Comparison of Weight Loss Programs for Individuals With Severe Obesity
Comparison of a Traditional Behavioral Weight Loss Program Versus a Technology - Based Weight Loss Program in Severely Obese Individuals
1 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Mar 2011
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 5, 2011
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedApril 20, 2012
April 1, 2012
7 months
April 5, 2011
April 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in body weight
6-months
Secondary Outcomes (1)
Change in physical activity
6-months
Study Arms (2)
SBT + technology system (SBT+FIT)
EXPERIMENTALParticipants 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)
EXPERIMENTALParticipants receive a standard behavioral weight loss program similar to that used in other large trials such as Look AHEAD and the Diabetes Prevention Program.
Interventions
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. Individuals will come to weekly group meetings for 6-months and will be instructed to reduce caloric intake, increase physical activity, and self-monitor their weight, eating, and exercise behaviors.
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. Individuals will come to weekly group meetings for 6-months and will be instructed to reduce caloric intake, increase physical activity, and self-monitor their weight, eating, and exercise behaviors. Participants in this group will also wear an armband that measures energy expenditure and they will log their food intake on the internet.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903, United States
Related Publications (1)
Unick JL, O'Leary KC, Dorfman L, Thomas JG, Strohacker K, Wing RR. Consistency in compensatory eating responses following acute exercise in inactive, overweight and obese women. Br J Nutr. 2015 Apr 14;113(7):1170-7. doi: 10.1017/S000711451500046X. Epub 2015 Mar 17.
PMID: 25778833DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rena Wing, PhD
The Miriam Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor (Research)
Study Record Dates
First Submitted
April 5, 2011
First Posted
April 6, 2011
Study Start
March 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
April 20, 2012
Record last verified: 2012-04