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Clinical Trials/NCT01330329
NCT01330329
Completed
Not Applicable

Comparison of a Traditional Behavioral Weight Loss Program Versus a Technology - Based Weight Loss Program in Severely Obese Individuals

The Miriam Hospital1 site in 1 country29 target enrollmentMarch 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
The Miriam Hospital
Enrollment
29
Locations
1
Primary Endpoint
Change in body weight
Status
Completed
Last Updated
14 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
October 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jessica Unick

Assistant Professor (Research)

The Miriam Hospital

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

Outcomes

Primary Outcomes

Change in body weight

Time Frame: 6-months

Secondary Outcomes

  • Change in physical activity(6-months)

Study Sites (1)

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