Keeping Weight Off: Brain Changes Associated With Healthy Behaviors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02189187|
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : July 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Behavioral: Mindfulness Behavioral: Psychoeducation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
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).
- Functional connectivity on fMRI [ Time Frame: 8 weeks ]Functional Magnetic Resonance Imaging (fMRI)
- Association of functional connectivity change with changes in depression symptoms [ Time Frame: 6 months ]Center for Epidemiological Studies-Depression Scale (CES-D)
- Association of functional connectivity with maintenance of weight loss [ Time Frame: 6 months ]BMI
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
|United States, Massachusetts|
|Umass Medical School|
|Worcester, Massachusetts, United States, 01655|