A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard lifestyle intervention The standard lifestyle intervention is a 1-hour individual nutritional counseling session with a registered dietician at BIDMC. |
Behavioral: Standard lifestyle intervention
|
| Experimental: Mind-body lifestyle intervention 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. |
Behavioral: Mind-body lifestyle intervention
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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]
- 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]
Other Outcome Measures
- 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. [12 ± 2 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients who have undergone bariatric surgery 1-5 years prior to study start (by medical record and/or self report)
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Weight loss plateau (< 5 lbs weight loss in past month) (by medical report and/or self report)
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Ages 18-65 years (by medical record and/or self report)
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Able to complete outcome assessments
Exclusion Criteria:
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Prior experience with meditation course (past 6 months), current mindfulness/meditation practice, or regular meditation or mindfulness practice in past year ("Regular practice" defined as practicing formally 1 or more times a week for 2 months).
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Plans to leave the study area within next 12 months
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Serious psychiatric illness or personality disorder (by medical record and/or self-report)
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Current alcohol and/or substance abuse
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Pregnancy or plans to become pregnant in next year
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Non-English speaking
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1 prior weight loss surgery (by medical record and self-report)
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Gastric band removed prior to study contact.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beth Israel Deaconness Medical Center | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Beth Israel Deaconess Medical Center
- Center for Nutritional Research Charitable Trust
Investigators
- Principal Investigator: Christina C Wee, MD, MPH, Beth Israel Deaconess Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2013P000259