Improving Maintenance Following Very Low Calorie Diet: The Sustain Lost Weight (SLW) Intervention
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|ClinicalTrials.gov Identifier: NCT01222988|
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : January 17, 2013
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
|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
- Treatment Feasibility [ Time Frame: 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.
- Weight Gain Analysis [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01222988
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Gretchen Ames, Ph.D.||Mayo Clinic|