Partnering Lifestyle Intervention With Bariatric Surgery to Maximize Health Outcomes in Adolescents
Phase: NA
Conditions: Obesity, Adolescent, Bariatric Surgery Candidate
Sponsor: The University of Texas Health Science Center, Houston

IRB NUMBER: HSC-SPH-19-0406 
IRB APPROVAL DATE: 
03/04/2025 
 
Lifestyle Improvement for Teens with Bariatric Surgery 
NCT05393570 Unique Protocol Id HSC-SPH-19-0406 
 
 
 
MARCH 4, 2025 

IRB NUMBER: HSC-SPH-19-0406 
IRB APPROVAL DATE: 
03/04/2025 
Protocol Template Version Jan 2018 
Adapted from NIH protocol template and ICH Guidelines 
Protocol Title: 
Partnering Lifestyle Intervention with Bariatric Surgery to Maximize Health 
Outcomes in Adolescents. 
Principal Investigator: 
Sarah E. Messiah, Ph.D., MPH 
Co-Investigators:  
Study Coordinator:  
Population: 
Number of Sites: 
Study Duration:  
Subject Duration: 
Maryln Allicok, PhD, Folefac Atem, PhD, Sarah Barlow, MD, Bethany 
Cartwright, MD, Deanna Hoelscher, MD, and Jessica Klement, PhD.  
TBD 
Ethnically diverse adolescents ranging from 12 to 18 years of age who 
are severely obese bariatric patients at Children’s Health sites in the 
Dallas-Fort Worth area. 
Parents/guardians of children that are 18 years of age or older. 
All Children’s Health sites in the Dallas-Fort Worth area (COACH Clinic, 
Children’s Medical Center Dallas, Children’s Health Plano, and Children’s 
Specialty Center in Dallas). 
2 years 
18 months 
 
General Information 
Severe obesity, defined as ≥ 120% of the 95th percentile of body mass index (BMI) adjusted for age and 
sex or a BMI >35 kg/m2 is the fastest growing subcategory of obesity in the United States (US) pediatric 
population.1 Currently ~ 9% of 12-19 year olds have severe obesity, triple the prevalence in 1988-1994. 
Even more concerning, almost 12% of Non-Hispanic Black and 9% of Hispanic adolescents ages 12-19 have 
severe obesity compared to 7% of their non-Hispanic white ethnic group counterparts.2 Severe obesity in 
adolescence is associated with many cardiometabolic comorbidities, liver and kidney issues, lower sleep 
quality, as well mental health comorbidities including depression and anxiety, resulting in lower quality of 
life scores reported in this patient population.2-5 Moreover, severe obesity during adolescence tracks 
strongly into adulthood and is associated with adult asthma, arthritis, and poorer cardiometabolic and 
psychological risk profiles.6-9 As such, for the first time in decades, the life expectancy of Americans 
decreased in 2015-2016, a finding many attribute to obesity in addition to issues withopioids.10 
Background Information 
Metabolic and bariatric surgery (MBS) is shown to be safe and efficacious in treating adolescents 
(defined as ages 12-18 for this application) with severe obesity.11-13 Alternatively, weight-loss 
behavioral/lifestyle and pharmacotherapy treatment programs in inpatient and ambulatory settings for 

IRB NUMBER: HSC-SPH-19-0406 
IRB APPROVAL DATE: 
03/04/2025 
adolescents with severe obesity have not reported similar sustained weight loss trajectories, particularly 
in the long-term.14-19 Yet national adolescent MBS rates have not increased at the same rate of that of the 
severe obesity epidemic, and short-and long-term attrition (both to and from MBS) remains a significant 
challenge in this patient population. In fact, there is no standardized pre-and post-operative lifestyle 
intervention that is offered to adolescent MBS patients to support the behavioral changes that must occur 
to sustain successful weight loss. Given the extensive evidence-bases for (1) outpatient healthy lifestyle 
intervention to manage obesity21-30; and (2) MBS to treat obesity11-13, there is an opportunity to explore 
the combination or partnering of lifestyle intervention and MBS for adolescents with severe obesity to 
decrease attrition and improve health outcomes. Our team (Messiah et al, 2019)31,32 has called attention 
to the imperative need for research focused on the compound effect of MBS and lifestyle management, 
and how the timing or sequence of these weight loss approaches influence health outcomes. In other 
words, the field needs to more rigorously develop, evaluate (feasibility, acceptability) and test for when, 
and for how long lifestyle interventions (1) should be introduced in adolescents with severe obesity before 
MBS (for those medically cleared and who are planning on having MBS); and (2) should be included, and 
at what dosage (as well as specific content and timing) after MBS. Moreover, widening obesity-related 
health disparities warrant particular attention toward at-risk populations including ethnic minorities, and 
those with low socioeconomic status who are most impacted by the increase in, and comorbidities 
associated with severe obesity. Specifically, rigorous qualitative and quantitative research designs (e.g. 
mixed methods) should be applied to the research questions of (1) how lifestyle interventions can be 
combined/sequenced with MBS over time to optimize health outcomes; and (2) what critical behavioral 
strategies of lifestyle interventions from previous documented successes among adolescents with obesity 
can be enhanced, modified and/or adapted to increase the effectiveness (both in the short and long term) 
in the MBS patient population so they may enter adulthood with sustainable lifestyle skills to achieve 
healthier BMI developmental trajectories. As such, we propose the following mixed methods specific aims: 
Objectives 
 We will examine how lifestyle interventions combined with bariatric surgery over time can optimize 
treatment outcomes via the following aims: 
 AIM 1. Generate qualitative data necessary to adapt an existing evidence-based healthy lifestyle 
behavioral intervention’s content, strategies and delivery methods to explicitly support pre- and post- 
MBS, ethnically diverse (non-Hispanic white and black; Hispanic, other), adolescent patients and their 
families. This formative research will include focus groups, and key informant interviews with 
adolescents, parents, and clinical team members. 
 AIM 2. Adapt the healthy lifestyle behavioral intervention (referenced in AIM 1), as informed by AIM 
1 data (and analyses), to support pre-and post-MBS among ethnically diverse adolescent patients and 
their families. 
 AIM 3. Conduct a proof of concept study to assess feasibility, acceptability, and effectiveness of an 
MBS-supported healthy lifestyle behavioral intervention (adapted in AIM 2) among adolescent 
patients, their families, and their clinical team. Compare social determinants of health (SDOH) 
screening data with a comparable adolescent patient population from Children's Health. 

IRB NUMBER: HSC-SPH-19-0406 
IRB APPROVAL DATE: 
03/04/2025 
Hypothesis1: Acceptability and feasibility (adoption) of an adolescent-targeted multimedia lifestyle 
intervention sequenced with bariatric surgery with improve 3-and 6-month post-operative health- 
related outcomes. 
Study Design 
 This study will employ a mixed-methods design; AIM 1 will focus on qualitative data collection to 
inform adaptation of the intervention (AIM 2) and AIM 3 will conduct a pilot of the adapted 
intervention. 
 
A total of 75-85 metabolic and bariatric surgery (MBS) adolescent patients (< 18 years old), their 
parents and healthcare team will be recruited for the study. This will consist of 40-60 focus group 
participants (adolescent MBS candidates [n=24-36], their parents [n=16-24], and Key Informant 
Interviews [N=5]) and 20 for the proof-of-concept trial (AIM 3). Participants will be male and 
female, Hispanic, non-Hispanic black, non-Hispanic white, and mixed/other ethnicity and will be 
recruited from one MBS practice at Children’s Health System of Texas pediatric weight 
management clinic. We expect > 45% of the sample to be Hispanic, > 30% to be nonHispanic black 
and 5-10% multiethnic and 70% to be female. All study participants who enter the proof-of-
concept trial will be followed for 6 months after MBS. There will also be a variety of adult (parent 
and clinical team) participants who will engage in key informant interviews. These adults will be 
the parents of the adolescents (n~5-10) and clinical caregivers (n=5). We will collect and analyze 
the data from the focus groups and key informant interviews. Based on the information gathered, 
we will develop a proof of concept study that would support bariatric patients’ pre- surgery and 
post-surgery. We will then implement the proof of concept study (AIM 3) enrolling approximately 
20 ethnically diverse severally obese adolescent participants who have decided to have bariatric 
surgery/metabolic bariatric surgery (MBS). We will follow these participants for a period of 18 

IRB NUMBER: HSC-SPH-19-0406 
IRB APPROVAL DATE: 
03/04/2025 
months. This begins when the patients and their parent/caregiver provide consent to participate 
in the study. After bariatric surgery they will be followed for 6 months with 3-and 6- month 
measurement assessments. We will evaluate the effectiveness, accessibility, feasibility, and 
delivery of the program. We will look to identify what participants liked about 
the program 
and what they will recommend for improvements moving forward. We will also gather 
information about the contribution of the intervention in the patient’s weight loss outcomes 
post- surgery. During this process in Aim 3 we will provide a water bottle at their first clinic visit. 
Upon completion of the surgery participants may receive a FitBit,a scale, workout bands, and 
weights to aid in their weight loss journey. Incentives 
- 
For the focus groups and key informant interviews (AIM 1), participants will be provided with a 
$25 gift card. 
- 
For the pilot study (AIM 3),  participants  will  be  provided  with  a  total  of  $75  dollars  for their 
participation. These Participants will be followed over a period of 18 months. They will have a total 
of 3 follow-ups and with each follow-up they will be compensated with a $20, $25, and $30 gift card 
respectively. 
- 
For the Pilot study (AIM 3), participants may be provided with a FitBit, a smart scale, a home band 
set, a home weight set, and a water bottle. 
Study Population 
Inclusion criteria: (a) Must meet National Institutes of Health criteria to qualify for MBS for 
adolescents (BMI >35 kg/m2 and at least one existing co-morbidity [e.g. elevated blood pressure, 
hypercholesterolemia, etc.] or a BMI>40kg/m2). (b) Consents/assents to participate in the study. 
 Exclusion criteria: (a) Does not meet National Institutes of Health (BMI >35 kg/m2 and at least one 
existing co-morbidity [e.g. elevated blood pressure, hypercholesterolemia, etc.] or a BMI>40kg/m2); 
and/or (b) Refuses to participate in the study or (c) has diabetes that requires mealtime insulin. 
 Recruitment strategy for Pilot Study: All participants must be medically referred by a physician for 
bariatric surgery and have received psychological clearance for the surgery. Participants will be 
recruited from all Children’s Health sites in the DFW area, specifically from the Children’s Health 
Pediatric Gastroenterology Clinics and Children’s Health Pediatric Endocrinology Clinics. Clinic staff 
will recruit patients for the study, and schedule a convenient time to administer assent and parent 
permission form when needed. Clinical staff will use purposeful sampling when recruiting for the 
study. They will target ethnic minorities only, who are the primary target population for the study 
and grant. 
 Recruitment strategy for Focus Group and Key Informant Interviews: Severely obese adolescent 
participants who are 18 years old or younger and parents will be recruited by clinic staff at any of 
the Children’s Health Hospital in the DFW area to participate in the focus group. Clinic staff 
(surgeons, nurse and staff) will be recruited by the research team that have received IRB approval 
for this study. Research staff will reach out to the clinical staff, adolescent participants and parents 
via phone, email or in-person to discuss the nature of the study, and if interested schedule a time 
to administer consent. 

IRB NUMBER: HSC-SPH-19-0406 
IRB APPROVAL DATE: 
03/04/2025 
Study Procedures 
 There will be approximately 4 Children’s Health sites utilized for the study; COACH Clinic, 
Children’s Medical Center Dallas, Children’s Health Plano, and Children’s Specialty Center in Dallas. 
All participants will be recruited at one of these 3 sites. There will be 3 follow-ups with participants 
in the pilot study. They will be followed over the course of 18 months. This begin 12 months 
before surgery. During this time the participant will have a preoperative survey and will be given 
the intervention. After this period they will have two post-operative surveys at 3 months and 6 
months respectively. For the focus group and key informant participants they will be required to 
participate in only one focus group or interview lasting no more than an hour to an hour and a 
half. If focus groups participants are unable to attend focus group due to scheduling conflicts, time 
constraints or transportation issues they will have the option of participating in an in-depth phone 
interview, online-video interview or completing a survey. These interviews or survey will also take 
up to an hour to an hour and a half to complete. 
 The PI will also gather medical records of each participants such as pre-surgery BMI and post- 
surgery BMI and obesity related co-morbidity information to determine the effectiveness of the 
intervention program in supporting the health outcomes post-surgery. SDOH data will also be 
pulled from the medical records and will be compared to a similar patient population.  
EMR data will be gathered up to 18 months post-surgery. 
Study Measures 
 
AIM 3. Pilot test of the MBS-supported intervention. Based on work completed in study AIMS 1 and 
2 we will conduct a 9-month pilot test of the MBS-supported intervention in AIM 3 among 20 
adolescent patients meeting MBS/NIH qualifying criteria10 (class II obesity/120% of the 95th%ile and a 
co-morbidity, or class III obesity/140% of the 95th%ile according to CDC’s age-and sex matched growth 
charts). Subjects will be enrolled up to 3 months (and not < 1 month) pre-MBS and for 6 months post- 
MBS. We will provide a water bottle at their first clinic visit. Upon completion of the surgery 
participants may receive a FitBit, a smart scale, workout bands, and weights to aid in their weight loss 
journey. Recruitment. Recruitment will take place in the outpatient suites of either the COACH or MBS 
Clinics which are located in the Children’s Ambulatory Pavilion adjacent to the Children’s Health (CH) 
System of TX main hospital. The COACH clinic currently has a waitlist of over 200 patients for obesity 
treatment programs and > 50% qualify for MBS. A total of 234 patients < 18 years old have been 
referred to MBS from 2016 to 2019.92 
 
Intervention Delivery. After patient/parent consent is completed, participants will begin the pre-MBS 
intervention phase. A minimum of 6 online sessions will occur pre-MBS, and 20 will occur post-MBS. 
Dr. Klement, MBS coordinator and a diabetes educator in Co-I Cartwright/Qureshi’s clinic will manage 
session delivery to adolescents/parents. All content will follow the DPP-adapted curriculum flow. After 
The RA will perform outreach, reminder calls, and follow-up for missed surveys or online content. Pre- 
and post-MBS intervention delivery (based on adapted curriculum/model) may consist of a 
combination of 1-on-1 and group sessions (in-person or virtually), and online support tools, dependent 
upon adolescent/parent qualitative feedback on delivery method preference. 

IRB NUMBER: HSC-SPH-19-0406 
IRB APPROVAL DATE: 
03/04/2025 
 
Measures. We are including (1) demographic (age, sex, race/ethnicity, living situation, etc.), (2) 
anthropometric and cardiometabolic (lipids, insulin, glucose, blood pressure, HbA1c) (Table 2); (3) 
health-related quality of life (HRQOL)93; and (4) process measures (feasibility, acceptability of 
intervention content/delivery, guided by the RE-AIM [Reach, Efficacy, Adoption, Implementation, 
Maintenance] framework94--96) in the proposed study. We will also include standard-of-care pre-post  
MBS physical activity (past 7-day step counts, 24-hour diet recall assessments and the Family 
Assessment Device-12 item (parent and adolescent report of affective responsiveness and 
involvement, and problem solving within one's family); Clinical Measures. Anthropometric and 
cardiometabolic data will be collected at baseline and at 3- and 6-months post MBS as part of standard 
of care. All blood samples are documented in the Electronic Health Record. HRQOL. At 1 month pre- 
and 6-months post-MBS, we will administer the CDC’s HRQOL–14 Healthy Days Measure. This survey 
includes 3 modules (Healthy Days Core Module = 4 questions, Activity Limitations Module = 5 
questions, and the Healthy Days Symptoms Module = 5 questions). This instrument has been validated 
in the study age group.97 SDOH. Literacy, social, food, driving, financial, and housing needs, and tobacc use. 
 
Process Measures. Qualitative/quantitative process measures will be collected across all intervention 
sessions via embedded short surveys and at 6-months post-MBS to assess: acceptability (content was 
appropriate, interesting, easy to use), feasibility (recruitment, retention & adherence rates), and 
sustainability (perceived barriers/facilitator to intervention implementation, strategies) of the lifestyle 
intervention. All process measures will be guided by the RE-AIM framework which is particularly 
appropriate for assessing the fit and relevance of interventions in real-world settings.94-96  
The PI has integrated RE-AIM in her past obesity work.31,98 
 
Data Analysis Plan. The AIM 3 dependent measure for each dependent effect will be based on the 
change from pre to post-MBS weight loss/cardiometabolic resolution measurements (Table 2).  
Proportions and means will be the primary scales of the dependent outcomes used to evaluate Table 
Table 2. Anthropometric and Cardiometabolic Outcome 
Measures 
 
Anthropometrics 
 
Instrument 
(1) Raw Weight Loss 
Digital scale (to nearest 0.1 pounds) 
with the participants wearing light 
clothing, no shoes. 
(2) Body Mass Index  
(BMI) 
Digital scale and height (to nearest 
0.5 cm, via Accustat Genentech 
stadiometer) 
(3) Excess Weight Loss  
(EWL) 
Pre-MBS weight - follow up 
weight)/(Pre-MBS weight - ideal 
body weight) × 100% 

IRB NUMBER: HSC-SPH-19-0406 
IRB APPROVAL DATE: 
03/04/2025 
2 outcomes. We will use the 
Generalized  
Linear 
 
Model (GZLM) to model the 
impact of the intervention 
developed in AIM 2 for 
dependent effects.  
Much like the General Linear 
Model that allows for variation in type and scale characteristics of the independent effects, the GZLM 
extends this versatility to include various types of dependent variables.99 In GZLM, the relationship 
between the independent variables and the dependent outcomes is specified by way of a link function 
that defines the functional form of this relationship (e.g., when the dependent variable is a proportion, 
a logistic link function might be used). Through different specifications of the link and probability 
functions, one generalized model is used to examine the statistical relationships between the design 
parameters (i.e., independent variables) and the dependent variables, regardless of their scale 
properties. Statistical consideration is given to repeated measures (pre-, 3-, 6-month post-MBS data). 
Since the time component has only 2 levels (e.g., 1 pre, 2 post-MBS), there are minimal statistical 
complications associated with the autocorrelation structure of repeated measures. Measures taken 
at baseline will be included in the GZLM as covariates to ensure pretest balance and as a control on 
regression to the mean. Changes in weight will be analyzed by employing a generalization of the t-
test, known as Hetelling’s T2 test. This approach is very important in this case, since it same approach 
employed in the design. We shall assume a more conservative type I error of 1% to adjust for 
multiplicity.100 Missing Values: GZLM models will efficiently use the longitudinal data and 
accommodate attrition that is ignorable (essentially, missing at random, MAR).101 To assess sensitivity 
to MAR we will use approaches for the multivariate normal setting and others if normality is not 
reasonable.101 This avoids the problem of eliminating subjects with incomplete repeated 
measurements. SAS and JMP (SAS Institute, Cary, NC) will be the primary statistical software packages. 
Quality Control. PI Messiah will coordinate the QA/QC protocol with clinical and research staff. 
Appropriate checks will be conducted prior to, during, and after the completion of data collection. 
 
Statistical Power for AIM 3. A single-factor, repeated measures design with a sample of 20 subjects, 
measured at baseline, 3-, and 6-months, achieves 80% power to detect a contrast using a multivariate 
T² test at a 0.01 significance level. We reduce the type I to a more conservative 1% to correct for 
multiplicity. The standard deviation across subjects at the same time point is assumed to be 1. The 
pattern of the covariance matrix is to have all correlations equal with a correlation of 0.25 between 
the first and second time point measurements.100-103 The value of the contrast applied to the 
hypothesized means is 1.97 However, since we are anticipating an attrition rate of ~10%, we will recruit 
22 adolescent MBS patients. 
Data and Safety Monitoring 
 Data and Safety Monitoring: All subjects will have an assigned unique study identification number 
used on all data forms and instruments. Data are computer-linked to the remainder of the dataset on 
(4) Body Composition 
InBody570 body composition 
analyzer- muscle, fat and total body 
water measures 
Comorbidity Resolution  
(1) Cardiometabolic  
Profile 
lipids, insulin, glucose, blood 
pressure 

IRB NUMBER: HSC-SPH-19-0406 
IRB APPROVAL DATE: 
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each individual, and linking information between personal identifiers and study numbers is kept in a 
locked file cabinet in the Principal Investigator’s Office. Certain program staff (e.g., principal 
investigator, clinical team of Barlow, Cartwright, and Qureshi, study coordinator) will have access to 
confidential information needed to perform their respective duties, but the rest of the research staff 
are not privy to confidential information. 
 Potential Adverse Events. None of the proposed procedures involve invasive methods of data 
collection. Most of the proposed methods are part of, or an extension of, the standard of care to 
assess pre-post MBS surgery mental and physical health and are minimal risk. These studies present 
minimal discomforts to the patient. Should any adverse events occur during this protocol, the medical 
facilities at University of Texas are prepared to care for the study participants. All participants will be 
debriefed regarding any serious health information that might be discerned in the protocol. 
 Description of Adverse and Serious Adverse Events: Adverse events and serious adverse events 
identified for study participants that will be reported during protocol are: Adverse Events 
1. Family Crises 
2. Possible Violation of Confidentiality 
3. Extreme Distress due to Assessment Procedures 
4. Extreme Embarrassment or Distress in 
Response to Disclosing Sensitive Personal Information  
Serious Adverse Events 
1. Suicidal Thoughts or Attempts 
2. Abuse 
3. Threat of Danger to Others 
4. Hospitalization (psychiatric, drug related) 
5. Death 
 Procedures to safeguard against adverse events: All data collection protocols include a form on which 
research staff members record any problems with the data collection, concerns about the study 
subject or unusual occurrences during the collection. These forms allow our research staff an 
opportunity to quickly review and respond to any possible concerns or adverse effects. All adverse 
events will be monitored and supervised by the Principal Investigator. 
 Informed Consent: All participants will be required to read and sign detailed consent/assent forms 
before participating in the study. Participants are advised of the voluntary nature of this program and 
of their right to withdraw from the study at any time and/or request that information about 
themselves and their family be removed from data analyses. Each participant receives a verbal and 
written description of the study. Experienced research staff members are available at all points of the 
study process to answer questions and to explain assessment procedures, uses to which the data will 
be put, and confidentiality of data. Because our population consists of Hispanic participants, all project 
documents, including the consent/assent forms, will be available in both Spanish and English, and will 
be administered according to the expressed preference of the participant. If a staff member 

IRB NUMBER: HSC-SPH-19-0406 
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determines that a participant's reading skills are limited, all materials will be presented verbally in 
Spanish or in English, as indicated. Assessment questionnaires and anthropometric, cardiometabolic 
and biological measurements will be explained and conducted in the participant’s preferred language 
(Spanish or English). 
 Confidentiality Safeguards: To ensure confidentiality, all information will be coded so that it cannot 
be associated with any individual. A master sheet, with individual names and their respective code 
numbers will be kept in a locked file that can be accessed only under supervision of the Principal 
Investigator. All data entered into the computerized database will be identifiable by subject code 
number only. No one other than the Principal Investigator and the study coordinating team (TBA 
coordinator) will have access to records identifying subjects' names at any time. However, the 
facilitators will not have access to the data collected as part of the assessment. The information 
gathered will be used only for scientific, educational, or instructional purposes. 
 Mandatory Reporting Safeguards: Procedures to prevent the violation of confidentiality in accordance 
with reporting requirements are limited by the mandatory nature of these requirements. Subjects are 
informed in the consent document that staff must report to authorities 1) physical injury caused by 
other than accidental means, as required by ORS 419B.005 through 419B.040; and 2) information from 
a study participant which leads staff to believe a person is in imminent danger of physical harm. 
 Staff Training Safeguards: Every personnel on the study will be required to complete the CITI-Core 
course, an extensive, training/testing program which focuses on good clinical practice, to be certified 
by the IRB at the University of Texas. Study personnel will also have to be re-certified on a biannual 
basis by completing the CITI-CE course. 
 Research staff receive training specific to each assessment/measurement tool until they meet criteria 
for each assessment administration procedure. All project staff will meet on a weekly basis for ongoing 
training, monitoring of protocol, and problem solving. Questions regarding data collection will be 
promptly referred to the PI. 
 Research staff as well as facilitators will be trained to identify events that would fall under mandatory 
reporting guidelines. These include physical injury to any study subject caused by other than 
accidental circumstances or information from a study participant that leads staff to believe a person 
is in imminent danger of physical harm. 
 Data Safeguards: Identifying information is kept separately from the electronic or hard copy data sets 
at all times. During the analysis of the data, only the subject identification number is kept with the 
data. No information about the identities of study participants will be published or presented at 
conferences. 
 Discomfort or Embarrassment Due to Assessment Procedures Safeguards: During the course of 
participation in the research, a participant may have questions about the assessment and 
measurement procedures. A project staff member will be available to answer questions. Should a 
participant feel embarrassed or uncomfortable asking questions to a project staff member, the PIs will 
be available to answer questions or to handle problems encountered as a result of this project. 
 To prevent discomfort or embarrassment, all staff are trained in rapport building, skillful interviewing, 
and obtaining accurate measurements while minimizing the potential for stigmatization. Participants 

IRB NUMBER: HSC-SPH-19-0406 
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are informed prior to the assessment that they may choose to skip any question or procedure they 
find uncomfortable. If any individual becomes overly distressed or distraught during the assessment 
and/or clinical measures, the assessment will be stopped immediately and a staff clinician will talk 
privately with the affected individual(s). Appropriate referrals will be made as needed. 
 Discomfort with Disclosure Safeguards: During initial training, staff members will be coached by Dr. 
Messiah, to respond to embarrassment, discomfort, or distress in an appropriate and  
compassionate manner. If a participant experiences any other adverse reaction to the assessment, 
Drs. Barlow and Cartwright will be available to assess and refer the participant to appropriate 
services. Participants will receive specific written (in the form of a project description and PIs’ 
contact business card) and verbal instructions during the project consent procedures about how to 
contact a PI or project staff if necessary. 
 Dissatisfaction Safeguards: Participants will be encouraged to discuss with the project PIs or 
facilitators any possible dissatisfaction with the assessment/measurement activities. Referrals to 
alternative community services will be made at the study subject’s request or when it appears to be 
appropriate. 
Response procedures for adverse events 
Mandatory Reporting 
Staff must report two kinds of events that are potentially harmful to participants or others: adverse events 
and serious adverse events. 
Adverse Events 
Adverse events are those events that create distress for participants, such as (1) family crises; (2) possible 
violations of confidentiality; (3) extreme distress caused by assessment procedures; and extreme 
embarrassment or distress in response to disclosing sensitive personal information. Adverse events that 
are not serious will be logged into the project’s adverse events folder and noted in the participant’s study 
file. Serious adverse events will be logged and notated, and they will be reported to the PI immediately. A 
Serious Adverse Event form will be completed and sent to the Institutional Review Board of the University 
of Texas as well as the NIH project officer within 2 business days. 
1. Family crises 
Family crises involve a range of situations that threaten the ability of parents to provide essential support 
for their children and also include domestic violence or marital crisis, symptoms of mental illness in 
parents (e.g., depression and mania), and family environmental changes (e.g. homelessness). 
Assessment staff: Project staff will be trained by Co-I Klement and PI Messiah to recognize signs of family 
crises and to consult with the PI. Together they will determine the best response to the patient's needs, 
including referral, if so indicated. Project staff will be trained to recognize symptoms of severe problem 

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behavior, extreme family disagreements, domestic violence, marital crisis, and mental illness. Participants 
in the project will have emergency numbers to call if there is a crisis situation involving the parent's use 
of the curriculum tools that may have resulted in a problem situation that escalates, such as violence to 
others in the household. 
2. Possible Violations of Confidentiality 
When any staff member becomes aware that participant confidentiality has been violated, the staff 
member is required to report this to the PI. The PI will then meet with the staff member who violated 
confidentiality, will review the information and determine next steps. If the suspected staff member is 
found to have violated participant confidentiality, the staff member will be terminated. The incident will 
be reported to the University of Texas IRB and to the NIH project officer within 5 business days. 
3. Extreme Distress Caused by Assessment Procedures 
In cases where a participant reports or displays extreme distress in response to assessment/measurement 
procedures/battery, the assessment will be discontinued immediately. Staff will be trained to identify and 
handle signs of participant distress and will contact the project facilitator(s) and /or PI who will assess the 
participant’s distress level and will refer her/him to counseling if necessary. In cases of extreme distress 
caused by assessment procedures, a notation will be made in the participant’s study file. 
4. Extreme Embarrassment or Distress in Response to Disclosing Sensitive Personal Information 
If a participant reports or displays extreme embarrassment or distress in response to requests for sensitive 
personal information (e.g. eating behavior, other psychopathology), the assessor will discontinue the 
assessment and will refer the participant to counseling if necessary. In cases of extreme embarrassment 
or distress caused by disclosing sensitive personal information, a notation will be made in the participant’s 
study file and the study coordinator will be notified. 
Serious Adverse Events 
Serious adverse events refer to events that place participants or others in imminent danger. Such events 
include suicidal ideations or intentions, instances of physical abuse, neglect or threat of physical harm 
among participants to themselves or others. Other serious adverse events, in which harm to participants 
or others has already occurred, must also be reported. Such events include hospitalization or death. To 
anticipate these concerns, the project has established procedures and guidelines to respond to risk 
disclosures and crisis situations among subject families. Assessment staff will be trained to recognize risks 
or crises that require immediate reporting response. Five types of situations require special procedures: 

IRB NUMBER: HSC-SPH-19-0406 
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03/04/2025 
1. Suicidal Thoughts or Attempts 
Two types of risks will be addressed in the project: (a) ideation or the presentation of thoughts or interest 
in suicide, and (b) action, which includes both thoughts of suicide as well as the presence of a plan and 
means to accomplish a suicide act. 
The participants will complete all self-report measures in conjunction with direct entry onto a laptop. 
The research coordinator will be required to review identified instruments and items for response values 
that indicate suicidal ideation or plans for action. Based on the response, the coordinator will be required 
to review disclosure information with the PI and, if deemed necessary, conduct follow-up inquiry with the 
participant to further determine level of risk. If the participant is determined to present immediate risk of 
suicidal action, one of the staff facilitators, will develop a safety plan with the client and make indicated 
referrals. In the most extreme cases of risk, the staff facilitator assumes follow-up responsibility for the 
plan of action with the family. 
2. Abuse 
Child/adolescent or spousal/partner abuse concerns may arise from any or a combination of the 
following sources: (a) the participant verbally indicates that abuse has occurred or is occurring, or (b) 
the participant is observed with bodily injury (e.g. bruises, burns, black-eyes) whose origin appears to 
differ from the explanation given of the injury. Abuse is considered a serious adverse event because it 
represents an imminent danger to the person.  
At any time during the assessments, if any of the above information leads staff to suspect abuse or 
neglect, steps are outlined for staff to obtain additional information, document the information in the 
participant’s study file and contact the study coordinator. Based on the information, the coordinator will 
advise the PIs and follow-up regarding communication to the family, appropriate further inquiry, follow- 
up, and reporting. The PI will be notified to review the information and determine next steps. If abuse 
is 
indicated, the project coordinator will report abuse to protective services on behalf of the participant. 
3. Threat of Danger to Others 
The threat of danger to others includes disclosure of potential physical harm by a participant to others, 
including members of the participant's family or other individuals in the community. 
At any time during the assessment, if any information derived lead staff to suspect a participant poses 
a threat of harm to others, steps are outlined for staff to obtain additional information, document the 
information and contact the PI. 
4. Hospitalization 
Participants’ hospitalization (both for physical and psychiatric conditions) will be documented and 
reported (see reporting procedures for serious adverse events below). 

IRB NUMBER: HSC-SPH-19-0406 
IRB APPROVAL DATE: 
03/04/2025 
5. Death 
If a project staff member is advised of the death of a participant, the project staff member will document 
the death in the participant’s study file and report the death to the PI. 
Reporting procedures for adverse events 
An Adverse Events and Serious Adverse Events form will be used to record any events. 
The anticipated potential adversity inherent in assessment is limited to those situations described above 
and is addressed by the timely intervention of a licensed project facilitator skilled in risk assessment and 
mandatory reporting requirements. 
The prevalence of adverse events described above will be reported both to our IRB and to NIH through 
annual progress reports. We will also report adverse events to others, as directed by our IRB or NIH 
Program Official. 
Reporting 
Procedure 
for 
Serious 
Unanticipated 
Adverse 
Events  
In the event of an unanticipated serious adverse event, the project PI will ensure that these events are 
reported to the NIH Program Official and the University of Texas IRB within 24 hours by phone, fax, and/or 
email and will submit a written report to the Program Official within two days. The project staff will utilize 
the following reporting procedures: 
1. When the project staff and/or PI become aware of a serious adverse event, reporting 
requirements must be implemented in a timely manner. 
2. PI completes a Serious Adverse Event Reporting Form and submit the form to the University of 
Texas IRB within two days. Serious adverse events include any hospitalizations or other life- 
threatening conditions (see serious adverse events above). All serious adverse events will be 
examined for the need for appropriate referral, an assessment of relatedness to the project, the 
need for any additional documentation and/or follow-up, and modification of the Informed 
Consent and notification of existing participants. All adverse events that are ongoing will be 
followed until they stabilize or resolve. Dr. Messiah will resolve each adverse events or serious 
adverse event and will consult with the IRB, as necessary. 
3. The PI will review the study protocol and determine what further action to take based on the best 
interests of the participants and of the research and submit to the IRB for approval. 
Oversight: Dr. Messiah, the Principal Investigator, will administer the Data Safety Monitoring Plan for 
this project and report all results of the yearly reviews to University of Texas IRB and the NIH Project 
Officer. Events specifically examined will include (but are not limited to) psychiatric hospitalization, 
suicidal attempts, and abuse. No planned interim statistical analyses will be performed, though the 
occurrence of events by condition will be examined in tabular form. Should trends become apparent 

IRB NUMBER: HSC-SPH-19-0406 
IRB APPROVAL DATE: 
03/04/2025 
that indicate the potential for significant imbalance by condition, a special board will be convened to 
review the data and make a recommendation as to the disposition of the trial. Any action that results in 
the temporary or permanent suspension of the project will be undertaken with consultation with the 
study’s NIH project officer and the University of Texas IRB. 
The University of Texas is responsible for the general oversight for all grants. Each study is reviewed yearly 
by the IRB during the regular continuing review process, outlining the following points: 
 Reassessment of the risks and benefits to study participants 
 Participant recruitment, accrual, and retention 
 Confidentiality 
 Consideration of external scientific or therapeutic developments with impact on the safety of 
participants 
 Review of adverse events The PI will update the general DSMP procedures as needed. 
Statistics 
 This study was designed around the maximum sample size possible given the logistical limitations of 
the study (time, expense). For a total sample size of 25 subjects (Aim 3, the power associated with 
any of the independent effects in any of the proposed statistical models will be approximately 80% 
(P value cutoff = .01) as long as the effect accounts for 3% of the total variance relative to the model 
specific error term (i.e., R2 = .03). This will be true for any effect that is included in any of the statistical 
models either pre or postoperative and includes both main effects and possible interactions. The 
power will change slightly due to the complexity of the model and the number of independent effects 
included, but overall, considering the tradeoff between increased efficiency and lose of error degrees 
of freedom in more complex models, the power will remain at approximately  
80% when 3% of the variance is explained. This axiom also holds no matter the scale of 
measurement (i.e., continuous or discrete). An R2 of .03 equates to a “d” statistic (i.e. Cohen’s d) of 
approximately .35. According to Cohen’s taxonomy for the social sciences, this is a small to medium 
effect size. Effects accounting for less than 3% of the total variance are most likely of limited clinical 
significance. As previously stated in the statistical methods, considering the observational nature of 
the investigation, we have chosen to use a more conservative P value cutoff. More importantly this 
conservative standard also increases the chances of reproducibility and helps to account for the 
amount of statistical modeling/testing that increases the likelihood of irreproducible results. 
Ethics 
 For all study participants the initial consent process will take place during recruitment process by 
clinical staff and research staff. However, if a willing participant does not have time to learn about, 
and sign all consent forms, study staff will schedule a follow up time with them to consent. If 
needed participants will be allowed to take consent home to review before speaking to research staff 
or clinical staff administer consent. 

IRB NUMBER: HSC-SPH-19-0406 
IRB APPROVAL DATE: 
03/04/2025 
Data handling and record keeping 
 Quality control and assurance. Data storage and management will be accomplished via 
FileMaker Pro, a cross-platform object-oriented relational database application. Our 
database manager will be responsible for the development, security, backups, audit 
logs, and managing database user access. Regarding data/records confidentiality, we 
have an established set of procedures designed to ensure the protection of 
confidentiality. All records on active participants will be stored in locked file cabinets in 
the office of the Principal Investigator, who will maintain strict control over these 
records. As in our other studies, we will use a record system in which all participant 
records are filed numerically by case number, with no names attached to the 
database. Access to the database and data files is strictly controlled by the Principal 
Investigator. Passwords are used to restrict entry into the database. Project staff is 
specifically trained on issues of confidentiality. Facilitators will also be trained on 
issues of confidentiality. 
 Filemaker Data Management Platform. The database manager will develop a web- 
based relational database using FileMaker Pro, a secure cross-platform object-oriented 
relational database application for electronic collection and management of research 
and clinical study data. The database design will replicate the proposed data collection 
forms and will be developed in accordance with necessary security, compliance, and 
study requirements, with oversight from the study’s PI. The data collection team will 
be able to enter data into the database through a secure website. Access to and user 
privileges within the database will be managed using the UT single sign-on(SSO). 
Quality control and assurance 
 Quality Assurance: Accuracy and Completeness of the Data during Data Collection, Entry,  
Transmission and Analysis. The project lead coordinator will be entrusted with scanning spot check 
10% of the data after entry to ensure accuracy and check questionnaires for completeness as they 
care collected. Field team staff will follow-up with study participants and concerning questions that 
are skipped. Participants are allowed to decline to answer, but data checking is in place to ensure 
that data is not missing due to unintended circumstances. 
 Data Integrity: To maintain data integrity, fields within the FileMaker application will have data type 
validation, simple ranges, and/or constraints. Data type validation will check that the entered data 
fits into the field type (e.g. a date field only accepts data entered in a date format). Simple ranges 
ensure that the data entered fits within the minimum and maximum values. Constraints check for 
invalid characters or values. Additionally more advanced checks can be done, such as cross- 
reference and structured validations. Additionally, ad-hoc reports can be generated to check for 
data accuracy during the data collection process. Access to this feature will be restricted to required 
users using user privileges. 

IRB NUMBER: HSC-SPH-19-0406 
IRB APPROVAL DATE: 
03/04/2025 
 Data Export for Analysis: Data can be exported out from FileMaker in various ways and in various 
formats. Data may be exported as a CSV (comma-delimited) file from a report or as a PDF file from 
the data entry page when viewing a particular record. Additionally, all collected data can be exported 
to CSV, XML, DBF, or Microsoft Excel file types. Other database management systems and/or 
statistical software, such as SAS or SPSS can interface via open database connectivity (ODBC). This 
interface allows for direct data importing, running SQL queries, generating ad-hoc reports, and 
accessing the data in real time. Access to these features will be restricted to authorized users using 
user privileges. 
 Data confidentiality, Storage and Preservation: At the completion of the data collection process, 
access to the database by the data collection team will be disabled. Study coordinators and the PI 
will continue to have access for any required data cleaning. At the completion of the proposed study, 
access to database will be removed for all nonessential team members and further data modification 
will be disabled. All data will then be transferred from the database server into a 256- bit AES 
encrypted archive file and will only be accessible to the PI and a secondary co-custodian. All 
participants will be assigned a unique code number by PI Messiah. This ID number will be used on 
all response forms, spreadsheets and data files to ensure participant confidentiality. Participant 
name, address, telephone, and any other means of identification will be destroyed following the 
completion of data collection using methods described by the IRB. All study personnel are equipped 
with password protected personal computer access and password protected access to a network 
drive accessible only from project staff computers. All computers and network drives are maintained 
by UT Health’s Information Technology Department (IT). 
 Data Security. For added security and reliability, the FileMaker environment is separated into two 
servers, a web server and a database server. Data entry is done through the web server only and 
users do not have direct access to the database server. All transmitted data is encrypted using HTTPS 
and Secure Socket Layer (SSL) encryption, to maintain secure communication from the user to the 
web server. All incoming data is then sanitized and stored using AES-256 encryption on the database 
server. Both servers will be managed by UT Health’s Information Technology and are physically 
located at its data center and covered by its security policies. Which include continuous network 
scans, penetration testing, daily patches, off-site tape backups, and other enterprise-level data 
management procedures. Additional security is implemented at the application level. FileMaker 
maintains a built-in audit trail that logs all events, user access, and data  creation and 
modifications. Log files can be exported for analysis and reporting purposes. All collected data is 
backed up hourly with redundant nightly backups stored to a separate server going back 6 months.  
Database consistency checks for errors and server maintenance also occur daily. 
 Finally, a Data Safety Board will monitor all adverse events. Possible adverse events include those 
cases identified above as well as emotional distress associated with assessment or study 
participation. Adverse events will be reported to the chair of the committee as soon as possible and 
no later than 24 hours after they occur. Appropriate measures will be taken to ensure the 
participant’s safety including referrals to primary care physician or supportive counseling provided 
by intervention staff. A summary of all adverse events will be sent to the chair of the Data Safety 

IRB NUMBER: HSC-SPH-19-0406 
IRB APPROVAL DATE: 
03/04/2025 
Board every month. At least monthly, the Data Safety Board will review all adverse incidents via a 
face-to-face meeting. This committee will have the power to suspend recruitment to the study or 
discontinue the study entirely if they have concerns about the safety of the participants or the study 
itself. 
Publication Plan 
 Results from this study will be published in leading peer-reviewed journals. The PI 
anticipates a minimum of 6 final published manuscripts. These aggregate results 
will be available to research subjects and they will be made aware of their 
existence. 
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03/04/2025 
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03/04/2025 
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Patients. Obes Surg. 2020 Feb 15. doi: 10.1007/s11695-020-04454-y. [Epub ahead of print] 
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Dis. 2020 Feb 10. pii: S1550-7289(20)30073-3. doi: 10.1016/j.soard.2020.01.031. [Epub ahead of 
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pandemic in people with obesity. Clin Obes. 2021 Feb 4:e12440. doi: 10.1111/cob.12440. Epub 
ahead of print. PMID: 33539652. 
50. Almandoz JP, Xie L, Schellinger JN, Mathew MS, Gazda C, Ofori A, Kukreja S, Messiah SE. Impact of  
COVID-19 stay-at-home orders on weight-related behaviours among patients with obesity. Clin  
Obes. 2020 Oct;10(5):e12386. doi: 10.1111/cob.12386. Epub 2020 Jul 12. PMID: 32515555; PMCID: 
PMC7300461.46,47 

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51. Morales-Marroquin E, Kohl HW 3rd, Knell G, de la Cruz-Muñoz N, Messiah SE. Resistance Training in 
Post-Metabolic and Bariatric Surgery Patients: a Systematic Review. Obes Surg. 2020 
Oct;30(10):4071-4080. 
52. Morales-Marroquin E, Xie L, Meneghini L, de la Cruz-Muñoz N, Almandoz JP, Mathew SM, Schneider 
BE, Messiah SE. Type 2 Diabetes and HbA1c Predict All-Cause Post-Metabolic and Bariatric Surgery 
Hospital Readmission. Obesity (Silver Spring). 2021Jan;29(1):71-78. 
53. Messiah SE, Lopez-Mitnik G, Winegar D, Sharif B, Arheart K, Reichard K, Michalsky M, Lipshultz SE,  
Miller TL, Livingston A, de la Cruz-Muñoz N. Ethnic Group Differences in Weight Loss Among 
Adolescents Undergoing Bariatric Surgery: 1-Year Results from the Bariatric Outcomes 
Longitudinal Database (BOLD). World Journal of Diabetes, 2013; 4(5): 88-91. 
54. Spadola CE, Wagner EF, Varga LM, Syvertsen JL, De La Cruz Munoz NF, Messiah SE. A Qualitative 
Examination of Increased Alcohol Use after Bariatric Surgery among Racially/Ethnically Diverse 
Young Adults. Obes Surg. 2018; 28(6):1492-1497. 
55. Spadola CE, Wagner EF, Varga LM, Syvertsen JL, De La Cruz Munoz NF, Messiah SE. Response to 
Letter to the Editor: Alcohol Use Disorders and Bariatric Surgery. Obes Surg. 2018; 28(10):3306- 
3307. 
56. Spadola CE, Wagner EF, Accornero VH, Vidot DC, de la Cruz-Munoz N, Messiah SE. Alcohol use 
patterns and alcohol use disorders among young adult, ethnically diverse bariatric surgery patients. 
Subst Abus. 2017; 38(1):82-87. 
57. Spadola CE, Wagner EF, Dillon FR, Trepka MJ, De La Cruz-Munoz N, Messiah SE. Alcohol and Drug 
Use Among Postoperative Bariatric Patients: A Systematic Review of the Emerging Research and Its 
Implications. Alcohol Clin Exp Res. 2015 Sep; 39(9):1582-601. 
58. Vidot D, Prado G, Spadola C, de la Cruz- Munoz N, Cuesta M, Messiah SE. Post-Operative Marijuana 
Use, Food Addiction, and Disordered Eating among Bariatric Surgery Patients. Surge Obes Rel Dis 
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Attachments 
1. NIH Grant submission application