Comparison of Weight Loss Programs for Individuals With Severe Obesity

NCT ID: NCT01330329

Last Updated: 2012-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-10-31

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.

Conditions

Obesity; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SBT + technology system (SBT+FIT)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Standard behavioral treatment

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jessica Unick

Assistant Professor (Research)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rena Wing, PhD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Locations

Weight Control and Diabetes Research Center

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25778833 (View on PubMed)

Other Identifiers

0209-10

Identifier Type: -

Identifier Source: org_study_id