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Obesity, MorbidMB-EATNCT03488966

Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients

A study testing Mindfulness Based Eating and Awareness Training in people with Obesity, Morbid and Eating Disorder Symptom, run by University Health Network, Toronto at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity, Morbid, Eating Disorder Symptom
What is being tested?
Mindfulness Based Eating and Awareness Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteCanada
Study dates
20 Mar 2017to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Mindfulness Based Eating and Awareness Training
Keywords
Mindfulness, Bariatric Surgery, Obesity, Group psychotherapy
Medical subject headings
Obesity, Morbid, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Based Eating and Awareness TrainingBehavioural

    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.

Study groups in NCT03488966
Study groupRoleWhat they receive
MB-EATExperimentalBehavioral: group psychotherapy. Eight weekly sessions, each session is 2 hours in duration.
Receives: Behavioral: Mindfulness Based Eating and Awareness Training
Waitlist ControlNo interventionWait list control.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body Mass Index (BMI)

    BMI as calculated by weight (kg) / height (cm)^2

    Measured: Change from baseline to 8 weeks, 6 months, and 12 months

  2. Change in weight

    Weight in kilograms will be obtained by weighing participants

    Measured: Change from baseline to 8 weeks, 6 months, and 12 months

  3. Height

    Height in centimetres will be obtained by measuring participants

    Measured: Baseline

Secondary outcomes (11)
  1. 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.

    Measured: Change from baseline to 8 weeks, 6 months, and 12 months

  2. 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.

    Measured: Change from baseline to 8 weeks, 6 months, and 12 months

  3. 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.

    Measured: Change from baseline to 8 weeks, 6 months, and 12 months

  4. 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.

    Measured: Change from baseline to 8 weeks, 6 months, and 12 months

  5. 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.

    Measured: Change from baseline to 8 weeks, 6 months, and 12 months

  6. 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.

    Measured: Change from baseline to 8 weeks, 6 months, and 12 months

  7. 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.

    Measured: Change from baseline to 8 weeks, 6 months, and 12 months

  8. 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.

    Measured: Change from baseline to 8 weeks, 6 months, and 12 months

  9. 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.

    Measured: Change from baseline to 8 weeks, 6 months, and 12 months

  10. 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.

    Measured: Change from baseline to 8 weeks, 6 months, and 12 months

  11. 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.

    Measured: Change from baseline to 8 weeks, 6 months, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2018
  2. Study start20 Mar 2017
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03488966
Sponsor's protocol ID
16-5731
Acronym
MB-EAT
Status last verified
Sep 2026
First submitted
15 Nov 2017
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Herpertz S, Kielmann R, Wolf AM, Langkafel M, Senf W, Hebebrand J. Does obesity surgery improve psychosocial functioning? A systematic review. Int J Obes Relat Metab Disord. 2003 Nov;27(11):1300-14. doi: 10.1038/sj.ijo.0802410.

    PubMed 14574339
  • Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.

    PubMed 20350028
  • Adams CE, Benitez L, Kinsaul J, Apperson McVay M, Barbry A, Thibodeaux A, Copeland AL. Effects of brief mindfulness instructions on reactions to body image stimuli among female smokers: an experimental study. Nicotine Tob Res. 2013 Feb;15(2):376-84. doi: 10.1093/ntr/nts133. Epub 2012 Sep 17.

    PubMed 22987786
  • Alberts HJ, Thewissen R, Raes L. Dealing with problematic eating behaviour. The effects of a mindfulness-based intervention on eating behaviour, food cravings, dichotomous thinking and body image concern. Appetite. 2012 Jun;58(3):847-51. doi: 10.1016/j.appet.2012.01.009. Epub 2012 Jan 10.

    PubMed 22265753
  • Beck NN, Johannsen M, Stoving RK, Mehlsen M, Zachariae R. Do postoperative psychotherapeutic interventions and support groups influence weight loss following bariatric surgery? A systematic review and meta-analysis of randomized and nonrandomized trials. Obes Surg. 2012 Nov;22(11):1790-7. doi: 10.1007/s11695-012-0739-4.

    PubMed 22930073
  • Dalen J, Smith BW, Shelley BM, Sloan AL, Leahigh L, Begay D. Pilot study: Mindful Eating and Living (MEAL): weight, eating behavior, and psychological outcomes associated with a mindfulness-based intervention for people with obesity. Complement Ther Med. 2010 Dec;18(6):260-4. doi: 10.1016/j.ctim.2010.09.008. Epub 2010 Nov 11.

    PubMed 21130363
  • Godsey J. The role of mindfulness based interventions in the treatment of obesity and eating disorders: an integrative review. Complement Ther Med. 2013 Aug;21(4):430-9. doi: 10.1016/j.ctim.2013.06.003. Epub 2013 Jul 9.

    PubMed 23876574
  • Greeson JM. Mindfulness Research Update: 2008. Complement Health Pract Rev. 2009 Jan 1;14(1):10-18. doi: 10.1177/1533210108329862.

    PubMed 20047019
  • Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. doi: 10.1016/S0022-3999(03)00573-7.

    PubMed 15256293
  • Heatherton TF, Baumeister RF. Binge eating as escape from self-awareness. Psychol Bull. 1991 Jul;110(1):86-108. doi: 10.1037/0033-2909.110.1.86.

    PubMed 1891520
  • Kalarchian MA, Wilson GT, Brolin RE, Bradley L. Binge eating in bariatric surgery patients. Int J Eat Disord. 1998 Jan;23(1):89-92. doi: 10.1002/(sici)1098-108x(199801)23:13.0.co;2-i.

    PubMed 9429923
  • Kristeller JL, Hallett CB. An Exploratory Study of a Meditation-based Intervention for Binge Eating Disorder. J Health Psychol. 1999 May;4(3):357-63. doi: 10.1177/135910539900400305.

    PubMed 22021603
  • Odom J, Zalesin KC, Washington TL, Miller WW, Hakmeh B, Zaremba DL, Altattan M, Balasubramaniam M, Gibbs DS, Krause KR, Chengelis DL, Franklin BA, McCullough PA. Behavioral predictors of weight regain after bariatric surgery. Obes Surg. 2010 Mar;20(3):349-56. doi: 10.1007/s11695-009-9895-6. Epub 2009 Jun 25.

    PubMed 19554382

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Based Eating and Awareness Training in people with Obesity, Morbid and Eating Disorder Symptom, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Mass Index (BMI) (time frame: Change from baseline to 8 weeks, 6 months, and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03488966, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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