Keeping Weight Off: Brain Changes Associated With Healthy Behaviors

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Behavioral: Mindfulness; Behavioral: Psychoeducation

• Registration Number: NCT02189187
• Lead Sponsor: University of Massachusetts, Worcester

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.

Study Timeline

• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-14
• Study Start: 2014-12
• Primary Completion: 2016-06
• Status Verified: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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
• Pregnant
• Eating disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Based Stress Reduction (MBSR) program	Mindfulness	Mindfulness Based Stress Reduction (MBSR) is an 8-week program that consists of training in mindfulness practices, the application of mindfulness to daily life, and information about healthy living and the role played by thoughts and emotions in health.
Healthy Living Course (HLC)	Psychoeducation	Healthy Living Course (HLC) an 8-week psycho-educational program that consists of lectures and discussion on healthy living, stress management, time management, and unhealthy behaviors (e.g. smoking, drinking).

Primary Outcome Measures

Name	Time	Method
Functional connectivity on fMRI	8 weeks	Functional Magnetic Resonance Imaging (fMRI)

Secondary Outcome Measures

Name	Time	Method
Association of functional connectivity with maintenance of weight loss	6 months	BMI
Association of functional connectivity change with changes in depression symptoms	6 months	Center for Epidemiological Studies-Depression Scale (CES-D)

Trial Locations

Locations (1)

Umass Medical School; 🇺🇸 Worcester, Massachusetts, United States