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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optifast Products

Dietary Supplement

Optional Optifast products offered once every other week X 6 months; then monthly.

Other names: Optifast Dietary Supplements

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Oct 18, 2010
Registry last updated: Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed