Improving Maintenance Following Very Low Calorie Diet: The Sustain Lost Weight (SLW) Intervention
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Purpose
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 | Intervention |
|---|---|
|
Obesity |
Dietary Supplement: Optifast Products |
| Study Type: | Interventional |
| 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.
| Enrollment: | 30 |
| Study Start Date: | October 2010 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01222988
| United States, Florida | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| Principal Investigator: | Gretchen Ames, Ph.D. | Mayo Clinic |
More Information
| Responsible Party: | Gretchen E. Ames, Ph.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01222988 History of Changes |
| Other Study ID Numbers: | 10-002960 |
| Study First Received: | October 12, 2010 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on September 27, 2016