Skip to main content
OpenTrials
Completed

NCT Number: NCT01330329

Comparison of Weight Loss Programs for Individuals With Severe Obesity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Behavioral Treatment

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.

SBT + technology system (SBT+FIT)

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.

Primary outcomes

  1. Change in body weight

    Time frame: 6-months

Secondary outcomes

  1. Change in physical activity

    Time frame: 6-months

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 6, 2011
Registry last updated
Apr 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.