anorexia)

• Hospitalization for mental disorder or substance abuse in the previous year

• Active cancer (except prostate, skin and thyroid if approved by physician)

• Serious arrhythmias or cardiomyopathy

• Severe congestive heart failure

• Stroke or heart attack in previous six months

• Chronic Inflammatory conditions, including but not limited to severe arthritis, lupus, or inflammatory bowel disease(i.e. Crohn's disease or ulcerative colitis)

• Disease that is life threatening or that can interfere with or be aggravated by exercise or weight loss

• Discretion of primary care physician or principal investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

• Pennington Biomedical Research Center
• Louisiana State University Health Sciences Center Shreveport
• Tulane University
• Ochsner Health System
• Louisiana State University Health Sciences Center in New Orleans
• Xavier University of Louisiana.
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Peter T Katzmarzyk, PhD, Pennington Biomedical Research Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 6, 2020

More Information

Publications

None provided.

• Responsible Party: Peter T. Katzmarzyk, Associate Executive Director for Population and Public Health Sciences, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT02561221
• Other Study ID Numbers: PBRC 2015-052; PCORI#OB-1402-10977
• First Posted: Sep 25, 2015
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Peter T. Katzmarzyk, Associate Executive Director for Population and Public Health Sciences, Pennington Biomedical Research Center: primary care; pragmatic trial; weight loss; overweight; diet; physical activity; PCORI
• Additional relevant MeSH terms: Weight Loss

Study Results

Participant Flow

Recruitment Details

Eighteen primary care clinics were randomized equally to either the Intensive Lifestyle Intervention or Usual Care. Patients received the intervention to which their clinic was assigned. Study enrollment occurred from April 2016 to September 2017. Patients completed a pre-screener and attended a screening visit which included the consent process and measurement to determine height and weight for BMI among other eligibility criteria. Patients were enrolled upon baseline visit completion.

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Lifestyle Counseling Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Period Title: Overall Study
STARTED	452	351
Month 6	386	340
Month 12	365	326
Month 18	357	316
COMPLETED	362	308
NOT COMPLETED	90	43

Baseline Characteristics

Arm/Group Title	Lifestyle Counseling	Usual Care	Total
Arm/Group Description	Patients in the Lifestyle Counseling Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual health care schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.	Total of all reporting groups
Overall Participants	452	351	803
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.8 (12.7)	50.1 (13.6)	49.4 (13.1)
Sex: Female, Male (Count of Participants)
Female	398 88.1%	280 79.8%	678 84.4%
Male	54 11.9%	71 20.2%	125 15.6%
Race/Ethnicity, Customized (Count of Participants)
African American	332 73.5%	208 59.3%	540 67.2%
White	95 21%	113 32.2%	208 25.9%
Other	25 5.5%	30 8.5%	55 6.8%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	37.3 (4.6)	37.2 (4.8)	37.2 (4.7)

Outcome Measures

1. Primary Outcome

Title	Body Weight (Percent Change)
Description	Body weight is measured in light indoor clothes.
Time Frame	Percent (%) Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [percent change]	-4.99	-0.48

2. Secondary Outcome

Title	Waist Circumference
Description	Waist circumference is measured mid-way between the iliac crest and the lower rib margin.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [cm]	-4.42	0.71

3. Secondary Outcome

Title	Systolic Blood Pressure
Description	Resting systolic blood pressures is measured.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [mmHg]	1.94	0.41

4. Secondary Outcome

Title	Fasting Plasma Glucose
Description	Glucose is measured in the fasted state with a point-of-care device.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [mg/dL]	-1.25	-0.33

5. Secondary Outcome

Title	Total Cholesterol
Description	Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [mg/dL]	4.64	-1.26

6. Secondary Outcome

Title	Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function
Description	The PROMIS-29 physical function sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a better outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A positive change score indicates improvement while a negative change score indicates worsening from baseline.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [score on a scale]	0.82	-0.39

7. Secondary Outcome

Title	PROMIS-29 Anxiety
Description	The PROMIS-29 Anxiety sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [score on a scale]	-0.92	-0.53

8. Secondary Outcome

Title	PROMIS-29 Depression
Description	The PROMIS-29 Depression sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [score on a scale]	-0.18	0.64

9. Secondary Outcome

Title	PROMIS-29 Fatigue
Description	The PROMIS-29 Fatigue sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [score on a scale]	-2.82	-1.03

10. Secondary Outcome

Title	PROMIS-29 Sleep Disturbance
Description	The PROMIS-29 sleep disturbance sub-scale includes 4 questions and scores ranges from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [score on a scale]	-1.25	-0.35

11. Secondary Outcome

Title	PROMIS-29 Social Functioning
Description	The PROMIS-29 social roles sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a better outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A positive change score indicates improvement while a negative change score indicates worsening from baseline.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [score on a scale]	1.57	0.15

12. Secondary Outcome

Title	PROMIS-29 Pain Interference
Description	The PROMIS-29 pain interference sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [score on a scale]	-1.06	0.21

13. Secondary Outcome

Title	PROMIS-29 Pain Intensity
Description	The PROMIS-29 pain intensity sub-scale includes 1 question and scores range from 1 to 10 (higher values represent a worse outcome). A negative change score indicates improvement while a positive change score indicates worsening from baseline.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [units on a scale]	-0.02	0.21

14. Secondary Outcome

Title	Impact of Weight on Quality of Life-Lite (IWQOL-L) Total Score
Description	Impact of Weight on Quality of Life-Lite (IWQOL-L) measure consists of a total score and five subscales--physical function, self-esteem, sexual life, public distress, and work. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The total transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [score on a scale]	11.02	4.36

15. Secondary Outcome

Title	IWQOL-L Physical Function
Description	The IWQOL-L physical function sub-scale includes 11 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [score on a scale]	12.31	4.11

16. Secondary Outcome

Title	IWQOL-L Self Esteem
Description	The IWQOL-L self-esteem sub-scale includes 7 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [score on a scale]	14.39	7.62

17. Secondary Outcome

Title	IWQOL-L Sexual Life
Description	The IWQOL-L sexual life sub-scale includes 4 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [score on a scale]	14.32	4.49

18. Secondary Outcome

Title	IWQOL-L Public Distress
Description	The IWQOL-L public distress sub-scale includes 5 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [score on a scale]	5.38	2.41

19. Secondary Outcome

Title	IWQOL-L Work/Daily Activity
Description	The IWQOL-L work/daily activity sub-scale includes 4 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [score on a scale]	5.48	1.47

20. Secondary Outcome

Title	Body Weight (Absolute Change)
Description	Body weight is measured in light indoor clothes.
Time Frame	Absolute (kg) Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [kg]	-5.43	-0.91

21. Secondary Outcome

Title	Diastolic Blood Pressure
Description	Resting diastolic blood pressures is measured.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [mmHg]	-0.61	-0.64

22. Secondary Outcome

Title	High-density Lipoprotein Cholesterol
Description	Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [mg/dL]	4.16	-0.44

23. Secondary Outcome

Title	Low-density Lipoprotein Cholesterol
Description	Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [mg/dL]	3.22	-0.17

24. Secondary Outcome

Title	Triglycerides
Description	Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.
Time Frame	Change from Baseline to Month 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lifestyle Counseling	Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.	Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
Measure Participants	452	351
Least Squares Mean (95% Confidence Interval) [mg/dL]	-11.23	-5.58

Adverse Events

Time Frame	24 months
Arm/Group Title	Lifestyle Counseling		Usual Care
Arm/Group Description	Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines.		Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year.
All Cause Mortality
	Lifestyle Counseling		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/452 (0.4%)		1/351 (0.3%)
Serious Adverse Events
	Lifestyle Counseling		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	48/452 (10.6%)		35/351 (10%)
Blood and lymphatic system disorders
Anemia	1/452 (0.2%)	1	0/351 (0%)	0
Low White Blood Cell Count	0/452 (0%)	0	1/351 (0.3%)	1
Pulmonary Embolism	1/452 (0.2%)	1	0/351 (0%)	0
Cardiac disorders
Atrial Fibrillation	1/452 (0.2%)	1	3/351 (0.9%)	3
Myocardial Infarction	2/452 (0.4%)	2	1/351 (0.3%)	1
Angina	1/452 (0.2%)	1	1/351 (0.3%)	1
Congestive Heart Failure	1/452 (0.2%)	2	0/351 (0%)	0
Bradycardia	0/452 (0%)	0	1/351 (0.3%)	1
Arrythmia	2/452 (0.4%)	2	0/351 (0%)	0
Endocrine disorders
Hypothyroidism	0/452 (0%)	0	1/351 (0.3%)	1
Gastrointestinal disorders
Diverticulitis	1/452 (0.2%)	1	0/351 (0%)	0
Gastroenteritis	0/452 (0%)	0	1/351 (0.3%)	1
Stomach Ulcers	1/452 (0.2%)	1	1/351 (0.3%)	1
General disorders
Vertigo/Dizziness	0/452 (0%)	0	1/351 (0.3%)	1
Severe Dehydration	1/452 (0.2%)	1	1/351 (0.3%)	1
Low Electrolytes/Minerals	1/452 (0.2%)	1	0/351 (0%)	0
Hepatobiliary disorders
Gallbladder Issues/Stones	1/452 (0.2%)	1	1/351 (0.3%)	1
Infections and infestations
Otorhinolaryngological Infection	0/452 (0%)	0	1/351 (0.3%)	1
Intestinal Infection	1/452 (0.2%)	1	0/351 (0%)	0
Kidney Infection	1/452 (0.2%)	1	0/351 (0%)	0
Respiratory System Infection	3/452 (0.7%)	4	2/351 (0.6%)	2
Injury, poisoning and procedural complications
Allergic Reaction	2/452 (0.4%)	2	2/351 (0.6%)	2
Broken Bone	1/452 (0.2%)	1	0/351 (0%)	0
Concussion Complications	1/452 (0.2%)	1	0/351 (0%)	0
Mid- or Post-Surgical Complication	3/452 (0.7%)	3	2/351 (0.6%)	2
Metabolism and nutrition disorders
Hyperglycemic Event	1/452 (0.2%)	1	1/351 (0.3%)	1
Hypoglycemic Event	2/452 (0.4%)	2	0/351 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm	3/452 (0.7%)	3	3/351 (0.9%)	3
Nervous system disorders
Grand Mal Seizure	0/452 (0%)	0	1/351 (0.3%)	1
Psychiatric disorders
Attempted Suicide	1/452 (0.2%)	1	1/351 (0.3%)	1
Renal and urinary disorders
Renal Failure	1/452 (0.2%)	1	0/351 (0%)	0
Reproductive system and breast disorders
Enlarged Uterus	1/452 (0.2%)	1	1/351 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
Asthma Attack	1/452 (0.2%)	1	0/351 (0%)	0
Interstitial Lung Disease	1/452 (0.2%)	1	0/351 (0%)	0
Chronic Obstructive Pulmonary Disease	0/452 (0%)	0	1/351 (0.3%)	1
Surgical and medical procedures
Hernia	1/452 (0.2%)	1	0/351 (0%)	0
Cholecystectomy	1/452 (0.2%)	1	1/351 (0.3%)	1
Penile Implant	1/452 (0.2%)	1	0/351 (0%)	0
Hysterectomy	5/452 (1.1%)	5	0/351 (0%)	0
Musculoskeletal Surgery	3/452 (0.7%)	3	2/351 (0.6%)	3
Preventive Brain Bypass Surgery	1/452 (0.2%)	1	0/351 (0%)	0
Gastric Sleeve	1/452 (0.2%)	1	0/351 (0%)	0
Cyst Removal	0/452 (0%)	0	2/351 (0.6%)	2
Preventive Mastectomy and Reconstruction	0/452 (0%)	0	1/351 (0.3%)	1
Thyroidectomy	0/452 (0%)	0	1/351 (0.3%)	1
Heller Myotomy	0/452 (0%)	0	1/351 (0.3%)	1
Vascular disorders
Occlusion	3/452 (0.7%)	3	1/351 (0.3%)	1
Hypertensive Event	4/452 (0.9%)	5	1/351 (0.3%)	1
Hypotensive Event	0/452 (0%)	0	1/351 (0.3%)	1
Stroke	2/452 (0.4%)	2	2/351 (0.6%)	2
Other (Not Including Serious) Adverse Events
	Lifestyle Counseling		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/452 (7.7%)		46/351 (13.1%)
Infections and infestations
Otorhinolaryngological Infection	20/452 (4.4%)	26	27/351 (7.7%)	35
Respiratory System Infection	15/452 (3.3%)	19	19/351 (5.4%)	23

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.