Expired Study
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Boston, Massachusetts 02215


Purpose:

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.


Criteria:

Inclusion Criteria: 1. Patients who have undergone bariatric surgery 1-5 years prior to study start (by medical record and/or self report) 2. Weight loss plateau (< 5 lbs weight loss in past month) (by medical report and/or self report) 3. Ages 18-65 years (by medical record and/or self report) 4. Able to complete outcome assessments Exclusion Criteria: 1. 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). 2. Plans to leave the study area within next 12 months 3. Serious psychiatric illness or personality disorder (by medical record and/or self-report) 4. Current alcohol and/or substance abuse 5. Pregnancy or plans to become pregnant in next year 6. Non-English speaking 7. > 1 prior weight loss surgery (by medical record and self-report) 8. Gastric band removed prior to study contact.


NCT ID:

NCT02603601


Primary Contact:

Principal Investigator
Christina C Wee, MD, MPH
Beth Israel Deaconess Medical Center


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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