Improving Maintenance Following Very Low Calorie Diet: The Sustain Lost Weight (SLW) Intervention

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Optifast Products

• Registration Number: NCT01222988
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-15
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
very low calorie diet program	Optifast Products	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States