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Trial record 40 of 127 for:    Recruiting, Not yet recruiting, Available Studies | "Eating Disorders"

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

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ClinicalTrials.gov Identifier: NCT03488966
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 72 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 : March 20, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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

  2. 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

  3. Height [ Time Frame: Baseline ]
    Height in centimetres will be obtained by measuring participants


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Post-bariatric surgery patients recruited from the 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488966


Contacts
Contact: Poponne Nerissa, R.Kin (Inactive), B.Sc.,PGCHI 416-581-7525 capcr@uhnresearch.ca

Locations
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Nerissa Poponne, R.Kin (Inactive), B.Sc.,PGCHI    416-581-7525    capcr@uhnresearch.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Susan Wnuk, Ph.D University Health Network, Toronto

Publications of Results:

Other Publications:
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03488966     History of Changes
Other Study ID Numbers: 16-5731-BE
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Health Network, Toronto:
Mindfulness
Bariatric Surgery
Obesity
Group psychotherapy

Additional relevant MeSH terms:
Feeding and Eating Disorders
Obesity, Morbid
Mental Disorders
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms