Keeping Weight Off: Brain Changes Associated With Healthy Behaviors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Keeping Weight Off: Brain Changes Associated With Healthy Behaviors

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Mindfulness
* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Based Stress Reduction (MBSR) program<br>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. | Behavioral: Mindfulness<br> <br> |
| Active Comparator: Healthy Living Course (HLC)<br>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). | Behavioral: Psychoeducation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional connectivity on fMRI | Functional Magnetic Resonance Imaging (fMRI) | 8 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss, Body Weight Changes, Body Weight, Magnetic Resonance Imaging, Emotions, Emotion regulation, Health Behavior, Eating behavior