Comparison of a Traditional Behavioral Weight Loss Program Versus a Technology - Based Weight Loss Program in Severely Obese Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Miriam Hospital
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Change in body weight
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: SBT + technology system (SBT+FIT) (Behavioral)
Standard behavioral treatment (SBT)
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.
Intervention: Standard behavioral treatment (Behavioral)
Outcomes
Primary Outcomes
Change in body weight
Time Frame: 6-months
Secondary Outcomes
- Change in physical activity(6-months)
Investigators
Jessica Unick
Assistant Professor (Research)
The Miriam Hospital