Back to resultsComparison of Weight Loss Programs for Individuals With Severe Obesity
Primary Purpose
Obesity, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard behavioral treatment
SBT + technology system (SBT+FIT)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight loss, Exercise, Intervention studies
Eligibility Criteria
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
Sites / Locations
- Weight Control and Diabetes Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SBT + technology system (SBT+FIT)
Standard behavioral treatment (SBT)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in body weight
Secondary Outcome Measures
Change in physical activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01330329
Brief Title
Comparison of Weight Loss Programs for Individuals With Severe Obesity
Official Title
Comparison of a Traditional Behavioral Weight Loss Program Versus a Technology - Based Weight Loss Program in Severely Obese Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Obesity, Weight loss, Exercise, Intervention studies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SBT + technology system (SBT+FIT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard behavioral treatment (SBT)
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Standard behavioral treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SBT + technology system (SBT+FIT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body weight
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Change in physical activity
Time Frame
6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rena Wing, PhD
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weight Control and Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25778833
Citation
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.
Results Reference
derived
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Comparison of Weight Loss Programs for Individuals With Severe Obesity
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