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| Name | Class |
|---|---|
| Center for Nutritional Research Charitable Trust | OTHER |
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This randomized controlled trial is designed to test the feasibility and efficacy of a novel 10-week mindfulness-based intervention (MBI) on weight maintenance as well as behavioral and psychosocial outcomes in patients who have undergone bariatric surgery.
Primary hypothesis:
Bariatric patients who have stopped losing weight (< 5 lbs weight loss in past month) 1-5 years post-surgery will be willing to participate in this 10-week intervention. The investigators expect a high adherence rate (>70%) and no issues with meeting recruitment goals.
Secondary hypotheses:
Patients assigned to the MBI will show greater improvement in a) weight control (defined by differences in body weight between baseline and follow-up); b) eating behaviors (binge eating, emotional eating); and c) psychosocial measures (quality of life, depression, perceived stress, eating self-efficacy, coping ability) than a standard lifestyle intervention (1 hr lifestyle counseling).
Patients assigned to the MBI intervention will show greater improvement in biomarkers of stress and inflammation [salivary cortisol, high sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha)] as compared with a standard lifestyle intervention.
Food-related attentional bias as measured by the food-related Stroop task will be differentially affected among patients assigned to the MBI as compared with the intensive lifestyle intervention and standard lifestyle intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard lifestyle intervention | Active Comparator | The standard lifestyle intervention is a 1-hour individual nutritional counseling session with a registered dietician at BIDMC. |
|
| Mind-body lifestyle intervention | Experimental | The mind-body lifestyle intervention is a 10-week mindfulness-based intervention that integrates mindfulness with traditional behavioral strategies to improve long-term weight maintenance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind-body lifestyle intervention | Behavioral |
| ||
| Standard lifestyle intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Success meeting recruitment goals (20 patients within 3-4 months) | 4-month recruitment window | |
| Willingness to participate in study (>10% of eligible) | 4-month recuitment window | |
| Adherence rate (≥70% attendance, 7 of 10 classes) | 12-weeks | |
| Retention (≤25% drop-out) | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight as measured on a digital scale | 12 ± 2 weeks post intervention-baseline | |
| Eating behaviors measured using the Three Factor Eating Questionnaire | 12 ± 2 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers of stress measured by bioassay techniques | 12 ± 2 weeks | |
| Biomarkers of inflammation measured by bioassay techniques | 12 ± 2 weeks | |
| Food-related attentional bias as measured by the Food-related Stroop task. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina C Wee, MD, MPH | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconness Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27670865 | Derived | Chacko SA, Yeh GY, Davis RB, Wee CC. A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial. Complement Ther Med. 2016 Oct;28:13-21. doi: 10.1016/j.ctim.2016.07.001. Epub 2016 Jul 12. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Behavioral |
|
| Eating behaviors measured using the Binge Eating Scale |
| 12 ± 2 weeks |
| Quality of life measured using the Medical Outcomes Study Short-Form-36 scale | 12 ± 2 weeks |
| Quality of life measured using the Impact of Weight on Quality of Life scale | 12 ± 2 weeks |
| Depression measured by the Center for Epidemiologic Studies Depression Scale | 12 ± 2 weeks |
| Perceived stress measured by the Perceived Stress Scale | 12 ± 2 weeks |
| Ability to cope measured by the Brief Cope questionnaire | 12 ± 2 weeks |
| Eating self-efficacy measured by the Weight Efficacy Lifestyle Questionnaire | 12 ± 2 weeks |
| 12 ± 2 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |