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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
  Purpose

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.


Condition Intervention
Obesity
Weight Loss
 Behavioral: Standard behavioral treatment
Behavioral: SBT + technology system (SBT+FIT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of a Traditional Behavioral Weight Loss Program Versus a Technology - Based Weight Loss Program in Severely Obese Individuals

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Change in body weight [ Time Frame: 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in physical activity [ Time Frame: 6-months ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: March 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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: 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.
 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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330329

Locations
United States, Rhode Island
Weight Control and Diabetes Research Center
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
Investigators
Principal Investigator: Rena Wing, PhD The Miriam Hospital
  More Information

No publications provided

Responsible Party: Jessica Unick, Assistant Professor (Research), The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01330329     History of Changes
Other Study ID Numbers: 0209-10
Study First Received: April 5, 2011
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Obesity
Weight loss
Exercise
Intervention studies

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 23, 2013