A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery

Completed · Not applicable

Conditions studied: Obesity, Weight Gain

In brief

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.

Key facts

Study ID

NCT02603601

Run by

Beth Israel Deaconess Medical Center

People needed

18

Starts

2014-03-01

Expected to finish

2014-10-01

Last updated by the study team

2017-05-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Beth Israel Deaconness Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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