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Comparison of Weight Loss Programs for Individuals With Severe Obesity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jessica Unick, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01330329
First received: April 5, 2011
Last updated: April 18, 2012
Last verified: April 2012
History of Changes

April 5, 2011
April 18, 2012
March 2011
October 2011   (final data collection date for primary outcome measure)
Change in body weight [ Time Frame: 6-months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01330329 on ClinicalTrials.gov Archive Site
Change in physical activity [ Time Frame: 6-months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Weight Loss
  • Behavioral: 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. 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.
  • Behavioral: 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. 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.
  • Experimental: 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: Behavioral: SBT + technology system (SBT+FIT)
  • Experimental: 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: Behavioral: Standard behavioral treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
21 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01330329
0209-10
No
Jessica Unick, The Miriam Hospital
The Miriam Hospital
Not Provided
Principal Investigator: Rena Wing, PhD The Miriam Hospital
The Miriam Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP