A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery

Conditions
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Obesity, Weight Gain

Intervention / Treatment
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* Behavioral: Mind-body lifestyle intervention
* Behavioral: Standard lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have undergone bariatric surgery 1-5 years prior to study start (by medical record and/or self report) Weight loss plateau (< 5 lbs weight loss in past month) (by medical report and/or self report) Ages 18-65 years (by medical record and/or self report) Able to complete outcome assessments Exclusion Criteria: 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). Plans to leave the study area within next 12 months Serious psychiatric illness or personality disorder (by medical record and/or self-report) Current alcohol and/or substance abuse Pregnancy or plans to become pregnant in next year Non-English speaking > 1 prior weight loss surgery (by medical record and self-report) Gastric band removed prior to study contact.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard lifestyle intervention<br>The standard lifestyle intervention is a 1-hour individual nutritional counseling session with a registered dietician at BIDMC. | Behavioral: Standard lifestyle intervention<br> <br> |
| Experimental: Mind-body lifestyle intervention<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Mindfulness, Obesity