Improving Maintenance Following Very Low Calorie Diet: The Sustain Lost Weight (SLW) Intervention
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
- Treatment Feasibility [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]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.
- Weight Gain Analysis [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
|very low calorie diet program||
Dietary Supplement: Optifast Products
Optional Optifast products offered once every other week X 6 months; then monthly.
Other Name: Optifast Dietary Supplements
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222988
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Gretchen Ames, Ph.D.||Mayo Clinic|