Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOptifast Products
Optional Optifast products offered once every other week X 6 months; then monthly.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed