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Eating BehaviorsNCT07131332

Mindfulness-Based Eating Awareness Training for Post-bariatric Surgery Patients

A study testing Mindful eating group in people with Eating Behaviors, run by University Health Network, Toronto.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial was to see if learning and practicing mindful eating in a group was helpful for people who had bariatric surgery. The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Eating Behaviors
What is being tested?
Mindful eating group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
Jun 2015to Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Any patient enrolled in the University Health Network Bariatric Surgery Program
  • Able to speak, read and write English

Who cannot join

  • Inability to speak, read and write English

About this study

Official title: Mindfulness Based Eating and Awareness Training for Post-bariatric Surgery Patients: A Mixed Methods Outcome Study

The goal of this clinical trial was to see if learning and practicing mindful eating in a group was helpful for people who had bariatric surgery. The main questions it aims to answer are:

  1. Does learning and practicing mindful eating help decrease overeating, improve mood, decrease anxiety, and lead to other similar changes?
  2. What do people who participated in a mindful eating group find helpful and hindering about it?
Read more

Participants were asked to:

  • take part in an 8-week mindful eating group
  • complete questionnaires before the group started and after it ended, about their eating habits, mood, anxiety and other similar issues
  • complete a questionnaire right after each session asking them what they found helpful and hindering about that session
Read the detailed description

BACKGROUND: Bariatric surgery, specifically the roux-en-y gastric bypass and gastric sleeve, has been conducted at the University Health Network Surgery Program (UHN-BSP) since late 2009. Weight loss through bariatric surgery is associated with the improvement or resolution of medical comorbidities as well as improvements in patient-reported quality of life. Bariatric surgery is also more successful than other weight loss methods in maintaining weight loss. Therefore, weight regain is of primary concern in this population. Psychiatric factors associated with weight regain include binge eating, lack of control over food urges and a greater number of psychiatric disorders.

Mindfulness meditation techniques may address many of the factors related to disordered eating that contributes to weight regain, including distressing emotions and cognitive distortions. Mindfulness training involves purposeful and sustained attention to thoughts, emotions and bodily sensations. This encourages the recognition of and improved ability to tolerate painful emotions without engaging in problematic behavior like overeating. Mindfulness is a well-validated intervention for psychological and medical problems in other patient populations, including anxiety, depression, stress. Mindfulness-Based Eating Awareness Training (MB-EAT) is a group program developed by Kristeller and colleagues that integrates mindfulness meditation and eating meditation with didactics about healthy eating.

Mindfulness and mindful eating practice may help individuals better recognize and respond to feelings of hunger and fullness. Bariatric surgery patients tend to have a history of multiple weight-loss diet attempts. These diets usually emphasize rules for how much, when and what to eat that paradoxically lead to the loss of one's ability to recognize, accept or respond to internal cues of hunger, taste, satiety, and fullness. Studies that that investigated mindful eating interventions for bariatric surgery patients indicate that they improve eating behavior, emotion regulation, and depression. The investigators conducted one of these studies and found that depression and binge eating significantly decreased from pre to post intervention and emotion regulation significantly improved.

OBJECTIVES:

Primary Objective: To quantitatively investigate the effectiveness of MB-EAT in enhancing psychological functioning as an adjunct treatment to the usual standard of care in the 40 bariatric surgery patients who participated in MB-EAT groups.

Secondary Objective: To qualitatively better understand participants' reactions to MB-EAT, specifically perceptions of helpful and unhelpful aspects, via written comments and ratings that were provided at the end of each session.

HYPOTHESES:

Primary Hypothesis (quantitative): The investigators expect that participants will show improvements in psychological functioning from pre to post-MB-EAT.

Secondary Hypothesis (qualitative): Participants will identify helpful and hindering aspects of MB-EAT in their written feedback after each session.

Outcome Measures (quantitative): The primary outcome measures are changes in self-reported eating pathology, depression, anxiety, interoceptive awareness, mindfulness.

Outcome Measure (qualitative): Identification of helpful and hindering aspects of the session just completed.

INCLUSION/EXCLUSION CRITERIA:

Inclusion criteria:

  1. Pre and post-bariatric surgery patient enrolled at the UHN-BSP who participated in one of four MB-EAT groups in 2015 and 2016.

Exclusion criteria: None.

INTERVENTION: Eight sessions of MB-EAT delivered once per week over the course of 8 weeks, based on a protocol developed by Kristeller et al. with minor modifications to accommodate the typical dietary restrictions encountered by post-surgery patients. For example, due to abdominal discomfort experienced by post-surgery patients when consuming sugar and fat, sugar-free/fat-free food items were made available for mindful eating exercises that involve sweet foods. Each session was two hours in length. The primary emphasis of MB-EAT is to teach and facilitate mindfulness exercises to help participants gain greater control over their eating. Didactics about healthy eating were provided in addition to instruction in a cognitive behavioral therapy exercise that analyzes problem eating episodes. Homework included daily meditations, mindful eating exercises and occasional worksheets.

MB-EAT groups were co-facilitated by two of three clinicians who work in the TWH-BSP: Susan Wnuk, Ph.D., C. Psych., a clinical psychologist; Chau Du, M.Sc., a psychometrist, and Katie Warwick, R.D. a dietitian All facilitators completed MB-EAT facilitator training and provided clinical care in the UHN-BSP for between 5-7 years.

METHOD

  1. Quantitative measures: Participants completed the self-report measures provided by the investigators immediately prior to the start of the first session (baseline) and at the end of the 8th session (week 8).
  2. Qualitative measures: Participants completed the self-report qualitative measure provided by the investigators immediately after the completion of all 8 sessions. Thus, data were collected weekly starting at baseline through to week 8.
Being tested
Mindful eating group
Keywords
mindfulness, overeating, metabolic and bariatric surgery, mindful eating, adults
Medical subject headings
Feeding Behavior, Hyperphagia

What participants receive

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

  • Mindful eating groupBehavioural

    Behavioral group intervention involving 8, 2-hour long sessions

Study groups in NCT07131332
Study groupRoleWhat they receive
Mindful eating groupExperimentalBehavioral group intervention involving 8, 2-hour long sessions
Receives: Behavioral: Mindful eating group

What is being measured

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

  1. Binge Eating Scale

    Self-report questionnaire of eating behaviour typical of binge eating. It contains 16 items and responses for each item range from 1-4. The minimum score is 0 and the maximum score is 46. Higher scores indicate more binge eating.

    Measured: Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later)

Secondary outcomes (5)
  1. Patient Health Questionnaire 9

    Self-report questionnaire of depressive symptoms. It contains 9 items and responses for each item range from 0-3. The minimum total scale score is 0 and the maximum score is 27. Higher scores indicate more depressive symptoms.

    Measured: Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later).

  2. Generalized Anxiety Disorder 7

    Self-report questionnaire of anxiety symptoms. It contains 7 items and responses for each item range from 0-3. Total scale scores range from 0-21. Higher scores indicate more anxiety symptoms.

    Measured: Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later).

  3. Five facets of mindfulness questionnaire

    Self-report questionnaire of traits associated with mindfulness. It contains 39 items and responses on each item range from 1-5. Total scores range from 39-195. Higher scores indicate more mindfulness.

    Measured: Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later).

  4. Multidimensional Assessment of Interoceptive Awareness

    Self-report questionnaire of interoceptive awareness. It contains 32 items and response range from 0-5. The total scale score ranges from 0-185. Higher scores indicate greater interoceptive abilities.

    Measured: Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later).

  5. Helpful Aspects of Therapy Form

    Self-report questionnaire identifying helpful and hindering aspects of the session just completed. It contains 7 main items (1-5) and 4 sub-items (6a, 6b, 7a, 7b) that elicit subjective written responses and numerical ratings. Items 1, 2, 4, 5, 6b and 7b elicit subjective responses about why aspects of the session were helpful or hindering. Item 3 rates the helpfulness of the first identified helpful event on a scale of 0-9: 1=extremely hindering to 9=extremely helpful. Scores range from 1-9. Item 6 asks whether a second helpful event occurred. If yes, 6a rates the helpfulness of the second identified event from 1-4: 1= slightly helpful to 9=extremely helpful. Scores on this item range from 1-4. Item 6b describes what made this event helpful. Item 7 asks whether a hindering event occurred. If yes, item 7a rates the extent from 1=extremely hindering to 4=slightly hindering. Scores range from 1-4. There is no total score computed for this measure.

    Measured: Immediately after the completion of each of 8 MB-EAT sessions from baseline (week 1) and weekly until week 8.

Timeline

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

  1. First posted20 Aug 2025
  2. Study startJun 2015
  3. Primary completionNov 2016
  4. Study completionNov 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07131332
Sponsor's protocol ID
19-5105
Other IDs
19-5105
Status last verified
Aug 2025
First submitted
4 Aug 2025
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Wnuk, S.M., Du, C.T., Van Exan, J. et al. Mindfulness-Based Eating and Awareness Training for Post-Bariatric Surgery Patients: a Feasibility Pilot Study. Mindfulness 9, 949-960 (2018).

  • Chacko SA, Yeh GY, Davis RB, Wee CC. A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial. Complement Ther Med. 2016 Oct;28:13-21. doi: 10.1016/j.ctim.2016.07.001. Epub 2016 Jul 12.

    PubMed 27670865
  • Kristeller JL, Wolever RQ. Mindfulness-based eating awareness training for treating binge eating disorder: the conceptual foundation. Eat Disord. 2011 Jan-Feb;19(1):49-61. doi: 10.1080/10640266.2011.533605.

    PubMed 21181579
  • Goldberg SB, Tucker RP, Greene PA, Davidson RJ, Wampold BE, Kearney DJ, Simpson TL. Mindfulness-based interventions for psychiatric disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2018 Feb;59:52-60. doi: 10.1016/j.cpr.2017.10.011. Epub 2017 Nov 8.

    PubMed 29126747
  • Chesler BE. Emotional eating: a virtually untreated risk factor for outcome following bariatric surgery. ScientificWorldJournal. 2012;2012:365961. doi: 10.1100/2012/365961. Epub 2012 Apr 1.

    PubMed 22566765
  • Rutledge T, Groesz LM, Savu M. Psychiatric factors and weight loss patterns following gastric bypass surgery in a veteran population. Obes Surg. 2011 Jan;21(1):29-35. doi: 10.1007/s11695-009-9923-6. Epub 2009 Jul 15.

    PubMed 19847571
  • White MA, Kalarchian MA, Masheb RM, Marcus MD, Grilo CM. Loss of control over eating predicts outcomes in bariatric surgery patients: a prospective, 24-month follow-up study. J Clin Psychiatry. 2010 Feb;71(2):175-84. doi: 10.4088/JCP.08m04328blu. Epub 2009 Oct 20.

    PubMed 19852902
  • Mitchell JE, Lancaster KL, Burgard MA, Howell LM, Krahn DD, Crosby RD, Wonderlich SA, Gosnell BA. Long-term follow-up of patients' status after gastric bypass. Obes Surg. 2001 Aug;11(4):464-8. doi: 10.1381/096089201321209341.

    PubMed 11501356

Questions about this trial

What is this clinical trial studying?

A study testing Mindful eating group in people with Eating Behaviors, run by University Health Network, Toronto.

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 2 inclusion and 1 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: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Binge Eating Scale (time frame: Immediately prior to the start of the first MB-EAT session (baseline) and at the end of the 8th session (8 weeks later)). 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 NCT07131332, which also lists 8 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 2 Sep 2025.

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