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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03488966

Collaborator

(none)

Enrollment

Location

Arms

69.4

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Morbid Eating Disorder Symptom	Behavioral: Mindfulness Based Eating and Awareness Training	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 20, 2017

Actual Primary Completion Date :

Dec 31, 2018

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).