Comparison of Weight Loss Programs for Individuals With Severe Obesity

Not Applicable

Completed

• Conditions: Obesity; Weight Loss
• Interventions: Behavioral: SBT + technology system (SBT+FIT); Behavioral: Standard behavioral treatment

• Registration Number: NCT01330329
• Lead Sponsor: The Miriam Hospital

Brief Summary

The purpose of this study is to evaluate the effectiveness of a technology-based system (the Body Media FIT system) for enhancing weight loss in severely obese individuals (BMI: ≥ 40 kg/m2). The investigators will compare two 6-month interventions: 1) a standard behavioral weight loss program (SBT) and 2) a standard behavioral weight loss program plus the use of the Body Media FIT system (SBT+FIT). The Body Media® FIT system is a novel weight loss tool consisting of an armband that measures energy expenditure, a digital display watch that provides "real time" physical activity and energy expenditure feedback, and access to a system website which allows individuals to track their food intake and set exercise and dietary goals. We will examine differences in physical activity, weight loss, and program adherence between groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-05
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-18
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Age 21-55
• Body mass index (BMI) ≥40kg/m2 (or no more than 440 lbs)

Exclusion Criteria

• Recent weight loss (≥ 10 pounds within the past 6 months)
• Currently pregnant, pregnant within the last 6 months, or planning on becoming pregnant in the next 6 months.
• Presence of any condition that would limit exercise participation (assessed by the Physical Activity Readiness Questionnaire (PAR-Q)).
• A history of myocardial infarction or other heart-related surgeries.
• Currently enrolled in a commercial weight loss program.
• A recent (< 1 year) diagnosis or hospitalization for a psychological condition or history of psychosis (e.g. - Schizophrenia, Bipolar, Eating Disorder)
• Diagnosed with cancer within the past year or currently undergoing cancer treatment.
• Currently taking weight loss medications.
• Currently do not have daily access to a computer or Internet.
• Individuals with diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SBT + technology system (SBT+FIT)	SBT + technology system (SBT+FIT)	Participants will receive a standard behavioral weight loss program and will also be asked to use the Body Media FIT system as part of their weight loss intervention.
Standard behavioral treatment (SBT)	Standard behavioral treatment	Participants receive a standard behavioral weight loss program similar to that used in other large trials such as Look AHEAD and the Diabetes Prevention Program.

Primary Outcome Measures

Name	Time	Method
Change in body weight	6-months

Secondary Outcome Measures

Name	Time	Method
Change in physical activity	6-months

Trial Locations

Locations (1)

Weight Control and Diabetes Research Center; 🇺🇸 Providence, Rhode Island, United States