Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-01 @ 2:27 AM
Study NCT ID:
NCT07131332
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness-Based Eating Awareness Training for Post-bariatric Surgery Patients
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Mindfulness Based Eating and Awareness Training for Post-bariatric Surgery Patients: A Mixed Methods Outcome Study
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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?
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
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?
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
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 19-5105 | OTHER | University Health Network | View |