Improving Maintenance Following Very Low Calorie Diet: The Sustain Lost Weight (SLW) Intervention

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT01222988
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

Obtain a preliminary assessment of the feasibility and acceptability of delivering the sustained lost weight (SLW) intervention in a real-world clinical setting for patients who have completed a 21-week very low calorie diet (VLCD).

Hypothesis: Intervention will be feasible to implement as evidenced by the ability to recruit and retain participants and acceptable to participants as evidenced by self-report of satisfaction with the program and adoption of weight maintenance behaviors.

Secondary Aim: Obtain a preliminary assessment of the effectiveness of the sustained lost weight (SLW) intervention for patients who have completed 21 weeks of a very low calorie diet (VLCD).

Hypothesis: Greater than 75% of participants who receive this novel approach, where maintenance behaviors are individualized based on resting metabolic rate and a physical activity factor, will regain greater or equal to 10 kg. at week 52 follow-up.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Dietary Supplement: Optifast Products	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: very low calorie diet program	Dietary Supplement: Optifast Products; Optional Optifast products offered once every other week X 6 months; then monthly.; Other Names: Optifast Dietary Supplements

Outcome Measures

Primary Outcome Measures

1. Treatment Feasibility [52 weeks]

   Treatment will be considered feasible if greater than 50 % of participants attend a minimum of 17 of 20 sessions. The treatment will be considered acceptable for further study if greater than 50% of participants rate the maintenance program with a mean score of 6 or higher.

Secondary Outcome Measures

1. Weight Gain Analysis [52 weeks]

   Weight regain from week 1 to 52 will be analyzed. Patients who discontinue the study or are lost to follow-up will be assumed to have gained more than 10 kg at 12 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Completed fast and transition period of the OPTIFAST® program

• Be able to participate fully in all aspects of the study

• Willing to refrain from participating in additional weight loss interventions for the duration of the study

• Willing to provide written informed consent.

Exclusion Criteria:

• Myocardial infarction within 6 months

• Unstable angina

• Stroke

• Chronic steroid use

• Active peptic ulcer disease

• Advanced cirrhosis

• Active hepatitis

• Advanced renal disease

• Active thrombophlebitis

• Recent skeletal fractures

• Use of lithium

• Pancreatitis

• Pregnancy

• Type 1 diabetes mellitus

• History of diabetic ketoacidosis

• Active bulimia nervosa

• Severe depression

• Psychosis

• Substance abuse

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Gretchen Ames, Ph.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01222988
• Other Study ID Numbers: 10-002960
• First Posted: Oct 18, 2010
• Last Update Posted: Jan 17, 2013
• Last Verified: Jan 1, 2013

Study Results

No Results Posted as of Jan 17, 2013