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Keeping Weight Off: Brain Changes Associated With Healthy Behaviors

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

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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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
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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
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Information from the National Library of Medicine

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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189187


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

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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    Key Record Dates
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:
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Overweight
Body Weight
Signs and Symptoms