Clinical trial NCT03488966: Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Eating Disorder Symptom
Keywords: Mindfulness
Bariatric Surgery
Obesity
Group psychotherapy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: Change from baseline to 8 weeks, 6 months, and 12 months
measure: Change in weight
timeFrame: Change from baseline to 8 weeks, 6 months, and 12 months
measure: Height
timeFrame: Baseline
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline to 8 weeks, 6 months, and 12 months
measure: Generalized Anxiety Disorder Questionnaire (GAD-7)
timeFrame: Change from baseline to 8 weeks, 6 months, and 12 months
measure: The Three Factor Eating Questionnaire -R18 (TFEQ-R18)
timeFrame: Change from baseline to 8 weeks, 6 months, and 12 months
measure: Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: Change from baseline to 8 weeks, 6 months, and 12 months
measure: Self-Compassion Scale (SCS)
timeFrame: Change from baseline to 8 weeks, 6 months, and 12 months
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Change from baseline to 8 weeks, 6 months, and 12 months
measure: Body Satisfaction Questionnaire (BSQ)
timeFrame: Change from baseline to 8 weeks, 6 months, and 12 months
measure: Body Parts Satisfaction Scale (BPSS)
timeFrame: Change from baseline to 8 weeks, 6 months, and 12 months
measure: The Dichotomous Thinking Scale (DTS)
timeFrame: Change from baseline to 8 weeks, 6 months, and 12 months
measure: The Obesity Cognitions Scale
timeFrame: Change from baseline to 8 weeks, 6 months, and 12 months
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Change from baseline to 8 weeks, 6 months, and 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Susan Wnuk, Ph.D
role: PRINCIPAL_INVESTIGATOR
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