Comparison of Weight Loss Programs for Individuals With Severe Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330329
• Other study ID #: 0209-10
• Status: Completed
• Phase: N/A
• First received: April 5, 2011
• Last updated: April 18, 2012
• Start date: March 2011
• Est. completion date: October 2011

Study information

• Verified date: April 2012
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight		6-months	No
Secondary	Change in physical activity		6-months	No