A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Gain
• Intervention / Treatment: Behavioral: Standard lifestyle intervention; Behavioral: Mind-body lifestyle intervention

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconness Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Biomarkers of stress measured by bioassay techniques	12 ± 2 weeks
Biomarkers of inflammation measured by bioassay techniques	12 ± 2 weeks
Food-related attentional bias as measured by the Food-related Stroop task.	12 ± 2 weeks

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Center for Nutritional Research Charitable Trust
• Investigators: Principal Investigator: Christina C Wee, MD, MPH, Beth Israel Deaconess Medical Center

Publications and helpful links

General Publications

• Chacko SA, Yeh GY, Davis RB, Wee CC. A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial. Complement Ther Med. 2016 Oct;28:13-21. doi: 10.1016/j.ctim.2016.07.001. Epub 2016 Jul 12.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 13, 2015

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Randomized controlled trial; Mindfulness
• Additional Relevant MeSH Terms: Body Weight Changes; Body Weight; Weight Gain
• Other Study ID Numbers: 2013P000259