A Novel Family E-Health Intervention Process To Reduce Childhood Obesity
Phase: NA
Conditions: Obesity, Life Style, Healthy, Behavioral Changes
Sponsor: University of North Texas Health Science Center

                                                         North Texas Regional Institutional 
Review Board (IRB)
 
Protocol Synopsis for Research Project Involving Human Subjects 
PROTOCOL INFORMATION 
Title of Research Activity:  Lifestyle Medicine Health Education and Intervention Program “Family Central E-
Health”.
Name of Principal Investigator: Christina Robinson, MD
Institution: University of North Texas Health Science Center
Names of each Co-Investigator:  Maya Nair, PhD (University of North Texas Health Science Center)
Sponsoring Agency / Company (if applicable):  Ardmore Institute of Health, NIH 
Sponsor’s Protocol Number (if applicable):  PA-19-053
A. Specific Aims – State the specific scientific objectives of the research. 
1) To examine and quantify the improvement in the knowledge, attitudes, and lifestyle behaviors of
caregivers (e.g. parents, grandparents, aunts, uncles) of Pediatric Mobile Clinic patients toward the
six “Family Central” topics (including Nutrition, Physical Activity, Tobacco Avoidance, Sleep,
Stress Management, and Social Connection). The randomized control study will consist of two 
research arms either a) text message reminders of health education available to participants through 
the patient portal of the electronic medical record of their child or b) text message briefs about six 
Family Central topics. 
2) To examine and quantify the improvement in five vital signs [including blood pressure, blood 
glucose, total cholesterol, waist circumference, and body mass index (BMI) of caregivers (e.g. parents,
grandparents, aunts, uncles) of Pediatric Mobile Clinic patients at the onset and throughout the
“Family Central” program that includes the total period of 6 months.
B. Background and Significance -Briefly sketch the background leading to the present proposal.  Describe 
the contributions  that the study  may make  to the health  of human beings  and/or to the scientific 
community, using documentation from the literature, where appropriate.  Although it is helpful for the 
Board to have a decent understanding of the basis for conducting a research project, it is not necessary 
to have a full-blown literature review or extensive background and rationale for the proposed research 
plan of activity. 
Worldwide, two-thirds of deaths are attributed to chronic disease such as cardiovascular disease, 
diabetes, and cancer (WHO, 2012). The situation is the same in the United States, with Americans 
being even less healthy in terms of chronic disease, when compared to countries of similar income. In 
fact, chronic conditions related to lifestyle are increasing (Johnston & Moreno, 2014). According to the 
Centers for Disease Control and Prevention, half of all adults in the United States have one or more 
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chronic disease, with one quarter of adults having two or more (CDC, 2012). Heart disease and cancer 
are two lifestyle related chronic diseases that contribute to 46% of all deaths in the United States 
(CDC, 2012). Additionally, evidence indicates that the root causes of chronic diseases are associated 
with adverse lifestyle factors that include smoking, physical inactivity, poor diet, stress, negative 
emotion, etc. (CDC, 2012). New research indicates that children of mothers who have a healthy 
lifestyle have a much lower risk for obesity compared to children whose mothers do not have healthy 
lifestyles (Dhana et al, 2018). Conversely, Parental obesity more than doubles the risk of adult
obesity among both obese and non-obese children under the age of 10 years old. (Whitaker et al. 
1997).
The pattern of chronic disease rates in Tarrant County are like those of the United States and the state 
of Texas in general. The leading causes of death are heart disease, cancer, and cerebrovascular 
disease—all of which are related to lifestyle behaviors (Brewer et al., 2012). Prevalence of chronic 
disease is increasing in Tarrant County, with rates of hypertension, heart disease, and diabetes rising 
between 2004 and 2009 (Brewer et al., 2012). All three of these diseases disproportionately affect 
African Americans, who experience much higher rates than any other racial/ethnic group in Tarrant 
County (Brewer et al., 2012). Tarrant county also has a higher percentage of smokers (18.5%) 
compared to the rest of Texas (15.8%), further contributing to chronic disease rates (Brewer et al., 
2012). Two-thirds of Tarrant County residents are overweight or obese while only one-fourth regularly 
meet fruit and vegetable consumption recommendations (Brewer et al., 2012). Additionally, less than 
half meet CDC recommendations for physical activity (Brewer et al., 2012). Although overweight and 
obesity rates are high among all residents, they are disproportionately higher among racial/ethnic 
minorities, specifically Hispanic/Latinos and African Americans (Brewer et al., 2012).
With lifestyle behaviors accounting for the leading causes of disease and mortality, it is a necessity to 
use lifestyle medicine interventions to shape behavioral choices in order to prevent and treat chronic 
disease while promoting overall health and wellness. Lifestyle Medicine can prevent up to 80 percent 
of chronic disease (American College of Lifestyle Medicine, 2015). Additionally, lifestyle changes have 
the potential to reverse existing chronic disease (ACLM, 2015). A recent Lifestyle Medicine study found 
that health education and promotion of behaviors such as increased fruit and vegetable intake, tobacco 
cessation, and participation in physical activity have been successful at reducing obesity and 
preventing related chronic conditions among Hispanic adults (Tucker et al., 2016). For most 
individuals, reaching a healthy Body Mass Index (BMI) requires not only behavior change, but also 
social and educational support (Johnston & Moreno, 2014). This can be accomplished through 
community health promotion efforts aimed at changing behaviors and supporting the target population. 
Lifestyle interventions have also successfully improved adherence to healthy behaviors and some 
biometric health markers (e.g. blood pressure) in varying populations, including African-Americans and 
Hispanic/Latinos (Dickinson et al., 2006; Kent et al., 2015; Pekmezi, Marquez, & Marcus-Blank, 2010; 
Tucker et al., 2014; Tucker et al., 2016). It is especially important to assist modifying health behaviors 
in populations of low socioeconomic status and ethnic and racial minority groups who are 
disproportionately affected by chronic disease such as overweight and obesity, hypertension, heart 
disease, and diabetes (Tucker et al., 2014; Brewer et al., 2012). Additionally, community health 
promotion programs help deinstitutionalize healthcare by having medical providers directly in the 
community and making health promotion more accessible to those who traditionally do not have good 
access to medical care (Tucker et al., 2014).
The University of North Texas Health Science Center (UNTHSC) Pediatric Mobile Clinic, run by 
pediatrician Dr. Christina Robinson, currently provides free medical care and vaccines to uninsured 
children in underserved areas of Fort Worth. The mobile clinic reaches patients who generally do not 
have good access to care by driving directly to each neighborhood, helping overcome transportation 
barriers and financial constraints that a traditional medical appointment can cause for low-income 
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individuals. The families in the neighborhoods served by the Pediatric Mobile Clinic are primarily 
African American or Hispanic/Latino. The health concerns among mobile clinic families reflect a need 
for a Lifestyle Medicine intervention to promote healthy eating, physical activity, and other healthy 
behaviors to prevent and treat disease and promote health among caregivers, thereby improving the 
health of the entire family.
In collaboration with the lifestyle medicine specialist, the mobile clinic team has planned to conduct a 
lifestyle medicine oriented mobile clinic health education and intervention program for participant 
groups which come from current Pediatric Mobile Clinic sites in the following neighborhoods: 
Morningside (a community in East Fort Worth), Northside (a community in North Fort Worth), and Stop 
Six (a community in Southeast Fort Worth bordered by Lancaster Street, East Loop 820, and South 
287). 
The purpose of the present study is to conduct a Lifestyle Medicine oriented E-health education and 
intervention program to improve lifestyle behaviors among caregivers leading to health promotion and 
disease prevention regarding the selected six core Lifestyle Medicine topical areas: Nutrition, Physical 
Activity, Tobacco Avoidance, Sleep, Stress Management, and Social Connection to caregivers of 
Pediatric Mobile Clinic patients in the Mobile Clinic setting. This research was originally funded by 
Ardmore Institute, which will be completed in April 2020. The NIH recently awarded funding to support 
the research as well which will be the main funding source for this study after April 2020. This research 
is covered by a Certificate of Confidentiality from the National Institutes of Health, which prevents 
researchers from releasing information, documents, or samples that may identify participants in any 
action or suit including federal, state, local, civil, criminal, administrative, legislative, or other 
proceedings. 
C. Preliminary Studies -  Summarize preliminary studies conducted by the investigator pertinent to this 
proposal. State "none" if applicable. 
For a sense of feasibility, the team conducted a trial of Lifestyle Medicine health education sessions 
on the six topics to the caregivers at four summer camps in the Stop Six area. Most participants 
wanted to know their vitals and how those numbers related to their health. Participants were all 
provided a health education booklet along with guided discussion of the topics. The program was 
well received by participants, and they voiced a desire for further information on the six Lifestyle 
Medicine topics.
D. Investigator Experience -Provide a brief synopsis of the principal investigator’s expertise, experience, 
and capability to perform this research.  Submit a copy of the curriculum vitae of the principal investigator 
in IRBNet.
Dr. Christina Robinson: Principal Investigator (Pediatrics)
Dr. Christina Robinson has taken a leadership role in providing health care directly to children in 
Fort Worth’s most underserved communities. As the medical director of the new UNTHSC Pediatric 
Mobile Clinic, she is helping provide high-quality health care at no cost to families. The overall goal 
of her work is to improve the health and wellbeing of underserved patient populations and their 
communities. As the first college graduate and physician in her immediate and extended family, her 
familiarity with the difficulties that arise from limited resources inspired me to find feasible solutions 
for underserved patients. Although her ultimate goal was to become a physician, she realized that 
health is impacted by our culture and community, so she pursed my bachelor's degree in Sociology 
to help her understand the theoretical basis of culture. Her current work on the UNTHSC Pediatric 
Mobile Clinic has reinforced for her the interplay of social determinants on health outcomes. This 
complexity continues to challenge her to advocate for communities that often are forgotten and 
under-represented in research and policies. Her hope is to discover the bridge between theoretical 
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solutions and clinical solutions that will transform patient behavior choices and translate to 
improved health outcomes.
E. Experimental Design and Methods - 
      
This randomized control study will examine knowledge, attitudes, and healthy lifestyle practices 
regarding six “Lifestyle Medicine Health Education” topics including Nutrition, Physical Activity, 
Tobacco Avoidance, Sleep, Stress Management, and Social Connection, among caregivers (e.g. 
parents, grandparents, aunts, uncles) of Pediatric Mobile Clinic patients. In addition, clinical outcomes 
such as blood pressure, blood glucose, total cholesterol, waist circumference, and Body Mass Index 
(BMI) within this population will be assessed; and the study will assess the change in outcomes from 
baseline to completion of this “Family Central” program. As a contingency plan in light of the disruption 
recently caused by COVID-19, we will also offer electronic informed consent and HIPPA authorization 
via DocuSign. Caregivers may request to complete consent procedures using a combination of phone 
and mail/fax if they have concerns about electronic completion. All potential participants will be offered 
the opportunity to ask questions via email, phone, or video conference with a member of the research 
team prior to or after enrollment. After enrollment, we will deliver a scale and a tape measure to the 
caregiver at the address of their choice. The measurements will be submitted via our text-messaging 
platform. The caregiver will complete a virtual training on correct measurement of height, weight, and 
waist circumference. Participants will be stratified to groups based upon enrolling family member’s BMI 
and child’s BMI measured at the time of randomization. Participants will be assigned into one of two 
research arms a) the e-health intervention group or b) a control group of usual care. All participants will 
engage in the study with non-web- based, two-way SMS text messaging via their personal cell phone. 
Data will not be used to participate. However, SMS text messages will be used. The e-health 
intervention group will receive health education briefs that will cover all six lifestyle modifications every 
6 weeks. Over the 6-month study period, each lifestyle modification topic will be covered 4 times. The 
usual care group will receive text messages directing caregivers to consult the electronic medical 
record patient portal of their child, which has a library of health literature, related to lifestyle behaviors, 
their child’s lab results, and appointment reminders. There is no information about the caregiver listed 
in the child’s medical record. When caregivers complete the intervention, they will be permitted to keep 
the tape measure and scale, and will be compensated for their study participation if they join a live or 
virtual community celebration within 30 days of receiving the celebration invitation. A description of this 
clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This website will 
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not include identifiable patient information but will include a summary of the results. The research is 
based on the following hypotheses:
Primary Hypothesis: The participants will improve knowledge, attitudes, and behaviors towards 
six healthy lifestyle topics (Nutrition, Physical Activity, Tobacco Avoidance, Sleep, Stress Management, 
and Social Connection) after participating in the e-health “Family Central” program offered by the 
Pediatric Mobile Clinic.
Secondary Hypothesis: The participants will improve their health status including five vital signs 
(blood pressure, blood glucose, total cholesterol, waist circumference, and Body Mass Index) after 
participating in the “Family Central” sessions offered by the Pediatric Mobile Clinic.
1) Methods and Procedures - Describe the procedure (s) in sequential detail. Describe the methods. Clearly 
identify any experimental elements of the study. Include a thorough description of any investigational 
drugs, therapeutic procedures, monitoring techniques, test procedures or medical devices. 
[The description of investigational medical devices should include information about each important 
component, ingredient, principle of operation, and anticipated developmental changes in the device. On a 
separate page, describe and address issues associated with the device presenting “Significant Risk” or 
“Non-Significant Risk”] 
i.
Recruitment 
Upon approval by UNTHSC IRB, participants who are the caregivers of patients will be recruited during 
Pediatric Mobile Clinic patient visits in the communities: Morningside, Northside, and Stop Six. 
Participants will be recruited by electronic and printed flyers posted on the website for UNTHSC 
Pediatric Mobile Clinic and forwarded to community partners of the Pediatric Mobile Clinic for public 
posting. The study team will recruit participants individually when caregivers accompany pediatric 
patients to the mobile clinic during regularly scheduled clinic days in these communities or contact the 
Pediatric Mobile Clinic research team. The caregivers will receive an explanation about the study while 
they are registering their child for a clinic visit or as a follow-up call to a participant initiated message. If 
the caregiver is interested, they will be able to complete a pre-screening form for themselves. Inclusion 
criteria are family member has a child who is a current or former patient of Pediatric Mobile Clinic with 
a medical diagnosis of overweight/obese, defined as BMI percentile of 85% or above, age of the child 
is 6 months to 11 years old, family member is a primary caregiver to the child, family member over the 
age of 18 years, family member is not currently pregnant, and family member has a cell phone with 
SMS text message capability. Exclusion criteria is family member has a terminal illness. Once the form 
is completed if the caregiver meets the inclusion criteria, the caregiver will receive an informed consent 
form. The research team will use a stratified randomization method to enroll eligible participants into 
the study. Participants will be stratified to research arms based upon enrolling family member’s BMI 
and child’s BMI measured at the time of randomization. Only the study team will recruit potential study 
participants during regular clinical care or follow-up calls from participant initiated inquiries.  
Recruitment will continue at each of the selected clinic sites until a 71 caregivers per research arm are 
included in the program, which will take approximately 6 weeks based on the previous experience of 
the number of caregiver clinic visits per clinic day. The study closure will be marked by a live or virtual 
community celebration. Community partners have served as a platform currently with the Pediatric 
Mobile Clinic over 4 years to inform families of the resource available to them through the Pediatric 
Mobile Clinic. The community partners will continue to refer pediatric patients and their caregivers to 
the services provided by the Pediatric Mobile Clinic and will not provide any information to caregivers 
regarding the research study but may post or distribute the research flyer to allow families to contact 
the Pediatric Mobile Clinic directly. No recruitment will occur at the community celebration event. The 
recruitment materials used in this study will be the study flyer. 
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ii. Participant Informed Consent Form 
During the recruitment period, each participant who met the inclusion criteria will be provided with the 
consent letter to read and the Research Assistant will read in English to help the participants achieve 
full understanding. The consent form and HIPPA form will outline the benefits and any potential risks 
that may ensue because of taking part in the study. Once the participants have had the opportunity to 
read and understand the forms and ask questions to the research team, the participants who agree to 
be in this study by completing the informed consent form and HIPPA form will then be enrolled in the 
“E-health Family Central” program. Participants will be instructed to follow-up with their primary care 
providers if their clinical tests are cause for concern.
iii. Instrumentation 
Surveys will be the key instrument in this study to assess health knowledge, attitudes, and behaviors 
toward the selected six topics. The surveys are adopted from the American College of Lifestyle 
Medicine (ACLM, 2015). Surveys will also contain questions to assess demographic characteristics 
(e.g. gender, race, zip code). The instruments will be prepared in English. Clinical outcomes that will be 
measured include blood pressure, height, weight, Body Mass Index (BMI), waist circumference, total 
cholesterol, and blood glucose tests will be measured. In the event that study procedures will move to 
virtual settings, participants will provide their self-report of most recent blood pressure, total 
cholesterol, and blood glucose test if known. Participants will not be excluded if they are unable to 
provide a historical blood pressure, total cholesterol, or blood glucose test result. BMI will be calculated 
as (kg/m2).
iv. Data Collection
As to the survey of knowledge, attitudes, and behaviors, at enrollment (baseline), the participants will 
be asked to complete self-administered questionnaire regarding the six healthy lifestyles. Then, during 
the six-month intervention, participants will receive text messages at intervals set by their preference 
but at least 2 times per week to ensure adequate space for education delivery and assessment through 
Likert scale text message surveys relating to Lifestyle Health Education. As to the clinical outcomes, 
self-reported blood pressure, blood glucose, total cholesterol, waist circumference, and body mass 
index (BMI) will be collected from the participants at enrollment and at the live or virtual community 
celebration at the close of “E-health Family Central”.  The study will occur from June 2020 to 
December 2020. There will be no monthly meetings or sessions. All information is relayed 
electronically.
2) Data Analysis and Data Monitoring - Describe plans for statistical analysis of data when appropriate. If a 
data safety monitoring committee is appropriate to protect the safety and/or welfare of subjects, describe 
its operation (e.g., membership, stopping rules and frequency of review).  
Data will be analyzed using SAS 9.4 for Windows. To examine the equality of the two groups, baseline 
sociodemographic and clinical variables will be compared using chi-square or t-tests depending on the 
level of measurement. Randomization should ensure equal distribution between the two groups of 
potentially confounding characteristics. However, baseline variables will be used as factors or 
covariates as appropriate in subsequent analyses. Descriptive statistics (mean ± SD, median with 
interquartile range or percentage) will be reported to characterize changes in the variables. The 
statistical analysis will be based on the outcomes, percent change in attitude/knowledge, over the 
study period. The general method entails an initial analysis that will employ the t-test (or Wilcoxon rank 
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sum test if non-normality is observed) to compare the outcomes between the two groups. Next, 
univariate linear regression models will be constructed for each outcome examining the effects of
any variable observed to be different between the two groups at baseline. Subsequent analyses of the
outcomes on the differences between time points (baseline to 6 months, baseline to 12 months), will 
involve multiple linear regression, in which the primary predictor variable is group, and any of the 
factors found to be significant in the univariate regressions, and potential interactions. Finally, 
longitudinal data analysis will be performed on each outcome using generalized linear equations. This 
analysis will measure changes over time (baseline, 6 months and 12 months) between the two groups. 
Comparisons will be made, using this model, between different time points within each group as well 
as between the two groups. This analysis will be able to identify at which point, if any, the break in 
improvement between the two groups occurs. This approach will apply to all hypotheses since in each 
the outcome is a continuous variable. 
a. Power Analysis
Due to the complexity involved in power calculations for mixed models, sample size calculations are 
based on a linear model assumption. Using G-Power Sample Size Calculator, with an assumption of a 
conservative effect size (f) of 0.15, a power of 0.8 for testing the hypothesis of whether there is an 
effect of the intervention at α=0.05, we will need a sample size of at least 55 participants in the study. If 
we increase our power to 0.9, we would need a minimum of 73 participants.
3) Data Storage and Confidentiality – Describe where the research data will be stored during the study and 
how it will be secured. The investigator must take necessary steps to maintain confidentiality of data. This 
includes coding data and choosing an appropriate and secure data storage mechanism, which will 
prevent unauthorized access to data. State who will have access to the data. If data with subject 
identifiers will be released, specify the person (s) or agency to whom the information will be released and 
the purpose of the release. 
All study-related materials and documentation will only be accessible to the study personnel. 
Completed questionnaires will be placed into locked file cabinets in the office of the PI. Clinical 
outcomes recorded through a shared Microsoft excel drive will only be accessible to key study 
personnel. Although there is a potential risk for breach of confidentiality, all study personnel will be 
trained in accordance to Health Insurance Portability and Accountability Act of 1996 (HIPAA) to 
maintain privacy and confidentiality as completely as possible to prevent this occurrence.  Data 
from the Pre-Screening form will be kept securely and data for those potential participants that were 
not eligible will be securely destroyed per all federal and institutional policies/guidelines.  Research 
data, in hard copy or electronic form (CDs, DVDs, digital or magnetic tape, hard‐drives, flash‐
memory drives, etc.) will be stored and managed in a secure manner following federal guidelines 
and according to state and institutional policies and practices. Further, research documents 
including electronic documents containing subject data, identifiers and linked data will be securely 
stored in locked containers (file cabinets, lockers, drawers, etc.) in accordance with standard 
document management practices. At all times, only listed key personnel specifically designated and 
authorized by the Principal Investigator shall have access to any research related documents. All 
such personnel will be properly trained and supervised regarding the management and handling of 
confidential materials. The Principal Investigator assumes full responsibility for such training, 
supervision, and conduct.
4) Setting - Describe briefly where the study will be conducted, e.g., private outpatient clinics, physicians’ 
offices. 
The study will be conducted through the Pediatric Mobile Clinic during visits to community sites in 
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Fort Worth: Morningside, North Side, and Stop Six or virtually through contact with the Pediatric 
Mobile Clinic research team.
NOTE: If other institutional review committees (IRBs) or approvals are required, note them by name, 
affiliation and contact person. Also, be aware that the approval of other institutions’ IRBs must be 
obtained before initiation of the project (but are not essential for North Texas Regional IRB review to 
begin). 
5) Laboratory methods and facilities - Indicate where specific laboratory tests will be performed; e.g., 
hospital chemistry laboratory, investigators' laboratory, radiology clinic, etc. If None, state N/A 
Participants will self-report historical blood sugar and total cholesterol testing. 
6) Estimated Period of Time to Complete the Study – Describe the stages and total time of subject 
participation as well as overall time for the entire study (start to completion).  Also, if study involves more 
than one visit, describe time range estimates for each visit (e.g., 20-30 minutes; 2 – 3 hrs, etc.). Where 
possible, use a table or “bullet-point” format to clearly illustrate the flow of activities and procedures. 
The study will consist of one recruitment/enrollment 20-30-minute visit, one group meeting lasting 
60 minutes to close the study, and 6 months of text message briefs on either 1) health education 
available to through the patient portal of the electronic medical record for their child or 2) six topics: 
nutrition, physical activity, sleep, tobacco avoidance, stress management, and social connection.  
Each week participants will receive text messages at intervals set by participants’ preference but at 
least 2 times per week to include survey assessment and delivery of health lifestyle education 
briefs. The 6-month study will start upon receiving the IRB approval, followed by a few months of 
data analysis and management as well as organizing and publishing the results.
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Family members recruited during visit to Pediatric Mobile Clinic over 4-6 week period
Family members screened with paper registration & screening forms by the PI or Research Assistant
If eligible to participate, consents are completed
BMI for Family member/child along + biometric measurements for enrollee then family is stratified and randomized to either control or intervention arm
E-health text Intervention arm begins baseline data collection (n=71)
Control group arm receives welcome text with link to patient portal for electronic health re
Weekly text delivered for health education briefs according to 6-week topic cycle
Weekly text delivered with reminder of access to electronic versions of patient handouts pro
Data collection according to schedule in table 1 +SMART goal submitted and stage of change determination
SMART goal submitted
Linking to community resources based upon SMART goals
Fig. 3 Study Work flow
F. Human Subjects - Describe the characteristics of the research population: 
1) Sample Size: Number of subjects to be enrolled in this study at this site. Approximately _142_ subjects at 
_3 community___ sites in Fort Worth will be enrolled in the study overall. 
2) Describe both Inclusion AND Exclusion Criteria. BE SPECIFIC!  Also, if children (persons under age 18) 
are excluded from this study provide scientific justification for such exclusion.  Include physical, mental, 
cognitive, medical, and other relevant Inclusion and Exclusion criteria. 
Self-selection approach will be used to recruit the participants in the study based on the following 
criteria 1) Adults aged 18 years and over; and 2) Primary caregiver of previous or current Pediatric 
Mobile Clinic patient with a medical diagnosis of overweight/obese, defined as BMI percentile of 
85% or above 3) Age of child is 6 months to 11 years old.
The exclusion criteria will be 1) individuals who are younger than 18 years of age; 2) Individuals 
who are not caregivers of a previous or current Pediatric Mobile Clinic patient; 3) Individuals with 
severe or terminal illness; 4) non-English speaking individuals 5) Women who are pregnant
3) Describe intended gender, age range, intended racial and ethnic distribution. If any vulnerable subjects 
are involved in this study (e.g., those with limited autonomy or decision-making capabilities), justification 
must be provided. 
No vulnerable subjects will be recruited. Adults aged 18 years and over. Participants will most likely 
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be racial/ethnic minorities, but that is not a requirement.
4) Identify the source(s) from which you will obtain your study population. 
The source population comes from caregivers (parents, grandparents, etc.) of previous or current 
Pediatric Mobile Clinic patients.
5) Describe plans for recruitment of subjects. All materials (e.g., flyers, ads, emails, letters, postings, 
handouts, etc.) to be used for recruiting subjects must be submitted to the IRB for review.
Participants will be recruited individually among the caregivers of pediatric patients from the mobile 
clinic during regularly scheduled clinic days or through virtual participant initiated contact with the 
Pediatric Mobile Clinic research team from distributed research flyers, which will lead to verbal 
introduction of the research project and provision of the pre-screening form. 
G. Risk/Benefit Assessment 
1) Describe the level of risk, and if more than minimal, describe how this research holds the prospect of a 
direct benefit for the subjects. If there is NO direct benefit to subjects, state such in protocol and in the 
consent documents. 
Risk is minimal and may include finger prick lab testing while enrolling in “Family Central” and the 
survey administration. Subjects may decline the testing or forfeit their survey responses at any time. 
All participants will engage in the study with non-web- based, two-way SMS text messaging via 
their personal cell phone. Data will not be used to participate. However, SMS text messages will be 
used and participants will be responsible for any SMS text message charges with their phone 
carrier. Participants are encouraged to contact the researchers if they feel any discomfort during the 
health education and survey process. Furthermore, all staff will be adequately trained to ensure the 
participants’ privacy and confidentiality and has undergone CITI training.
2) Describe how the anticipated benefit justifies the risk. 
The possible benefits of the study are participants may learn more about healthy eating, improved 
physical activity, limiting or avoiding tobacco intake, improved sleep patterns, adequate stress 
management, and better social connection, which can improve the overall health of the study 
participant. Receipt of lab values is also a potential benefit for study participants.
3) Describe how the anticipated benefit of this research is at least as favorable to the subjects as that to be 
received by available alternative approaches for the subjects. 
The possible benefits of the study are that participants will learn their cardiovascular and diabetic 
health risks. Lastly, participants will learn of community resources that can support healthful living.
4) Describe any potential RISKS OR DISCOMFORTS in detail. Use evidence from clinical and/or animal 
studies to evaluate the level of potential hazards associated with participation in the research protocol. 
Indicate the methods for detecting adverse reactions. Describe the procedures for protecting against or 
minimizing potential risks (e.g., confidentiality, reputational injury, direct injury or harm to subject, etc.) 
and assess their effectiveness. Discuss why the risks to the subjects are reasonable in relation to 
proposed benefits to humanity. Be sure to describe any anticipated adverse events that might occur 
during the course of the study.
All study-related materials and documentation will only be accessible to the study personnel. 
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Completed questionnaires will be placed into locked file cabinets in the office of the PI. Clinical 
outcomes recorded through a shared Microsoft excel drive will only be accessible to key study 
personnel. Although there is a potential risk for breach of confidentiality, all study personnel will be 
trained in accordance to Health Insurance Portability and Accountability Act of 1996 (HIPAA) to 
maintain privacy and confidentiality as completely as possible to prevent this occurrence.
Risks may include finger prick lab testing while attending “Family Central” and the survey 
administration. Subjects may decline the testing or forfeit their survey responses at any time. 
Participants are encouraged to contact the researchers if they feel any discomfort during the health 
education and survey process. Furthermore, all staff will be adequately trained to ensure the 
participants’ privacy and confidentiality.
H. 
Payment/Compensation - Describe any financial payments for subject participation (e.g. compensation 
for time and travel). Indicate any partial payment schedule for less than complete study participation. Recall that 
payments cannot be perceived as coercive (overpayment for time and effort). Remember: payments are NOT 
benefits. 
Grocery tote bags will be provided to participants enrolling in person. Weight scales and tape 
measures will be provided to all participants. Each participant will be compensated $25 for 
participation in all study components: enrollment, study intervention, and closing live or virtual 
community celebration.
I.
Subject Costs - Describe any anticipated costs to research subject. If none, state such.
None
J. List of KEY PERSONNEL. List all individuals directly involved in the conduct, design or reporting of 
research involving human subjects in this study, including anyone who may be consenting subjects.  This 
list will include the Principal Investigator, Co-Investigators, collaborating investigators, study coordinators, 
etc. 
PI – Dr. Christina Robinson will be backup study team member to perform a finger prick using 
lancets to draw blood for point of care testing of glucose and cholesterol testing.
Co-I – Dr. Maya Nair provided Lifestyle Medicine Education brief content for text messages.
Collaborator – Debbie Gillespie will advise Lifestyle Medicine content for health education sessions.
Nurse – Connie Smith, LVN will perform a finger prick using lancets to draw blood for point of care 
testing of glucose and cholesterol testing.
Study Coordinator-Joseph Wascomb, participant recruitment
Data analysis and Data collection- Laura Kade, Rebecca McDonald, Benjamin Trammell, Michael 
Kranz, Makenzie Bender, Debini Banh, Aimee Lopez, Fatima Abed, Sheena Ghalla, Jenny Thai, 
Kavita Patel, and Rumaila Hussain will assist
Study coordinator – Joanna Garcia, MPH will coordinate IRB submission and offer administrative 
support for research study team.
Biostatistician: Andrew Yockey, PhD
K. Literature Cited – If any, the references should be limited to relevant and current literature pertinent to 
the proposed research. 
American College of Lifestyle Medicine (ACLM). 2015. What is Lifestyle Medicine?. Retrieved from 
https://www.lifestylemedicine.org/about
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Brewer, L.K. Moerbe, M.M., Janoski, N., Markham, M.S., Izaguirre, L., Kurian, A.K. (2012). Community 
health profile Tarrant County, 2005-2010. Retrieved from http://access.tarrantcounty.com/content/dam/
main/publichealth/PH%20DOCUMENTS/Epi/Community%20Assessments/TCCH_Profile_2005-
2010.pdf
Centers for Disease Control and Prevention. (2012). Preventing chronic disease: Eliminating the 
leading preventable causes of premature death and disability in the United States. Retrieved from 
https://www.cdc.gov/chronicdisease/pdf/Preventing-Chronic-Disease-508.pdf
Dhana, K., Haines, J., Liu, G., Zhang, C., Wang, X., Field, A. E., & Sun, Q. (2018). Association 
between maternal adherence to healthy lifestyle practices and risk of obesity in offspring: results from 
two prospective cohort studies of mother-child pairs in the United States. BMJ, 362, k2486.
Dickinson, H. O., Mason, J. M., Nicolson, D. J., Campbell, F., Beyer, F. R., Cook, J. V., & Ford, G. A. 
(2006). Lifestyle interventions to reduce raised blood pressure: a systematic review of randomized 
controlled trials. Journal of hypertension, 24(2), 215-233.
Johnston, C. A., & Moreno, J. P. (2014). Promotion of Long-Term Adherence to a Healthy Lifestyle. 
American Journal of Lifestyle Medicine, 8(4), 239-241.
Kent, L. M., Morton, D. P., Rankin, P. M., Gobble, J. E., & Diehl, H. A. (2015). Gender differences in 
effectiveness of the Complete Health Improvement Program (CHIP). Journal of nutrition education and 
behavior, 47(1), 44-52.
Pekmezi, D., Marquez, B., & Marcus-Blank, J. (2010). Health promotion in Latinos. American Journal 
of Lifestyle Medicine, 4(2), 151-165.
Tucker, C. M., Butler, A., Kaye, L. B., Nolan, S. E., Flenar, D. J., Marsiske, M., & Daly, K. (2014). 
Impact of a culturally sensitive health self-empowerment workshop series on health 
behaviors/lifestyles, body mass index, and blood pressure of culturally diverse overweight/obese 
adults. American journal of lifestyle medicine, 8(2), 122-132.
Tucker, C. M., Smith, T. M., Wippold, G. M., Whitehead, N. E., Morrissette, T. A., Williams, J. L., ... & 
Crosier, B. S. (2016). Impact of a University-Community Partnership Approach to Improving Health 
Behaviors and Outcomes Among Overweight/Obese Hispanic Adults. American Journal of Lifestyle 
Medicine, 11(6), 479-488.
Whitaker, R. C., J. A. Wright, M. S. Pepe, K. D. Seidel, and W. H. Dietz. 1997. 'Predicting obesity in 
young adulthood from childhood and parental obesity', New England Journal of Medicine, 337: 869-73.
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IRB Protocol Synopsis Format Instructions rev. November 2018            
 
Approval Date: October 12, 2022