Mindfulness Based Eating Awareness Training (MB-EAT) for Bariatric Surgery Patients: The Effects of Mindfulness on Psychosocial and Physical Functioning
Phase: NA
Conditions: Obesity, Morbid, Eating Disorder Symptom
Sponsor: University Health Network, Toronto

MB-EAT Protocol Version Date: 14-Nov-2016 
 
Mindfulness Based Eating Awareness Training (MB-EAT) for Bariatric 
Surgery Patients: The Effects of Mindfulness on Psychosocial and Physical 
Functioning 
 
Study Protocol: November 14, 2016 
 
 
 
Principle Investigator:  
Dr. Susan Wnuk, Ph.D., C. Psych 
                  
 
 
Psychologist, Bariatric Surgery Program 
                  
 
 
Lecturer, University of Toronto Department of Psychiatry 
                  
 
 
Toronto Western Hospital 
                  
 
 
399 Bathurst Street 
                  
 
 
Toronto, ON M5T 2S8 
                  
 
 
416-603-5800 ext 2186 
 
 
Co-Investigators:  
Katey Park 
 
Chau Du 
Dr. Michelle Dionne 
Wei Wang 
Anna Wallwork  
 
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MB-EAT Protocol Version Date: 14-Nov-2016 
 
Introduction and Rationale: Bariatric surgery is an approved treatment for severe obesity. The 
roux-en-y gastric bypass has been conducted at the Toronto Western Hospital Bariatric Surgery 
Program (TWH-BSP) since late 2009. Given that 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 (Odom et al., 2010), weight regain is of primary concern in this 
population. In one study that followed gastric bypass patients over an average of 28 months, 79% 
regained some weight after reaching their lowest weight, and 15% experienced a weight increase 
of 15% of more from their lowest weight (Odom et al., 2010). Psychiatric factors associated with 
weight regain include binge eating (Mitchell et al, 2001) lack of control over food urges (Odom 
et al., 2010), and a greater number of psychiatric disorders (Rutledge, Goresz & Savu, 2011). 
Obese individuals who pursue bariatric surgery report high rates of problematic eating including 
loss of control over eating, binge eating and chronic overeating (Kalarchian et al., 1998; 
Rutledge, Goresz & Savu, 2011). Even when individuals do not meet criteria for a clinical eating 
disorder, these disordered eating patterns may prevent optimal adherence to post-surgical eating 
guidelines. The first 6 months to 1 year after surgery for most patients is characterized by rapid 
weight loss and patient satisfaction; however, once patients transition from the active weight loss 
phase to weight maintenance, pre-surgery eating problems may recur and lead to weight regain. 
 
Mindfulness meditation techniques may address many of the factors related to disordered eating 
that contributes to weight regain, including negative emotions (Saunders et al., 1998) and 
cognitive distortions (Shook, 2010). Mindfulness training involves purposeful and sustained 
attention to internal dialogues, emotions and bodily cues that encourage recognition and 
toleration of painful emotions in adaptive ways that do not involve problematic behavior like 
eating. Mindfulness is a well-validated intervention for psychological and medical problems in 
other patient populations, including anxiety, depression, stress (Baer, 2003; deVibe et al. 2012; 
Greeson, 2009; Grossman et al. 2004; Hofmann et al. 2010; Khoury et al. 2013) and ruminative 
thoughts (Jain et al., 2007; Shapiro, Brown, & Biegel, 2007). Mindfulness Based Eating 
Awareness Training (MB-EAT) is a group program developed by Kristeller and Hallett (2006) 
that integrates mindfulness meditation and eating meditation with didactics about healthy eating. 
 
Emotion dysregulation is understood to be an important underlying cause of problematic eating. 
In other words, when experiencing painful emotions, individuals with disordered eating tend to 
use overeating or impulsive eating as an avoidance strategy (Beck et al., 2012). Excess calories 
may thus be consumed in an automatic or dissociative manner (Saunders et al., 1998). Repeated 
past diets that teach people to rely on external rules for eating may lead to the loss of one’s 
ability to recognize, accept or respond to internal cues of hunger, taste, satiety, and fullness 
(Heatherton & Baumeister, 1991). Cognitive distortions may also be particularly problematic for 
individuals with problem eating. Beck (1967) defined cognitive distortions as errors in thought 
processes that alter perceptions of reality, often in a manner that reinforces negative thoughts or 
emotions. Shook (2010) found that individuals with poor health habits (such as overeating, 
inactivity, smoking) have higher ratings of cognitive distortions. For example, all or nothing 
thinking, may lead to a “what the hell” effect and ultimately overeating . O’Connor and Dowrick 
(1987) found that individuals who are classified as overweight, typically report more extreme, 
self-defeating food and weight-specific cognitions compared to normal-weight peers. Obese 
individuals reported higher overall ratings on a measure of cognitive distortions surrounding 
rigid weight regulation and fear of weight gain (“If I eat a sweet, it will be converted instantly 

MB-EAT Protocol Version Date: 14-Nov-2016 
 
into stomach fat”) and self-esteem  (“If my weight goes up, my self-esteem goes down”). A 
study conducted by Sears and Kraus (2009) found that a reduction in cognitive distortions 
mediated the intervention effects for reducing anxiety, negative affect, and promoting hope for 
college students.  
 
The body of research evidence for mindful eating interventions is small but promising. A recent 
review concluded mindfulness approaches can improve outcomes in persons with eating 
disorders and is also associated with a reduction in overall food consumption, healthier food 
choices, and practices that slow the eating process (Ganley, 1989). Kristeller and Hallett (1999) 
in their application of MB-EAT to women with binge eating disorder, found a significant 
improvement in participants’ perceived control of eating and awareness of hunger and satiety 
cues. In a pilot study of a mindful eating group for obese adults patients reported significant 
increases in mindfulness and restraint over eating, and significant decreases in weight, binge 
eating, and negative affect (Dalen et al., 2010). Leahey et al. (2008) integrated mindfulness into 
cognitive behavioural therapy for post-bariatric surgery patients and found improvements in 
eating, emotion regulation, and depression. Wnuk et al. completed a small, unpublished 
feasibility study (n=28) of MB-EAT with post-bariatric surgery patients at the TWH-BSP 
between 2014-2015. Preliminary non-parametric analyses (chosen because of the small sample 
size), revealed statistically significant improvements from pre to post-MB-EAT in depression 
(z=.01) and emotion regulation (z=.02) and noticeable improvements in means for emotional 
eating (p=.07). In addition, participants rated the helpfulness of each session highly on a 7-point 
scale, with 7 indicating ‘completely helpful’, between 5.67/7 (after the first session) to 6.18/7 
(after the 8the session). Ratings increased steadily over the course of the treatment. A manuscript 
for publication is currently being prepared.  
 
There are limitations to this research that the proposed study attempts to address. Except for the 
study by Leahy at al. and Wnuk et al, mindful eating studies have been conducted with non-
bariatric surgery patients. Leahy et al’s (2008) study included only seven patients who ranged 
from two to 11 months post-surgery, making it very difficult to generalize to other bariatric 
surgery patients. In addition, their treatment was created specifically for their study and appears 
to be largely CBT-based, making it difficult to conclude whether changes observed were due to 
the CBT or mindfulness intervention. Finally, in a recent review psychotherapeutic and support 
group were been associated with greater weight loss post-bariatric surgery, though specific 
modalities were not found to be more effective (Beck et al., 2012). 
 
Objectives and Hypotheses:  
Purpose of Study: This study is to examine the effectiveness of MB-EAT in enhancing 
psychosocial functioning as an adjunctive treatment to the usual standard of care in bariatric 
surgery patients.  Participants will receive MB-EAT 6 months or more following bariatric 
surgery. Participants will be randomly assigned to receive MB-EAT one week or 8 weeks 
following consent. Individuals in the group starting in 8 weeks will serve as a waitlist control 
group.       
 
The primary objective of this study is to examine whether MB-EAT is an effective and feasible 
adjunctive treatment to the usual standard of care.   

MB-EAT Protocol Version Date: 14-Nov-2016 
 
Outcome Measures: The primary outcome measures will be changes in self-reported eating 
pathology, depression, anxiety, and mindfulness.  See measures in Appendix.  
 
Hypothesis: 
 
1. MB-EAT will lead to significantly greater improvements in eating pathology, depression, 
anxiety, emotion regulation, cognitive distortions, body image dissatisfaction and 
mindfulness as compared to the wait list control group. 
 
Methods 
Study design: A pre-post treatment design will be used with a waitlist control. Upon completion 
of the introductory session, participants will be randomly assigned to either the first or second 
MB-EAT group. Participants in the second group will act as the waitlist control and complete the 
pre and post questionnaires simultaneously with the first group. There will be a follow-up at 6 
months and 12 months to establish stability of symptoms post-intervention.  
 
Participants: Participants (N = 72; 12 per group) will be recruited from the Bariatric Surgery 
Program at Toronto Western Hospital.  All bariatric surgery candidates who meet the study 
inclusion/exclusion criteria will be eligible for participation. Six separate groups of 12 
participants per group will be run.  
 
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). 
 
Participants will be screened for eligibility over the phone by administering the PHQ-9 
(depression) and GAD-7 (anxiety) verbally. This screening will be completed once the 
participant has expressed interest in participating, prior to attending the first session. Of note, 
patients in the Bariatric Surgery Program who have active suicidal ideation, serious mental 
illness, severe depression, or severe anxiety do not receive bariatric surgery until their 
psychiatric symptoms stabilize.  Thus, the vast majority patients who are currently post-bariatric 
surgery will be eligible for participation in this study.  In the event that participants develop 

MB-EAT Protocol Version Date: 14-Nov-2016 
 
significant mental health issues (e.g., active suicidal ideation, serious mental illness) during the 
research study, a consultation will be arranged with one of the staff psychiatrists in the program.  
 
Treatment: Participants will receive one introductory information session about the 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 an approach to eating designed 
to change their relationship with food and improve their decision making abilities in regards to 
food, through a variety of mindful eating practices and guided mindfulness meditations. 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. Participants 
will also receive weekly take-away documents, which may include: (1) key information from the 
session; (2) relevant articles; (3) poems; (4) homework exercises. All participants will continue 
to receive the routine standard of care provided to all patients of the TWH-BSP while 
participating in the study. 
 
Both MB-EAT groups will be 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. All facilitators have completed MB-EAT training with J. Kristeller (the 
primary developer of MB-EAT) and A. Lieberstein (a clinician with extensive experience 
facilitating MB-EAT) and have provided clinical care in the TWH-BSP for between 4-6 years. 
Susan Wnuk and Chau Du have clinical experience with mindfulness and eating disorders and 
extensive clinical experience with mindfulness-based interventions. Susan Wnuk and Chau Du 
will supervise the research assistant.  
 
Procedure: Of the 3977 patients currently enrolled in the TWH-BSP, 28% reside within 20 km, 
yielding an estimated 1114 patients who could potentially be recruited during the course for the 
proposed study. Patients will be recruited through the following means, which were successfully 
employed during 2014-2015 feasibility study (REB protocol #13-7006-BE):  
1. Flyers will be posted in the Bariatric Surgery Department with contact information for 
the study investigator. Patients who are interested in participating can self-refer and 
contact the investigator directly, who will address the potential participant’s questions 
and arrange to obtain signed consent, if applicable. 
2. Announcements will be made at the twice monthly TWH-BSP patient support group for 
the duration of the recruitment phase. Announcements will be made by study staff or a 
member of the TWH-BSP to the group of assembled patients (usually 30-40 patients per 
support group). Staff members take turns facilitating and organizing support group 
sessions. The following script will be used to make the announcement: “We are currently 
recruiting patients who are six or more months post-bariatric surgery for a study on a 
mindful eating group called ‘Mindfulness Based Eating Awareness Training.’ The group 
is 8 weeks long and there are up to 10 participants per group. The purpose of the group 
is to see if it helps patients become more aware of their eating patterns and triggers for 
unhealthy eating behaviours, and to learn skills for managing these. If you’re interested, 
please take one of the flyers (i.e. MB-EAT recruitment flyer) and contact the study staff 
listed on it. You can also write your contact information on the form provided (i.e. MB-
EAT recruitment form) if you’d prefer to have a study staff person contact you” 

MB-EAT Protocol Version Date: 14-Nov-2016 
 
3. When patients who are six months or more post-surgery attend their routine follow-up 
assessments at the TWH-BSP as the standard of care, TWH-BSP clinicians will inform 
them of the study using the script provided above. Study staff will ensure that these 
clinicians are provided sufficient copies of the MB-EAT recruitment flyer and 
recruitment form. They will provide the potential participant the MB-EAT recruitment 
flyer and/or ask the potential participant to provide their contact information on the MB-
EAT recruitment form. Other clinicians in the patient’s circle of care who are outside of 
the TWH-BPS such as family physicians or specialists, will not be involved in 
recruitment. 
 
A research assistant will collect MB-EAT recruitment forms and contact patients by phone who 
express interest in participating to explain the study. The research assistant will describe the 
study (i.e., the information covered in the study consent form) and answer any questions 
potential participants might have. Consent will be obtained at the introductory information 
session. Ample time will be given prior to the commencement of the session so that potential 
participants have an opportunity to review it before consenting to take part in the research study.  
 
Mindfulness-Based Eating and Awareness Training (MB-EAT): Eight sessions of 
Mindfulness Based Eating and Awareness Training (MB-EAT) will be 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 will be made available for mindful eating 
exercises that involve sweet foods. The primary focus of treatment is the use of general 
mindfulness meditation and eating meditation to help participants bring greater awareness and 
understanding to their relationship with food. One introductory information session will be 
offered prior to the start of the 8-session MB-EAT protocol. The purpose of this information 
session is to explain the intervention and expectations for participation. It will be facilitated by 
the leaders of the 8 week protocol. Homework consists of weekly mindfulness exercises. Many 
of these exercises involve listening to an audio recording of a guided meditation, which will be 
emailed to participants. Since email will be used throughout the study for contact purposes, a 
separate consent form for email communication for the study will be administered. If participants 
do not have email they will be provided a data key loaded with the mindfulness exercise audio 
recordings. 
 
Taped Sessions: For the purpose of supervision and also as a measure of adherence to the MB-
EAT protocol, all sessions will be audiotaped. The sessions will be reviewed for adherence to the 
protocol, according to a checklist that outlines the main goals of each session and to ensure inter-
rater reliability between therapists. 
 
Assessment: Participants will be administered measures pre-treatment, post-session, post-
treatment and six months and one year post-treatment. 
 
Measures: 
Pre-Group Only (please see attached) 
Demographics: Age, gender, ethnicity, education, work status, marital status. 

MB-EAT Protocol Version Date: 14-Nov-2016 
 
 
Pre, Post and Follow-up Measures (please see attached) 
Pre-treatment questionnaires will be completed during the first information session, and post-
questionnaires will be completed during the last MB-EAT session. Follow-up questionnaires will 
be completed during regular standard of care clinical visits if feasible, or a separate appointment 
will be made with participants for the purpose of completing questionnaires, or they will be 
mailed questionnaires with sufficient return postage 
 
Anthropometric and Physical measures: Anthropomorphic (height and weight) and physiological 
measurements (blood pressure measured by mm Hg, taken using standardized measurement 
techniques and validated electronic upper arm blood pressure monitors) will be obtained at the 
TWH-BSP by Wei Wang, a TWH-BSP nurse practitioner and co-investigator. Gastrointestinal  
symptoms will be assessed by Wei Wang using a clinician-administered rating scale, the 
Gastrointestinal Symptom Rating Scale. 
 
 
Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001). The PHQ-9 is a 9-item self-report 
measure of depression severity.  Respondents are asked to rate the frequency with which they 
have experienced depressive symptoms over the last two weeks on a scale ranging from 0 (not at 
all) to 9 (nearly every day).  Scores on the PHQ-9 can range from 0 to 27, and mild, moderate, 
moderately severe, and severe levels of depressive symptoms correspond to cut-off scores of 5, 
10, 15, and 20 respectively. 
 
Generalized Anxiety Disorder Questionnaire (GAD-7; Spitzer et al., 2006). The GAD-7 is a 7-
item self-reported measure of anxiety severity.  It was originally developed to diagnose 
generalized anxiety disorder, but it has also proved to be a good screening instrument for other 
disorders including panic disorder, social phobia, and post-traumatic stress disorder.  
Respondents are asked to rate the frequency with which they have experienced anxiety 
symptoms over the last two weeks on a scale ranging from 0 (not at all) to 9 (nearly every day).  
Scores on the GAD-7 can range from 0 to 21, and mild, moderate, and severe levels of anxiety 
symptoms correspond to cut-off scores on 5, 10, and 15 respectively.    
 
The Three Factor Eating Questionnaire –R18 (TFEQ-R18; de Lauzon et al., 2004). The TFEQ-
R18 is an 18 item measure developed in an obese population to investigate 3 aspects of eating 
behaviour: cognitive restraint, uncontrolled eating, and emotional eating.  
 
 
Five Facets of Mindfulness Questionnaire (FFMQ; Baer et al, 2006). The FFMQ is a 39-item 
self-report measuring mindfulness on five scales: Observing, Describing, Act with Awareness, 
Nonjudging, and Nonreactivity. .  
 
Self-Compassion Scale (SCS; Neff, 2003). The SCS is a 26-item measure tapping self-kindness, 
self-judgment, common humanity, isolation, mindfulness, and over-identification. Participants 
respond to various items about ‘‘how I typically act toward myself in difficult times’’ on a 5-
point scale, with higher total scores indicating greater self-compassion. 

MB-EAT Protocol Version Date: 14-Nov-2016 
 
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004). The DERS is a 36 
item questionnaire that measures general difficulties in emotion regulation. Items are rated on a 5 
point scale with higher scores indicating better emotion regulation. Six subscales are computed: 
nonacceptance of emotional reactions; difficulties engaging in goal directed behaviour; impulse 
control difficulties; lack of emotional awareness, and limited access to emotion regulation 
strategies.   
Body Parts Satisfaction Scale (BPSS; Berscheid et al., 1973). The original BPSS is a 23-item 
measure that assesses satisfaction on a 6-point Likert scale (“extremely satisfied, somewhat 
satisfied, somewhat dissatisfied, quite dissatisfied, extremely dissatisfied”) on individual body 
parts (i.e., hips, teeth, etc.). The present scale is a modified version that eliminates unrelated 
items (i.e., size of sex organs) in order to relieve patient burden. Additionally, there is one added 
question assessing satisfaction with loose skin, which is a common concern for post-bariatric 
surgery patients. 
Body Satisfaction Questionnaire (BSQ; Cooper at al., 1987). The BSQ is a valid and reliable 
measure that assesses body shape concerns and body dissatisfaction. The scale asks participants 
to indicate on a 6-point Likert scale the subjects state over the past 4 weeks (“never, rarely, 
sometimes, often, very often, always”). 
The Dichotomous Thinking Scale (DTS; Byrne et al., 2008) The DTS is a 16-item scale that 
measures the cognitive distortion of dichotomous, or “black and white,” thinking. Six items are 
specifically surrounding cognitive distortions related to food, dieting, and weight, while the 
remaining ten items more broadly measure dichotomous thinking. 
The Obesity Cognitions Scale; O’Connor et al., 1987) The Obesity Cognitions Scale is a measure 
of 15 items that measures cognitive distortions surrounding food, weight, and shape that are 
more typical for individuals classified as obese.  
Gastrointestinal Symptom Rating Scale (GSRS); Svedlund et al., 1988). The GSRS is a 15 item 
clinician administered scale that assesses a variety of symptoms on a point likert scale to assess 
severity of symptoms. The scale has been shown to be useful in comparing the effectiveness of 
treatments in previous clinical trials.   
 
Group Session Evaluation Questionnaires (please see attached) 
Helpfulness of session just completed. This is a one item questionnaire developed for this study 
to evaluate participants’ overall rating of the session.  
Homework Monitoring Form. Participants record how many days per week and minutes per day 
they practiced their mindfulness homework. This item was developed for this study. 

MB-EAT Protocol Version Date: 14-Nov-2016 
 
Working Alliance Inventory-Short Form (WAI-short form; Tracey & Kokotovic, 1989) – The 
WAI-short form is a 12-item self-report measure that assesses the alliance between patient and 
therapist.  Respondents are asked to rate the frequency with which they feel each statement 
describes the alliance they have with their therapist on a scale from 1 (never) to 7 (always).  The 
WAI consists of 3 subscales reflecting goals, bond, and tasks. 
Group Climate Questionnaire (GCS; MacKenzie, 1983). The GCS is a 12-item self-report 
measure that assesses the degree to which participants feel the group has a positive atmosphere 
and constructive interpersonal interactions. It includes 3 subscales: engagement, avoidance and 
conflict and items are rated on a scale from 0 (not at all) to 6 (extremely). 
Post-Group Individual Participant Interview (please see attached).  
The Client Change Interview (Elliott et al., 2001). The Client Change interview is an hour-long 
semi-structured interview. The major topics of this interview are any changes patients have 
noticed since therapy began, what you believe may have brought about these changes, and 
helpful and unhelpful aspects of the therapy. The main purpose of this interview is to allow 
patients to tell us about the therapy and the research in their own words. This information will 
help researchers to understand better how the therapy works; it will also help us to improve the 
therapy. This interview is audio-recorded for later transcription.  
 
 
 
 
Assessment Timeline: 
 
Measure 
Baseline 
Sessions 1 
to 8 
Post-
Treatment 
 
6 & 12 Months 
Post 
Treatment 
Demographics  
X 
 
 
 
Anthropomorphic Measures 
X 
 
X 
X 
Patient Health Questionnaire 
X 
 
X 
X 
Generalized Anxiety Disorder 
Questionnaire 
X 
 
X 
X 
 
 
 
 
 
Three Factors of Eating 
Questionnaire Revised-18 
X 
 
X 
X 
Emotional Eating Scale 
X 
 
X 
X 
Five Facets of Questionnaires 
X 
 
X 
X 
Self-Compassion Scale 
X 
 
X 
X 
Difficulties in Emotion Regulation 
X 
 
X 
X 

MB-EAT Protocol Version Date: 14-Nov-2016 
 
Scale 
Personal Questionnaire 
X 
 
X 
X 
Body Parts Satisfaction Scale 
X 
 
X 
X 
Body Satisfaction Questionnaire 
X 
 
X 
X 
Obesity Cognitions Scale 
X 
 
X 
X 
Dichotomous Thinking Scale 
X 
 
X 
X 
Helpfulness of Session 
 
X 
 
 
Homework Monitoring Form 
 
X 
 
 
Working Alliance Inventory 
 
X 
 
 
Group Climate Questionnaire 
 
X 
 
 
The Change Interview 
 
 
X 
 
 
Statistical Analysis: Analysis of variance will be conducted in the case of continuous variables, 
and chi square analyses will be conducted in the case of categorical variables to compare the 
groups on demographic and baseline clinical variables.  If there are significant differences 
between groups on demographic or clinical variables measured at baseline, or on session 
measures, these variables will be entered as covariates in the statistical analyses.  A repeated 
measures analysis of variance will be conducted to compare the groups on each of the outcome 
variables and Cohen's effect sizes will be computed for each of the primary outcome variables.   
 
Privacy and Confidentiality: E-mail correspondence will be sent from a secure UHN e-mail 
account.  Participants will be notified that security and confidentiality of information cannot be 
guaranteed through e-mail correspondence.  All rating scales and forms used at each assessment 
will use a single coding system, with only the research ID number and study name written on it.  
Personal health information is required for determining participant eligibility for the study and to 
contact the participant during the study for MB-EAT sessions.  The master code will be kept by 
the research coordinator for the duration of the study and will be kept separately from the 
research data (i.e., participant files).  Contact information will be used throughout the course of 
the study and correspond to the master code.  All data and personal health information will be 
stored in a locked room in a locked cabinet.  Contact information, demographic data, and 
computerized rating scales will be stored on a password-protected computer on a secure network 
drive.  A login name and password will be required to access these files and the computer will be 
located in a locked office.  Similarly, audio recordings of MB-EAT sessions will be stored on 
these password-protected computers on a secure network drive in a locked office. Participants 
will be referred to by their first names only in the audio tapes and participants will be advised not 
to disclose any personal identifying information during the recording to further maintain their 
privacy. Only individuals involved in the research project will have access to these tapes and all 
data will be destroyed after 5 years.  
In the event of inappropriate release of personal health information, after further release of 
information is stopped and any information that could be retrieved is retrieved, the UHN Privacy 
Office and REB will be notified. Then, further actions on informing participants might be taken 
according to recommendations from the UHN Privacy Office and REB. 
Risks Related to being in the Study: There are no known risks associated with receiving 
Mindfulness-Based Eating and Awareness Training. Participants will be asked to reflect upon 

MB-EAT Protocol Version Date: 14-Nov-2016 
 
some personal issues and their psychological health (e.g., eating habits, mood, anxiety, quality of 
life) during Mindfulness-Based Eating and Awareness Training and while completing the 
questionnaires.  They may choose to discontinue Mindfulness-Based Eating and Awareness 
Training or to refuse to answer questions at any time if they experiece discomfort. 
Benefits to being in the Study: There is some evidence that Mindfulness-Based Eating and 
Awareness Training is effective in improving eating habits, depression, and emotional eating for 
individuals with binge eating and after bariatric surgery. Participants may or may not receive any 
direct benefit from being in this study.  Information learned from this study may help other 
bariatric surgery patients in the future.   
 
Implications: If MB-EAT is found to be effective with bariatric surgery patients and is feasible 
to deliver, the treatment could become the standard of care in the Bariatric Surgery Program at 
Toronto Western Hospital. In addition, the Toronto Western Hospital MB-EAT protocol could 
be used to deliver MB-EAT to bariatric centers across the province and perhaps beyond, thus 
providing cost-effective psychosocial care. 
 
Conflicts of Interest: There are no known conflicts of interest. 
 

MB-EAT Protocol Version Date: 14-Nov-2016 
 
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