Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients (MB-EAT)

May 27, 2024 updated by: University Health Network, Toronto

Mindfulness Based Eating Awareness Training (MB-EAT) for Bariatric Surgery Patients: The Effects of Mindfulness on Psychosocial and Physical Functioning

The purpose of this study is to evaluate the effects of Mindfulness Based Eating Awareness Training (MB-EAT) for patients who have had bariatric surgery on their weight and mental and physical health compared to patients who do not do this group. All participants will complete questionnaires evaluating eating and mental health before and after the group and 6 and 12 months later. They will have blood pressure readings at these times and complete a questionnaire about their digestive health. Our hypothesis is that participants will maintain their weight loss after bariatric surgery and have improvements in the other outcomes.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

MB-EAT may be helpful for reducing emotional eating, overeating and grazing, eating patterns that can lead to weight gain after bariatric surgery. Participants will receive MB-EAT 6 months or more following bariatric surgery. They will be randomly assigned to receive MB-EAT right away or 8 weeks later. Individuals in the group starting in 8 weeks will serve as a waitlist control group.The primary outcome measures will be changes in self-reported eating problems, depression, anxiety, and mindfulness. There will be a follow-up at 6 months and 12 months to establish stability of symptoms post-intervention. Participants will receive one introductory information session about the MB-EAT program, as well as 8 MB-EAT scheduled consecutively over eight weeks. Each session is approximately two hours in length. During MB-EAT, participants will practice mindfulness to help improve their decision making abilities about when and how much to eat. Through MB-EAT, participants will learn to address mindless or out-of-control eating, which can lead to weight gain. Homework will include daily meditations and mindful eating exercises.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Post-bariatric surgery patients recruited from the Toronto Western Hospital-Bariatric Surgery Program (TWH-BSP) who are six months or more post-surgery, are experiencing self-reported difficulties adhering to post-surgery eating guidelines, and can commit to attending the group.
  2. Fluent in English.
  3. Have the capacity to provide informed consent.

Exclusion Criteria:

  1. Active suicidal ideation.
  2. Active serious mental illness (i.e., psychotic disorder, bipolar disorder).
  3. Active severe depression (i.e., current major depressive disorder diagnosis and PHQ-9 score > 20 [severe depression]).
  4. Active severe anxiety (i.e., current anxiety disorder diagnosis and GAD-7 score > 15 [severe anxiety]).
  5. Active symptoms of post-traumatic stress disorder (i.e., current diagnosis of post-traumatic stress disorder).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MB-EAT
Behavioral: group psychotherapy. Eight weekly sessions, each session is 2 hours in duration.
Behavioral: Mindfulness Based Eating and Awareness Training
Eight sessions of Mindfulness Based Eating and Awareness Training (MB-EAT) will be delivered once per week over the course of 8 weeks, following an introductory session. The treatment uses general mindfulness meditation and eating meditation to help participants bring greater awareness and understanding to their relationship with food. Homework consists of weekly mindfulness exercises.
No Intervention: Waitlist Control
Wait list control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index (BMI)
Time Frame: Change from baseline to 8 weeks, 6 months, and 12 months
BMI as calculated by weight (kg) / height (cm)^2
Change from baseline to 8 weeks, 6 months, and 12 months
Change in weight
Time Frame: Change from baseline to 8 weeks, 6 months, and 12 months
Weight in kilograms will be obtained by weighing participants
Change from baseline to 8 weeks, 6 months, and 12 months
Height
Time Frame: Baseline
Height in centimetres will be obtained by measuring participants
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-9)
Time Frame: Change from baseline to 8 weeks, 6 months, and 12 months
A 9-item self-report measure of depression severity that yields a total score. Items are scored from 0-3. Higher values mean more depression. The total score is obtained by summing the items.
Change from baseline to 8 weeks, 6 months, and 12 months
Generalized Anxiety Disorder Questionnaire (GAD-7)
Time Frame: Change from baseline to 8 weeks, 6 months, and 12 months
A 7-item self-report measure of anxiety severity that yields a total score. Items are scored from 0-3. Higher values mean more anxiety. The total score is obtained by summing the items.
Change from baseline to 8 weeks, 6 months, and 12 months
The Three Factor Eating Questionnaire -R18 (TFEQ-R18)
Time Frame: Change from baseline to 8 weeks, 6 months, and 12 months
An 18 item self-report measure of eating behavior that yields a total score. Items are scored from 1-4. Higher values mean more anxiety. The total score is obtained by summing the items.
Change from baseline to 8 weeks, 6 months, and 12 months
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: Change from baseline to 8 weeks, 6 months, and 12 months
A 39-item self-report measuring mindfulness that yields a total score. Items are scored from 1-5. Higher values mean more mindfulness except in the case of the following reverse-scored items: 3, 5, 8, 10, 12, 13, 14, 16, 17, 18, 22, 23, 25, 28, 34, 38, 30, 35, 39. After reverse scoring these items a total score is obtained by summing the items. Average score can be computed by dividing the total score by 39.
Change from baseline to 8 weeks, 6 months, and 12 months
Self-Compassion Scale (SCS)
Time Frame: Change from baseline to 8 weeks, 6 months, and 12 months
A 26-item self-report measure of self-compassion that yields a total score. Items are scored from 1-5. Higher values mean more self-compassion except in the case of the following reverse-scored items: 1, 2, 4, 6, 8, 11, 13, 16, 18, 20, 21, 24, 25. After reverse scoring these items a total score is obtained by summing the items. Average score can be computed by dividing the total score by 26.
Change from baseline to 8 weeks, 6 months, and 12 months
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: Change from baseline to 8 weeks, 6 months, and 12 months
A 36-item self-report questionnaire of emotional difficulties that yields a total score. Items are scored from 1-5. Higher values mean more difficulties in emotion regulation, except in the case of the following reverse-scored items: 1, 2, 6, 7, 8, 10, 17, 20, 22, 24, 34. After reverse scoring these items a total score is obtained by summing the items and an average score is obtained by dividing the sum by 36.
Change from baseline to 8 weeks, 6 months, and 12 months
Body Satisfaction Questionnaire (BSQ)
Time Frame: Change from baseline to 8 weeks, 6 months, and 12 months
A 34-item self-report measure of satisfaction with one's overall body that yields a total score. Items are scored from 0-5. Higher values mean more dissatisfaction with one's body. A total score is obtained by summing the items.
Change from baseline to 8 weeks, 6 months, and 12 months
Body Parts Satisfaction Scale (BPSS)
Time Frame: Change from baseline to 8 weeks, 6 months, and 12 months
An 11-item self-report measure of satisfaction with specific body parts that yields a total score. Items are scored from 0-5. Higher values mean more dissatisfaction. A total score is obtained by summing the items.
Change from baseline to 8 weeks, 6 months, and 12 months
The Dichotomous Thinking Scale (DTS)
Time Frame: Change from baseline to 8 weeks, 6 months, and 12 months
An 11-item self-report scale that measures the cognitive distortions and yields a total score. Items are scored from 1-4 with higher scores indication more cognitive distortions. A total score is obtained by summing the items.
Change from baseline to 8 weeks, 6 months, and 12 months
The Obesity Cognitions Scale
Time Frame: Change from baseline to 8 weeks, 6 months, and 12 months
A 15 item scale that measures cognitive distortions surrounding food, weight, and shape that yields a total score. Items are scored from 0-5 with higher scores indication more cognitive distortions. A total score is obtained by summing the items.
Change from baseline to 8 weeks, 6 months, and 12 months
Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame: Change from baseline to 8 weeks, 6 months, and 12 months
A 15 item self-report scale of gastrointestinal symptoms that yields a total score. Items are scored from 0 to 3 with higher scores indicated more frequent gastrointestinal discomfort. A total score is obtained by summing the items.
Change from baseline to 8 weeks, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Susan Wnuk, Ph.D, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

March 28, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 27, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-5731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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