NCT02603601

A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Weight Gain

Interventions

Type	Name	Description
BEHAVIORAL	Mind-body lifestyle intervention
BEHAVIORAL	Standard lifestyle intervention

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2015-11-13
• Last updated: 2017-05-03

Locations

1 site across 1 country: United States