Improving Maintenance Following Very Low Calorie Diet: The Sustain Lost Weight (SLW) Intervention
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 12, 2010
CompletedFirst Posted
Study publicly available on registry
October 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJanuary 17, 2013
January 1, 2013
2 years
October 12, 2010
January 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Weight Gain Analysis
52 weeks
Study Arms (1)
very low calorie diet program
OTHERInterventions
Optional Optifast products offered once every other week X 6 months; then monthly.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Jacksonville, Florida, 32224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gretchen Ames, Ph.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 12, 2010
First Posted
October 18, 2010
Study Start
October 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
January 17, 2013
Record last verified: 2013-01