Targeting Maladaptive Eating Behaviors With Mindfulness-based Training to Prevent Weight Regain
Phase: NA
Conditions: Weight Loss, Weight Gain, Eating Behavior, Obesity, Bariatric Surgery Candidate
Sponsor: University of Utah

Title: Targeting Maladaptive Eating Behaviors with Mindfulness-Based Training to Prevent 
Weight Regain 
NCT Number: NCT04847843 
Document Date: 06/29/2023 
 

Protocol Summary (ERICA) 
 
IRB_00132961 
Page 1 of 7 
 
IRB Approval 6/29/2023 
 
 
Targeting maladaptive eating behaviors with 
mindfulness-based training to prevent weight regain  
 
Protocol Summary 
 
 
 
IRB Approval 
Date of 
Current 
Version: 
6/29/2023 
University of 
Utah IRB #: 
IRB_00132961 
Sponsor: CTSI - CLINICAL TRIALS SUPPORT 
NIH NATL CTR FOR ADVNCING TRANSLT SCNCES 
  
Principal 
Investigator: 
Tanya Halliday 
Internal Staff 
and  Sub-
Investigators: 
Site Name 
Staff Names 
University of Utah Tanya Halliday 
 
Grace Zimmerman 
 
Tanya Halliday 
 
Selene Tobin 
 
Isaac Ou 
 
Victoria Miranda 
 
This document was created using the ERICA Online System at the University of Utah. The document is created 
from study information approved by the IRB on the date listed above.  Any alteration to the original content of this 
document may not be considered to represent the study as approved by the IRB.  
 
 

Protocol Summary (ERICA) 
 
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IRB Approval 6/29/2023 
 
Background and Introduction 
 
Over 70% of adults in the United States have overweight or obesity (CDC, 2017), which is causally linked to the 
development and progression of multiple adverse health outcomes (Allison et al., 2008). Weight loss 
interventions using lifestyle strategies or pharmacotherapy produce clinically meaningful reductions in body 
mass (Expert Panel, 2014; Magkos et al., 2016). However, due to complex physiological, neuronal and reward-
related behavioral process that seek to restore homeostasis(Allison et al., 2008; CDC, 2017; White, Whisenhunt, 
Williamson, Greenway, & Netemeyer, 2002), maintaining weight loss is challenging and weight regain is common 
(Hill, Peters, & Wyatt, 2009; Maclean, Bergouignan, Cornier, & Jackman, 2011; MacLean et al., 2015). Due to 
the high likelihood of weight regain, identification of effective strategies to promote weight maintenance 
following intentional weight loss is a high priority in the obesity field. Furthermore, it is crucial that 
interventions be cost-effective and feasibly integrated in to existing health-care systems in order to have a 
broad impact on the long-term health of US adults. Mindfulness-based interventions are novel approaches that 
could be well suited for weight loss maintenance due to their success in treating other chronic conditions and 
behaviors with high relapse susceptibility, such as depression and drug/alcohol addiction (Goldberg et al., 
2018). Recently, Dr. Eric Garland (Co-I) demonstrated that his previously developed Mindfulness-Oriented 
Recovery Enhancement (MORE) intervention(E. Garland, 2013), which has been shown in multiple NIH-funded 
randomized clinical trials to significantly reduce a range of addictive habits, is effective at reducing 
maladaptive eating behaviors in adults with obesity (Thomas et al., 2019). MORE is unique from other existing 
mindfulness based interventions as it combines traditional mindfulness training with cognitive reappraisal and 
savoring strategies to promote adaptive reward system function. Due to its comprehensive approach and 
demonstrated therapeutic effects on physiological, neuronal and reward-related mechanisms linked with 
appetitive behaviors, MORE may be an effective intervention for preventing weight regain. Preliminary data 
from an ongoing trial in my laboratory with an 8-week mindfulness-based intervention (Halliday & Cornier, 
unpublished data) indicates that weight regain is minimal (-0.04±1.2% of body weight) and that participants 
(n=7) report high satisfaction (average sores >9 out of 10 for content and weight-loss maintenance) with the 
intervention. However, to date, no randomized trial has evaluated the efficacy of MORE for preventing weight 
regain, nor have the long-term effects of mindfulness-based interventions on weight loss maintenance been 
investigated. 
 
 
 
Purpose and Objectives 
 
The overall objective of this study is to evaluate the effectiveness of a mindfulness-based 
intervention to prevent weight regain in weight-reduced adults. 
A secondary objective is to perform preliminary efficacy testing comparing the impact of MORE 
vs standard weight loss maintenance advice (CON) on weight loss maintenance and eating-
related behaviors (disinhibition, hedonic hunger, food cravings, and ad libitum energy intake). 
To meet these objectives, we propose the following aims: 
Specific Aim 1: Determine the effect of MORE on weight loss maintenance. 
Hypothesis:  MORE will result in less weight regain compared to CON after the 8-week 
intervention, and benefits will be sustained in a 6-month follow-up. 
Specific Aim 2: Determine the effect of MORE on reward-related behavioral processes (e.g., 
food cravings) and ad libitum energy intake. 
Hypothesis: MORE group will demonstrate changes in eating behaviors and energy intake 
associated with preventing weight regain compared to CON immediately after MORE and after 6-
months of follow-up. 

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Study Population 
 
Age of Participants: 18-65 
 
Sample Size: 
At Utah: 
  
All Centers: 
100 
 
Inclusion Criteria: 
We will enroll the following three subgroups (ages 18-65 years): 
• Lifestyle weight loss: weight loss of 7% body mass via intentional weight loss within 
past 6 months; BMI >25 kg/m2 prior to intentional weight loss. 
• Medical weight loss patients: patients of the bariatric weight loss clinic, weight loss of 
7% body mass via intentional weight loss within past 6 months; BMI >25 kg/m2 prior to 
intentional weight loss; stable for 3 months on medications. 
• Bariatric Surgery patients: 12-20 months post-operation. 
 
 
Exclusion Criteria: 
Exclusion Criteria: uncontrolled cardiovascular, metabolic, renal, or pulmonary disease; 
cancer treatment in past 5 years; untreated thyroid disease or other medical condition 
affecting weight or energy metabolism; severe food allergies; women who are pregnant, 
lactating, or planning pregnancy during participation in the trial; active psychiatric issues. 
Scheduled bariatric surgery within the next 6 months. No access to WiFi at residence. No 
access to a smart device as a personal device (with access to applications). Complete hearing 
loss. 
Additional criteria specific to patients with a history of bariatric surgery: <12 months post-op; 
weight regain of >5% of body mass post-operation; history of admittance to rehabilitation 
facility; history of post-op complications that require recent inpatient management; patients 
who were required to stay in the hospital >1 week post-op; revision surgery patients; heart 
failure patients. 
Additional criteria specific to lifestyle and medical weight loss participants: Bariatric 
surgery within the past 2 years 
 
 
Design  
 
Randomized Trial 
 
 
 

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Study Procedures 
 
Recruitment/Participant Identification Process: 
• Chart Review  
o Participants will be recruited from the Electronic Health Record (EHR) in the UU 
Health system. Participants meeting initial criteria will be contacted via email or 
opt-out letter, inviting them to complete a medical history screening survey over 
the phone with a member of the research team to further determine eligibility. 
We will also recruit via passive techniques (i.e. fliers in campus, clinics, and 
community locations; newspaper and social media ads). 
• Referral  
o Physicians at University of Utah Health primary care clinics will be able to refer 
eligible patients from their clinical practice to the study. Clinics will either 
be provided with a simple referral form that patients can complete if 
interested.  
o Surgeons at The Bariatric Surgery clinic at University of Utah will also refer 
patients to this study. A Study coordinator will be in clinic to provide study 
information and enroll referred patients who may be interested in participating.  
• Flyers   
o Flyers will be placed on campus and in community centers. Flyers will also be 
sent out electronically via University of Utah email lists. Advertisement flyers 
will also be posted on relevant University of Utah research-related websites. 
• Follow-Up  
o PI or research assistant will follow up via phone or email (using the 
selene.tobin@utah.edu account) once an individual has expressed interest in the 
study from one of the recruitment techniques. No more than 3 contact attempts 
will be made. 
 
 
Informed Consent: 
Description of location(s) where consent will be obtained:  
Consent will be obtained in: - a private room in the HPR complex - a private room in the 
Bariatric Surgery Clinic - over a private HIPPA compliant Zoom session (e-consent)  
 
Description of the consent process(es), including the timing of consent:  
Informed Consent will be completed in person, or over a private HIPAA compliant Zoom call, 
with a member of the study team and the potential participant. During the explanation of the 
consent form and after the study team member goes over the details of the Informed Consent 
document, the potential participant will be given a chance to ask questions regarding study 
procedures. The study team member will assess understanding of the consent form and study 
procedures by asking the potential participant to briefly recite back study-related commitments 
and procedures. Potential participants will be told that they are free to take the consent form 
home with them and decide to sign it and participate in the study at a later time if they are 
uncomfortable with consenting to the study during this visit. In addition, to provide 
participants with greater time between seeing the consent form and signing it, the consent form 
will be emailed to participants, and available to them via REDcap, prior to the screening visit 
so that they can view it on their own time 1-year follow-up visit addition to study: As of 
March 2023, participant enrollment will be over. At that time, participants who are still in 

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ongoing data collection (have not completed the six month follow up visit), will be contacted 
and asked to sign a new consent document ("Informed Consent Document_v.03.13.23_Clean") 
that outlines one additional contact event at 1 year (6 months following the 6 month study 
visit). At this time, participants who have formally completed their data collection (have 
completed the six-month follow-up visit), will be contacted via email (2 contact attempts) and 
phone (1 contact attempt; for a total of 3 contact attempts) and will be asked if they have 
interest in enrolling in the study for the 1 year follow up contact event. These participants will 
be provided a copy of the consent document they previously signed, and they will be provided 
a new consent document outlining this additional study event (One Year Follow-up Informed 
Consent Document_v.03.13.23_Clean). If they would like to participate in the 1 year follow 
up they will be asked to sign the new consent document. These specific changes are being 
done so that participants who are currently enrolled in the study can simply sign an updated 
consent document to participate in the 1 year follow up event. And participants who are no 
longer in contract with the original informed consent document can opt-in to this new study 
event with a simplified consent document. All processes followed in obtaining the initial 
consent that are explained above will be followed.  
 
Procedures: 
PRE-SCREENING: Subjects who are interested in participating with undergo a pre-screening in which they will 
answer questions over Redcap, or via a phone screening with trained study staff, about their medical history and 
they will be assessed on all inclusion and exclusion criteria. 
SCREENING: After pre-screening, interested participants that remain eligible will be scheduled for a Zoom 
screening visit to determine eligibility. After providing written informed consent, participants of childbearing 
potential will perform a pregnancy test that will be delivered to their home. Upon completion of a pregnancy test 
participants will be asked to report the results over Zoom. Participants will also be asked to remotely complete the 
EATS-26 questionnaire (Garner, Olmsted, Bohr, & Garfinkel, 1982) to screen for eating disorder risk, The Patient 
Health Questionnaire 9-Item (PHQ-9)(Kroenke, Spitzer, & Williams, 2001) to screen for depression, and 
the Alcohol Use Disorders Identification Test (AUDIT)(Daeppen, Yersin, Landry, Pécoud, & Decrey, 2000) to 
screen for alcohol use disorders via REDcap. Participants that remain eligible and are willing to participate in the 
trial will complete the following assessments: 
BASELINE TESTING:  
• Body Mass, Height, and Composition via digital scale, stadiometer, and BodPod (air 
displacement plethysmography) 
• Validated Eating-Related Behavioral Questionnaires to assess dietary restraint, disinhibition and 
hunger (Three Factor Eating Questionnaire); diet-specific self-efficacy (Weight Efficacy Lifestyle 
Questionnaire); and food cravings (Food Craving Inventory; FCI); Interoceptive 
Awareness (Multidimensional Assessment of Interoceptive Awareness; MAIA); and savoring (Ways of 
Savoring Checklist)  
• Free-living Energy Intake (EI) via automated 24-hr dietary recall (ASA-24) administered online through 
the Clinical Services Core of the CCTS. This recall will be administered on 3 non-consecutive 
days,including 2 weekdays and 1 weekend day. 
• Meal Test: Participants will also complete a baseline meal test visit for assessment of appetite-related 
markers. Participants will be asked to keep a 1-day food log the day before this testing visit at baseline 
and asked to repeat this same meal pattern the day before the post-intervention testing visit. Participants 
will present to the Human Performance Laboratory in the morning after an overnight fast and having 
refrained from exercise for the prior 48-hours. Participants will next consume a standard breakfast meal 
(25% of the total energy needs).  Repeat appetite evaluations will be performed at 30, 60, 90, 120, 150, 
and 180 minutes post-meal. Participants will then be offered a buffet-style lunch to measure ad 
libitum energy intake 

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• Randomization: Following enrollment and completion of baseline testing a randomization assignment 
will be generated by computer and block randomization will be performed within strata defined by sex. 
Participants will be randomized 1:1 to MORE or CON 
INTERVENTION: 
Group-Based Interventions 
• MORE: Participants randomized to MORE will complete the previously developed 8-week, 
MORE program (E. Garland, 2013). MORE is delivered in a group format, consisting of 8 weekly HIPPA 
compliant virtual zoom 2-hour sessions. The MORE curriculum will be adapted for this intervention to 
address food intake behaviors and will provide training in mindfulness techniques to increase awareness 
of, and self-control over, cravings; reappraisal skills to promote emotion regulation and restructure 
motivations for highly palatable food intake; and savoring pleasant events and emotions to overcome 
defects in natural reward processing. In addition to class sessions, participants will complete daily, 15-
minute, audio-guided mindfulness, reappraisal, and savoring sessions at home. The intervention will be 
delivered by a study team member who will receive training and supervision from Dr. Garland. Treatment 
fidelity will be monitored as in ongoing RCTs of MORE (E. L. Garland, Manusov, et al., 2014).  
• CON: Participants randomized to the control intervention will complete an 8-week healthful lifestyle 
program via HIPPA compliant zoom sessions. The curriculum will be based on the Diabetes Prevention 
Program’s Prevent T2 for Life program, which is an evidence-based national healthful lifestyle 
maintenance intervention. This program includes training in healthful eating, meal planning, and recipe 
modification; time and stress management; adapting lifestyle habits for continued success during 
holidays, vacations, and other special situations; and relapse prevention. CON will be virtually delivered 
by a study team member who will receive training and oversight from Dr. Halliday, who has delivered this 
intervention previously. In addition to class sessions, participants will be completed daily, 15-minute 
activities related to the course content (i.e. – designing a meal plan and grocery shopping list; creating a 
list of healthful take-out or restaurant meals; etc) at home. Time-in-treatment will be matched between 
conditions. 
  
  
  
  
POST-INTERVENTION TESTING: Repeat baseline testing at the end of 8 weeks and at 6 months. 
OPTIONAL POST-INTERVENTION TESTING AT 1 YEAR: 6 months after the post-
intervention testing time point participants will be contacted and asked to complete follow-up 
questionnaires. These questionnaires are designed to assess participants' perceptions of the 
intervention and if they achieved their weight-loss maintenance goals. 
STOPPING PROCEDURES and ADVERSE EVENTS: Participants will be encouraged to report any adverse 
events that they believe may have been a result of the study. 
  
  
  

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Procedures performed for research purposes only:  
 
 
Statistical Methods, Data Analysis and Interpretation 
 
The statistical analysis plan presented below was developed in collaboration with Dr. Jincheng 
Shen of the SDBC. 
Aim 1 will focus on the efficacy of the intervention (MORE vs. CON) on the primary outcome of 
body mass and body composition at week 8 and week 24. We will first provide descriptive 
summaries of each variable measured at week 0 (baseline), week 8 and 24, as well as by 
intervention group. Linear mixed models (LMM) will then be used to relate weekly assessments 
of body mass from week 0 to week 24 to the intervention, controlling for covariates likely to be 
associated with the outcome. Specifically, this will include baseline body mass and composition, 
and other demographic covariates including (but not be limited to) age, sex, race and 
socioeconomic status. Different slopes for time trend and intervention-time interaction term 
will be assumed for the intervention period (week 0-8) and follow-up period (week 8-24). 
Random intercepts will be used to account for correlations on the participant level. An 
advantage of this approach is treatment effect estimates remain consistent and approximately 
unbiased if missing data follow a missing-at-random pattern (MAR; data values are independent 
of missingness mechanism conditional on the observed data), the most general data-centric 
missing data assumption. Secondary analyses will fit separate LMM models to assess changes in 
fat mass and lean mass measured at week 0, 8 and 24. Similarly, LMM will be fitted for each of 
the eating behaviors and energy intake outcome collected for Aim 2 (detailed above), where 
skewed outcomes may be transformed to approximate normality. Bonferroni correction will be 
performed to adjust for multiple comparisons. 
Sample size, and power consideration: For a total of 100 participants randomized 1:1 to each 
study arm, we conservatively anticipate 20% attrition. This leaves us with complete data on 
n=80 participants total (n=40 per group). This provides ≥80% power for detecting differences in 
body mass (or other outcomes assessed in Aim 1 and 2) by at least 0.89 standard deviations. We 
expect power will be greater for our primary analysis models when adjusting for covariates 
associated with outcomes. Although we will have limited statistical power for the current 
analysis this trial will generate the effect size necessary to power a future trial, while allowing 
us to collect outcome measures on a practical amount of participants within the 2-year award 
period.