Comparison of Weight Loss Programs for Individuals With Severe Obesity

Completed · Not applicable

Conditions studied: Obesity, Weight Loss

In brief

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.

Key facts

Study ID

NCT01330329

Run by

The Miriam Hospital

People needed

29

Starts

2011-03-01

Expected to finish

2011-10-01

Last updated by the study team

2012-04-20

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Weight Control and Diabetes Research Center — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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