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

Primary Purpose

Obesity, Morbid, Eating Disorder Symptom

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness Based Eating and Awareness Training
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring Mindfulness, Bariatric Surgery, Obesity, Group psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Toronto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MB-EAT

Waitlist Control

Arm Description

Behavioral: group psychotherapy. Eight weekly sessions, each session is 2 hours in duration.

Wait list control.

Outcomes

Primary Outcome Measures

Change in Body Mass Index (BMI)
BMI as calculated by weight (kg) / height (cm)^2
Change in weight
Weight in kilograms will be obtained by weighing participants
Height
Height in centimetres will be obtained by measuring participants

Secondary Outcome Measures

Patient Health Questionnaire (PHQ-9)
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.
Generalized Anxiety Disorder Questionnaire (GAD-7)
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.
The Three Factor Eating Questionnaire -R18 (TFEQ-R18)
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.
Five Facets of Mindfulness Questionnaire (FFMQ)
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.
Self-Compassion Scale (SCS)
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.
Difficulties in Emotion Regulation Scale (DERS)
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.
Body Satisfaction Questionnaire (BSQ)
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.
Body Parts Satisfaction Scale (BPSS)
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.
The Dichotomous Thinking Scale (DTS)
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.
The Obesity Cognitions Scale
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.
Gastrointestinal Symptom Rating Scale (GSRS)
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.

Full Information

First Posted
November 15, 2017
Last Updated
May 19, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03488966
Brief Title
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Acronym
MB-EAT
Official Title
Mindfulness Based Eating Awareness Training (MB-EAT) for Bariatric Surgery Patients: The Effects of Mindfulness on Psychosocial and Physical Functioning
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Eating Disorder Symptom
Keywords
Mindfulness, Bariatric Surgery, Obesity, Group psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MB-EAT
Arm Type
Experimental
Arm Description
Behavioral: group psychotherapy. Eight weekly sessions, each session is 2 hours in duration.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Wait list control.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Eating and Awareness Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Mass Index (BMI)
Description
BMI as calculated by weight (kg) / height (cm)^2
Time Frame
Change from baseline to 8 weeks, 6 months, and 12 months
Title
Change in weight
Description
Weight in kilograms will be obtained by weighing participants
Time Frame
Change from baseline to 8 weeks, 6 months, and 12 months
Title
Height
Description
Height in centimetres will be obtained by measuring participants
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Change from baseline to 8 weeks, 6 months, and 12 months
Title
Generalized Anxiety Disorder Questionnaire (GAD-7)
Description
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.
Time Frame
Change from baseline to 8 weeks, 6 months, and 12 months
Title
The Three Factor Eating Questionnaire -R18 (TFEQ-R18)
Description
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.
Time Frame
Change from baseline to 8 weeks, 6 months, and 12 months
Title
Five Facets of Mindfulness Questionnaire (FFMQ)
Description
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.
Time Frame
Change from baseline to 8 weeks, 6 months, and 12 months
Title
Self-Compassion Scale (SCS)
Description
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.
Time Frame
Change from baseline to 8 weeks, 6 months, and 12 months
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
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.
Time Frame
Change from baseline to 8 weeks, 6 months, and 12 months
Title
Body Satisfaction Questionnaire (BSQ)
Description
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.
Time Frame
Change from baseline to 8 weeks, 6 months, and 12 months
Title
Body Parts Satisfaction Scale (BPSS)
Description
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.
Time Frame
Change from baseline to 8 weeks, 6 months, and 12 months
Title
The Dichotomous Thinking Scale (DTS)
Description
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.
Time Frame
Change from baseline to 8 weeks, 6 months, and 12 months
Title
The Obesity Cognitions Scale
Description
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.
Time Frame
Change from baseline to 8 weeks, 6 months, and 12 months
Title
Gastrointestinal Symptom Rating Scale (GSRS)
Description
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.
Time Frame
Change from baseline to 8 weeks, 6 months, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Fluent in English. Have the capacity to provide informed consent. Exclusion Criteria: Active suicidal ideation. Active serious mental illness (i.e., psychotic disorder, bipolar disorder). Active severe depression (i.e., current major depressive disorder diagnosis and PHQ-9 score > 20 [severe depression]). Active severe anxiety (i.e., current anxiety disorder diagnosis and GAD-7 score > 15 [severe anxiety]). Active symptoms of post-traumatic stress disorder (i.e., current diagnosis of post-traumatic stress disorder).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Wnuk, Ph.D
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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14574339
Citation
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Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients

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