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Clinical Trials/NCT02189187
NCT02189187
Completed
Not Applicable

Keeping Weight Off: Brain Changes Associated With Healthy Behaviors

University of Massachusetts, Worcester1 site in 1 country55 target enrollmentDecember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight
Sponsor
University of Massachusetts, Worcester
Enrollment
55
Locations
1
Primary Endpoint
Functional connectivity on fMRI
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The goal of this project is to characterize changes in emotion regulation pathways associated with healthy behaviors in people who have recently lost weight and are seeking to maintain weight loss over a 1-year period.

Detailed Description

Unhealthy behaviors such as overeating and a sedentary lifestyle are largely responsible for overweight and obesity which substantially increase risk for chronic conditions such as heart disease, high blood pressure, stroke, diabetes, arthritis and certain cancers. The rapid rise in obesity threatens to reverse recent gains in life expectancy and account for a large percentage of premature deaths in the U.S. Although there is evidence for the short-term efficacy of a number of methods for initiating health behavior change to lose weight, these interventions have shown only limited ability to affect significant, long-term behavioral changes in the majority of adults. In part this may be because they fail to adequately address how psychological factors that lead to relapse to unhealthy behaviors and failure to maintain long-term behavior change. The purpose of the study is to understand brain changes that accompany participation in programs that foster healthy behaviors in people seeking to maintain weight loss. We will use MRI scans to study brain function in men and women 25-60 years old who have lost weight in the last year without surgery. Participants will be assigned to one of two programs to help them maintain weight loss and will be compensated for their time. Our goal is to gain a better understanding of the brain changes that lead to long-term success in keeping weight off, in the hope that this knowledge will assist in the development of improved treatments.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
July 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Massachusetts, Worcester
Responsible Party
Principal Investigator
Principal Investigator

Carl Fulwiler

Associate Professor of Psychiatry

University of Massachusetts, Worcester

Eligibility Criteria

Inclusion Criteria

  • 25 to 60 years old
  • Healthy individuals who have intentionally lost at least 5% of their body weight over the past year
  • BMI \>20.5 kg/m2 at study entry and \>25 in past 2 years

Exclusion Criteria

  • Weight-loss surgery or medications
  • Serious Psychiatric or medical conditions
  • Substance abuse
  • Ineligible for MRI
  • Eating disorder

Outcomes

Primary Outcomes

Functional connectivity on fMRI

Time Frame: 8 weeks

Functional Magnetic Resonance Imaging (fMRI)

Secondary Outcomes

  • Association of functional connectivity with maintenance of weight loss(6 months)
  • Association of functional connectivity change with changes in depression symptoms(6 months)

Study Sites (1)

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