A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
Primary Purpose
Obesity, Weight Gain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mind-body lifestyle intervention
Standard lifestyle intervention
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Randomized controlled trial, Mindfulness, Obesity
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Beth Israel Deaconness Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard lifestyle intervention
Mind-body lifestyle intervention
Arm Description
The standard lifestyle intervention is a 1-hour individual nutritional counseling session with a registered dietician at BIDMC.
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.
Outcomes
Primary Outcome Measures
Success meeting recruitment goals (20 patients within 3-4 months)
Willingness to participate in study (>10% of eligible)
Adherence rate (≥70% attendance, 7 of 10 classes)
Retention (≤25% drop-out)
Secondary Outcome Measures
Changes in body weight as measured on a digital scale
Eating behaviors measured using the Three Factor Eating Questionnaire
Eating behaviors measured using the Binge Eating Scale
Quality of life measured using the Medical Outcomes Study Short-Form-36 scale
Quality of life measured using the Impact of Weight on Quality of Life scale
Depression measured by the Center for Epidemiologic Studies Depression Scale
Perceived stress measured by the Perceived Stress Scale
Ability to cope measured by the Brief Cope questionnaire
Eating self-efficacy measured by the Weight Efficacy Lifestyle Questionnaire
Full Information
NCT ID
NCT02603601
First Posted
February 4, 2015
Last Updated
May 2, 2017
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Center for Nutritional Research Charitable Trust
1. Study Identification
Unique Protocol Identification Number
NCT02603601
Brief Title
A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
Official Title
A Randomized Controlled Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Center for Nutritional Research Charitable Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Gain
Keywords
Randomized controlled trial, Mindfulness, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard lifestyle intervention
Arm Type
Active Comparator
Arm Description
The standard lifestyle intervention is a 1-hour individual nutritional counseling session with a registered dietician at BIDMC.
Arm Title
Mind-body lifestyle intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mind-body lifestyle intervention
Intervention Type
Behavioral
Intervention Name(s)
Standard lifestyle intervention
Primary Outcome Measure Information:
Title
Success meeting recruitment goals (20 patients within 3-4 months)
Time Frame
4-month recruitment window
Title
Willingness to participate in study (>10% of eligible)
Time Frame
4-month recuitment window
Title
Adherence rate (≥70% attendance, 7 of 10 classes)
Time Frame
12-weeks
Title
Retention (≤25% drop-out)
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Changes in body weight as measured on a digital scale
Time Frame
12 ± 2 weeks post intervention-baseline
Title
Eating behaviors measured using the Three Factor Eating Questionnaire
Time Frame
12 ± 2 weeks
Title
Eating behaviors measured using the Binge Eating Scale
Time Frame
12 ± 2 weeks
Title
Quality of life measured using the Medical Outcomes Study Short-Form-36 scale
Time Frame
12 ± 2 weeks
Title
Quality of life measured using the Impact of Weight on Quality of Life scale
Time Frame
12 ± 2 weeks
Title
Depression measured by the Center for Epidemiologic Studies Depression Scale
Time Frame
12 ± 2 weeks
Title
Perceived stress measured by the Perceived Stress Scale
Time Frame
12 ± 2 weeks
Title
Ability to cope measured by the Brief Cope questionnaire
Time Frame
12 ± 2 weeks
Title
Eating self-efficacy measured by the Weight Efficacy Lifestyle Questionnaire
Time Frame
12 ± 2 weeks
Other Pre-specified Outcome Measures:
Title
Biomarkers of stress measured by bioassay techniques
Time Frame
12 ± 2 weeks
Title
Biomarkers of inflammation measured by bioassay techniques
Time Frame
12 ± 2 weeks
Title
Food-related attentional bias as measured by the Food-related Stroop task.
Time Frame
12 ± 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina C Wee, MD, MPH
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconness Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27670865
Citation
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.
Results Reference
derived
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A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
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