Keeping Weight Off: Brain Changes Associated With Healthy Behaviors

• ClinicalTrials.gov Identifier: NCT02189187
• Recruitment Status: Completed
• First Posted: July 14, 2014
• Last Update Posted: July 31, 2017
• Sponsor: University of Massachusetts, Worcester
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Carl Fulwiler, University of Massachusetts, Worcester

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Overweight; Obesity	Behavioral: Mindfulness; Behavioral: Psychoeducation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Keeping Weight Off: Brain Changes Associated With Healthy Behaviors
• Study Start Date: December 2014
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: July 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: Mindfulness
Active Comparator: 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).	Behavioral: Psychoeducation

Outcome Measures

Primary Outcome Measures :

1. Functional connectivity on fMRI [ Time Frame: 8 weeks ]
   Functional Magnetic Resonance Imaging (fMRI)

Secondary Outcome Measures :

1. Association of functional connectivity change with changes in depression symptoms [ Time Frame: 6 months ]
   Center for Epidemiological Studies-Depression Scale (CES-D)
2. Association of functional connectivity with maintenance of weight loss [ Time Frame: 6 months ]
   BMI

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Massachusetts

Umass Medical School

Worcester, Massachusetts, United States, 01655

Sponsors and Collaborators

University of Massachusetts, Worcester

National Center for Complementary and Integrative Health (NCCIH)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Carl Fulwiler, Associate Professor of Psychiatry, University of Massachusetts, Worcester
• ClinicalTrials.gov Identifier: NCT02189187
• Other Study ID Numbers: 5R34AT006963 ( U.S. NIH Grant/Contract )
• First Posted: July 14, 2014
• Last Update Posted: July 31, 2017
• Last Verified: July 2017

Keywords provided by Carl Fulwiler, University of Massachusetts, Worcester:

Weight Loss; Body Weight Changes; Body Weight; Magnetic Resonance Imaging; Emotions; Emotion regulation; Health Behavior; Eating behavior

Additional relevant MeSH terms:

Overweight; Body Weight