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Keeping Weight Off: Brain Changes Associated With Healthy Behaviors

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Psychoeducation
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Weight Loss, Body Weight Changes, Body Weight, Magnetic Resonance Imaging, Emotions, Emotion regulation, Health Behavior, Eating behavior

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Umass Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Based Stress Reduction (MBSR) program

Healthy Living Course (HLC)

Arm Description

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) 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).

Outcomes

Primary Outcome Measures

Functional connectivity on fMRI
Functional Magnetic Resonance Imaging (fMRI)

Secondary Outcome Measures

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

Full Information

First Posted
June 24, 2014
Last Updated
July 26, 2017
Sponsor
University of Massachusetts, Worcester
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02189187
Brief Title
Keeping Weight Off: Brain Changes Associated With Healthy Behaviors
Official Title
Keeping Weight Off: Brain Changes Associated With Healthy Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Weight Loss, Body Weight Changes, Body Weight, Magnetic Resonance Imaging, Emotions, Emotion regulation, Health Behavior, Eating behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Stress Reduction (MBSR) program
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Living Course (HLC)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Primary Outcome Measure Information:
Title
Functional connectivity on fMRI
Description
Functional Magnetic Resonance Imaging (fMRI)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Association of functional connectivity change with changes in depression symptoms
Description
Center for Epidemiological Studies-Depression Scale (CES-D)
Time Frame
6 months
Title
Association of functional connectivity with maintenance of weight loss
Description
BMI
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Umass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27903561
Citation
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.
Results Reference
derived

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Keeping Weight Off: Brain Changes Associated With Healthy Behaviors

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