A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery

Not Applicable

Completed

• Conditions: Weight Gain; Obesity

• Registration Number: NCT02603601
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-13
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
Success meeting recruitment goals (20 patients within 3-4 months)	4-month recruitment window

Secondary Outcome Measures

Name	Time	Method
Eating behaviors measured using the Three Factor Eating Questionnaire	12 ± 2 weeks
Changes in body weight as measured on a digital scale	12 ± 2 weeks post intervention-baseline
Eating behaviors measured using the Binge Eating 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
Ability to cope measured by the Brief Cope questionnaire	12 ± 2 weeks
Quality of life measured using the Medical Outcomes Study Short-Form-36 scale	12 ± 2 weeks
Perceived stress measured by the Perceived Stress Scale	12 ± 2 weeks
Eating self-efficacy measured by the Weight Efficacy Lifestyle Questionnaire	12 ± 2 weeks

Trial Locations

Locations (1)

Beth Israel Deaconness Medical Center; 🇺🇸 Boston, Massachusetts, United States