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

Study Overview
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Brief Summary
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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.

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Optifast Products


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: very low calorie diet program<br> | Dietary Supplement: Optifast Products<br>* Optional Optifast products offered once every other week X 6 months; then monthly.<br>* Other names: Optifast Dietary Supplements;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Feasibility | 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. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Gain Analysis | 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. | 52 weeks |