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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) program | Experimental | 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) | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness | Behavioral |
| ||
| Psychoeducation |
| Measure | Description | Time Frame |
|---|---|---|
| Functional connectivity on fMRI | Functional Magnetic Resonance Imaging (fMRI) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Association of functional connectivity change with changes in depression symptoms | Center for Epidemiological Studies-Depression Scale (CES-D) | 6 months |
| Association of functional connectivity with maintenance of weight loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umass Medical School | Worcester | Massachusetts | 01655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27903561 | Derived | 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. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D000080103 | Emotional Regulation |
| D015438 | Health Behavior |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Behavioral |
|
BMI
| 6 months |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D001522 | Behavior, Animal |