An interventional study of Mindful eating group in Eating Behaviors, sponsored by University Health Network, Toronto. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
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:
Participants were asked to:
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
218 studies on the registry are indexed under Feeding Behavior; 95 are open to participants now.
This study's enrollment of 45 is below the median of 75 across 161 interventional studies indexed under Feeding Behavior.
Browse Feeding Behavior studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Exclusion Criteria:
- Inability to speak, read and write English
Behavioral group intervention involving 8, 2-hour long sessions
Behavioral: Mindful eating group
Behavioral group intervention involving 8, 2-hour long sessions
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.
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)
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.
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).
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.
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).
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.
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).
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.
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).
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.
Time frame: Immediately after the completion of each of 8 MB-EAT sessions from baseline (week 1) and weekly until week 8.
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto