Keeping Weight Off: Brain Changes Associated With Healthy Behaviors

NCT ID: NCT02189187

Last Updated: 2017-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-07-31

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.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mindfulness Based Stress Reduction (MBSR) program

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.

Group Type: EXPERIMENTAL

Mindfulness

Intervention Type: BEHAVIORAL

Healthy Living Course (HLC)

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).

Group Type: ACTIVE_COMPARATOR

Psychoeducation

Intervention Type: BEHAVIORAL

Interventions

Mindfulness

Intervention Type: BEHAVIORAL

Psychoeducation

Intervention Type: BEHAVIORAL

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
• Pregnant
• Eating disorder

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Carl Fulwiler

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Umass Medical School

Worcester, Massachusetts, United States

Countries

United States

References

Fulwiler C, Siegel JA, Allison J, Rosal MC, Brewer J, King JA. Keeping Weight Off: study protocol of an RCT to investigate brain changes associated with mindfulness-based stress reduction. BMJ Open. 2016 Nov 30;6(11):e012573. doi: 10.1136/bmjopen-2016-012573.

Reference Type: DERIVED

PMID: 27903561 (View on PubMed)

Other Identifiers

5R34AT006963

Identifier Type: NIH

Identifier Source: org_study_id

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