Reducing Health Disparities Through an Adaptive Healthy Eating Program for Underserved Infants in a Home Visiting Program
Phase: NA
Conditions: Pediatric Obesity
Sponsor: University of Cincinnati

 
 
 
 
 
 
 
 
 
 
Reducing Health Disparities Through an Adaptive Healthy Eating Program for 
Underserved Infants in a Home Visiting Program (Healthy Eating for My Infant; HEMI) 
NCT04977947 
4/17/2023

 
 
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Instructions:  
1. Complete all sections of the protocol template. By clicking on headers in the Table of Contents 
below, the form will navigate you directly to that section. 
2. If a section does not apply, list Not Applicable as advised. 
3. Refer to documents, templates, checklists, SOPs, and worksheets as advised throughout the 
protocol in Blue. Each document referred to in blue contains a hyperlink to the RAP library to 
obtain the documents (CONTROL + CLICK) 
4. Please ensure that your RAP Profile is up to date with your correct email address, phone number, 
and a current CV/Resume. 
5. Upload this completed document into a New Study Submission in RAP 
(https://rap.irb.uc.edu/irb), on the Basic Information Page under “Protocol”.   
TABLE OF CONTENTS 
1.0 OBJECTIVES ................................................................................................................................................. 3 
2.0 BACKGROUND............................................................................................................................................. 4 
3.0 RESOURCES AVAILABLE .............................................................................................................................. 8 
4.0 INVESTIGATOR EXPERIENCE ....................................................................................................................... 9 
5.0 STUDY ENDPOINTS .................................................................................................................................... 10 
6.0 PROCEDURES INVOLVED .......................................................................................................................... 10 
7.0 DATA AND SPECIMEN BANKING ................................................................................................................ 15 
8.0 SHARING OF RESULTS WITH SUBJECTS .................................................................................................... 15 
9.0 STUDY TIMELINES ...................................................................................................................................... 15 
10.0 INCLUSION AND EXCLUSION CRITERIA & VULNERABLE POPULATIONS ................................................. 16 
11.0 NUMBER OF SUBJECTS ............................................................................................................................ 17 
12.0 RECRUITMENT METHODS ........................................................................................................................ 17 
13.0 COMPENSATION FOR SUBJECTS ............................................................................................................. 18 
14.0 WITHDRAWAL OF SUBJECTS ................................................................................................................... 19 
15.0 RISKS TO SUBJECTS ................................................................................................................................. 19 
16.0 POTENTIAL BENEFITS TO SUBJECTS ........................................................................................................ 20 
17.0 DATA MANAGEMENT AND CONFIDENTIALITY .......................................................................................... 20 
18.0 PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS ......................................... 22 
19.0 PARTICIPANT PRIVACY ............................................................................................................................ 24 

 
 
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20.0 COMPENSATION FOR RESEARCH RELATED INJURY ................................................................................ 24 
21.0 ECONOMIC BURDEN TO SUBJECTS ......................................................................................................... 24 
22.0 CONSENT ................................................................................................................................................ 25 
23.0 CONSENT PROCESS ................................................................................................................................ 26 
24.0 WAIVER OF DOCUMENTATION OF CONSENT .......................................................................................... 29 
25.0 WAIVER OR ALTERATION OF CONSENT PROCESS ................................................................................... 30 
26.0 CONSENT OF NON-ENGLISH-SPEAKING SUBJECTS ................................................................................ 31 
27.0 CONSENT OF SUBJECTS WHO ARE NOT YET ADULTS (infants, children, adolescents) ........................... 32 
28.0 CONSENT/ASSENT OF COGNITIVELY IMPAIRED ADULTS ........................................................................ 33 
29.0 HIPAA ...................................................................................................................................................... 33 
30.0 STUDY INTERVENTION/ INVESTIGATIONAL AGENT ................................................................................. 33 
31.0 ADDITIONAL REVIEWS AND CONSIDERATIONS ...................................................................................... 35 
32.0 REGULATORY OVERSIGHT ....................................................................................................................... 36 
33.0 SETTING ................................................................................................................................................... 36 
34.0 EXTERNAL LOCATIONS ............................................................................................................................ 37 
35.0 REFERENCE LIST ...................................................................................................................................... 39 
 
STUDY SUMMARY: 
PROTOCOL TITLE: 
Reducing Health Disparities through an Adaptive Healthy Eating Program for 
Underserved Infants in a Home Visiting Program 
PRINCIPAL 
INVESTIGATOR: 
Cathleen Stough, PhD 
VERSION 
NUMBER/DATE: 
Version 1, 7/17/2020 
SHORT TITLE: 
Reducing Health Disparities through an Adaptive Healthy Eating Program for 
Underserved Infants in a Home Visiting Program)  
RESEARCH 
INTERVENTION(S)/ 
INVESTIGATIONAL 
AGENT(S): 
Behavioral intervention 
IND/IDE #: 
Not Applicable 

 
 
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STUDY SPECIFIC 
ABBREVIATIONS/ 
DEFINITIONS: 
HEMI: Healthy Eating for My Infant; ECS: Every Child Succeeds; GLA: group-level 
assessment; SES: socioeconomic status; BMI: body mass index; CCHMC: Cincinnati 
Children's Hospital Medical Center; IRB: Institutional Review Board; ISM: 
independent safety monitor 
FUNDING SOURCE 
National Institute of Nursing Research 
FUNDING LOCATION 
☒ 
Funds are held in Sponsored Research Services for a Grant or 
Contract (funds are held internally at UC) 
☐ 
Funds are from a department account (held internally at UC) 
☐ 
Funds held in a corporate account from a Contract (funds held 
externally from UC) 
☐ 
No funding 
 
PROTOCOL: 
1.0 OBJECTIVES 
1.1 Describe the purpose, specific aims, or objectives. 
This study seeks to develop and test an adaptive, empirically-supported, culturally and 
contextually relevant infant obesity prevention program (Healthy Eating for My 
Infant, HEMI) developed in partnership with the community. HEMI targets healthy 
eating among infants who are at risk for health disparities and obesity starting at 3 
months of age. HEMI will be delivered through home visits in conjunction with an 
existing home visiting program, Every Child Succeeds (ECS), and will involve 
community members and key community stakeholders in the design and delivery of 
the program. HEMI utilizes a behavioral and educational approach targeting problem 
solving to overcome barriers, behavioral rehearsal and practice of healthy behaviors, 
promoting readiness to change, goal setting, self-monitoring, and behavioral tracking. 
HEMI will be tailored to meet the needs of individual families; two standard treatment 
modules will be provided to each family by a study interventionist focusing on infant 
nutritional requirements, responsive feeding, and mealtime behaviors. Two additional 
treatment modules will be selected to address the unique needs articulated by each 
family (e.g., food insecurity, eating healthy on a limited income, emotional eating, 
engaging other caregivers, maternal mental health). Modules will also consider the 
influence of maternal trauma history and mental health on feeding and eating 
behavior, given the known high prevalence of these risk factors among families in 
ECS. HEMI also includes two peer counselor-led sessions during which families can 
discuss implementation of recommendations and barriers to change with a member of 
their community who can problem solve and support change.  
Aim 1: Collaboratively develop the content and design of the HEMI program through 
a community- engaged group-level assessment (GLA) qualitative methodology 

 
 
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involving stakeholders in a home- visiting program serving at-risk youth and their 
families. 
Aim 2: Examine whether the HEMI program, a 6-month personalized obesity 
prevention program for infants, is effective and acceptable/relevant for families 
receiving home visiting services.  
 
1.2 Describe the hypotheses to be tested. 
We hypothesize that families and peer counselors involved in delivery of the program 
will find the treatment appropriate, satisfactory, relevant, and helpful as rated on a 
treatment satisfaction questionnaire, post-treatment debriefing interviews, and 
measurement of treatment completion rates. We also hypothesize families receiving 
the program (n = 15) will have a lower proportion of infants with BMI > 85th 
percentile compared to infants in control families who receive standard ECS content 
only (n = 15). Secondarily, differences in child diet between the treatment and control 
group will be examined. 
 
 
2.0 BACKGROUND 
2.1 Describe the relevant prior experience and gaps in the current 
knowledge. 
Pediatric obesity poses significant health risks across the lifespan and 
disproportionately affects youth from low-income or underrepresented racial and 
ethnic backgrounds (1, 2). Youth from underserved populations experience increased 
morbidity and mortality secondary to pediatric obesity (3). Infancy and early 
childhood provide an ideal window for prevention given this is a time of rapid growth 
with lasting metabolic and behavioral consequences (4). However, few infant obesity 
prevention programs target obesity-related health disparities in underserved 
populations (5). Home visiting programs offer an avenue for overcoming accessibility 
barriers to provide services for underserved, low-income, or racial and ethnic minority 
families. Home visiting programs targeting obesity prevention have been successful in 
improving some isolated obesity-risk factors (6) but have not been able to achieve an 
overall positive impact across obesity-risk factors, reductions in high weight-for- 
length (7), or long-term outcomes. This may be the result of programs offering 
standardized treatment content that is not adapted to the specific needs of each 
individual family and that is not contextually and culturally relevant. Development of 
pediatric obesity is complex with unique factors and circumstances influencing risk of 
each individual (8, 9). For example, trauma-history is known to significantly impact 
feeding and eating behaviors through a number of both physiological and behavioral 
pathways, but few obesity programs directly target this complex risk factor (10). 
Given the complex barriers to healthy lifestyles among underserved populations, 

 
 
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development of a program to address these unique needs requires involvement of the 
community that the program is intended to serve rather than simply relying on work 
that has been done with other populations. Obesity prevention programs for at-risk 
underserved infants tailored to the specific barriers to healthy eating and feeding for 
individual families have not been developed. 
 
2.2 Describe any relevant preliminary data.  
Not Applicable 
2.3 Provide the scientific or scholarly background for, rationale for, and 
significance of the research based on the existing literature and how it will 
add to existing knowledge.  
There are significant health disparities in obesity prevalence, which is a national 
epidemic impacting nearly 20% of U.S. youth (12). Hispanic youth (23.6%) and non-
Hispanic black youth (20.4%) are at greater risk than their non-Hispanic white 
counterparts (14.7%; 13). Obesity rates are nearly double for youth whose caregiver 
has a high school diploma or less (22.3%) compared to youth whose caregiver is a 
college graduate (11.6%). Obesity also disproportionally affects youth in households 
with lower incomes, although this relationship differs across population subgroups 
(e.g., race/ethnicity, sex; 14). The pathway to obesity begins in infancy meaning that 
prevention programs during toddlerhood and the preschool years may already be too 
late to address the earliest risk factors for obesity. Youth who go on to develop severe 
obesity begin to deviate from their normal- weight peers in their growth trajectories by 
4-6 months of age (15). Body Mass Index (BMI) ≥ 85th percentile at 6 and 12 months 
is a strong predictor of subsequent obesity (15). Infants with elevated BMIs have the 
greatest cumulative incidence of obesity in adulthood (16).  
The ecological model of childhood obesity posits that child factors (e.g., diet), family 
factors (e.g., feeding practices, home food environment), and community factors (e.g., 
socioeconomic status [SES], access to healthy food) are all contributory to childhood 
obesity (8). Early feeding and eating behaviors are the health behaviors that have most 
consistently been implicated in obesity risk in infancy, while research on the relation 
between sleep, physical activity, and screen time in infancy and obesity risk has 
provided a less consistent picture (17). Early feeding and eating behaviors that 
increase future obesity risk include inappropriate bottle feeding, beverage intake, 
protein intake, early introduction of solid foods, parental feeding practices (e.g., 
restrictive parenting practices), parental modeling of healthy eating, and early diet 
variety (17-20). Infants from families of low SES display greater rates of these early 
unhealthy eating patterns and elevated growth trajectories, meaning health disparities 
in obesity risk start during infancy (21, 22). Children from racial and ethnic minority 
groups display more rapid weight gain, earlier introduction of solid food, and higher 
rates of maternal restrictive feeding practices during infancy compared to their non-

 
 
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Hispanic white counterparts (23). The Institute of Medicine’s Committee on Obesity 
Prevention Policies for Young Children put forth targets for reducing childhood 
obesity based on known risk factors including: promoting the consumption of a variety 
of nutritious foods, encouraging and supporting breastfeeding during infancy, creating 
a healthful eating environment that is responsive to children’s hunger and fullness 
cues, and helping adults to increase children’s healthy eating (24).  
Despite the importance of obesity prevention during infancy, few programs target this 
age group (n = 18), and less than half of those (n = 7) are effective (25). Effective 
programs to date have addressed maternal and family health behaviors, infant feeding, 
infant physical and sedentary activity, infant sleep, and formula supplements.25 The 
effectiveness of these programs does demonstrate that early child growth trajectories 
are amenable to change and that these changes can be maintained long-term (26). 
While there are very few effective infant obesity prevention programs in general, there 
are even fewer programs that are accessible and relevant for infants in underserved 
minority groups who are at-risk for health disparities.  
Home visiting is an avenue for delivery of programs targeting young children from 
underserved, at-risk, and low SES populations by overcoming many of the barriers 
that contribute to disparities in healthcare access and service (27). Most home visiting 
programs employ a curriculum focusing on effective parenting, infant safety and 
health, developmental milestones/kindergarten readiness, and ensuring connections to 
community resources. While some home visiting programs targeting obesity 
prevention in at-risk underserved preschoolers have been developed (28-31) a need for 
such programming for underserved infants remains (27). Early efforts to provide 
obesity prevention programs via home visiting have been somewhat successful. The 
Early Childhood Obesity Prevention Program (ECHO; 6) targeted early obesity risk 
factors in infancy (e.g., diet, sleep, breastfeeding, and activity) through intervention 
sessions utilizing a maternal skills-based and behavioral approach involving building 
connections to community resources. ECHO was successful in improving 
breastfeeding and some sleep outcomes. Similarly, a home visiting program among 
high-risk Native-American infants and toddlers was effective for reducing child 
weight, energy intake, and restrictive feeding practices (32). The Intervention Nurses 
Start Infants Growing on Health Trajectories (INSIGHT) program also used home 
visits to target responsive feeding and effectively reduced weight gain and BMI (33). 
However, there is a significant gap in utilization of home visiting programs as a means 
of delivering primary obesity prevention programs. Only 17% of home visiting 
programs for young children address infant or child feeding cues, only 11% address 
complementary foods, and only 6% address diet variety, vegetable intake, eating 
dysregulation and fussiness, portion sizes, or healthy snacks (34).  

 
 
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While home visiting infant obesity prevention programs have resulted in change to 
some specific obesity-risk factors, a broad impact on other crucial outcomes, such as 
infant weight-for-length or other diet variables, has been lacking. For example, ECHO 
(6) did not impact diet beyond breastfeeding or infant weight, and the reductions in 
BMI found by the INSIGHT program were only modest and BMI percentiles did not 
differ between the treatment and control group (33). The relative ineffectiveness of 
many current infant obesity prevention programs may be because they implement a 
one-size-fits-all approach rather than tailoring content to the unique barriers to health 
for specific families, including families from underserved, at-risk, and low SES 
groups. For example, current obesity prevention programs in infancy have generally 
failed to explicitly address the complex influence of trauma history and mental health 
on eating and feeding behaviors. This is despite several possible pathways between 
trauma, stress, and obesity-risk (e.g., emotional eating and overeating, changes to 
reward and regulatory neural circuits, changes to endocrine processes related to 
appetite regulation, role of gut microbiome; 10). Programs targeting maternal healthy 
eating behaviors among low-income families have found trauma-experiences to be a 
barrier for mothers (35). There is a need for individualized obesity prevention 
programs for infants that are culturally and contextually relevant for families in 
underserved and minority groups. Low-income mothers participating in Women, 
Infants, and Children (WIC) have reported dissatisfaction with the use of a one-size-
fits-all approach to dietary and feeding guidance (36). Obesity programs are not often 
tailored to the needs of underserved populations and fail to involve members of the 
community in design and delivery of treatment, which may be why children from 
ethnic and racial minority groups, low-income homes, or other at-risk groups 
demonstrate poorer outcomes (37, 38) and attrition rates (39-43).  
Prior research has under-utilized community-engaged approaches to infant obesity 
prevention. Methods that incorporate community members into all phases of project 
implementation allow increased communication, transparency, and trust between 
academia and the community. This partnership can increase participant engagement, 
community ownership of the project, understanding of community needs, and 
sustainability and dissemination of study results (44). Involving families from 
underserved groups in development of interventions improves the suitability of 
programming for meeting family needs, reduces attrition, increases recruitment, and 
improves patient outcomes (45-48). Adaptive interventions can enhance child 
outcomes by providing the information needed for that specific individual (49). 
Delivery of prevention efforts through home visiting programs that have prior 
established relationships with families also reduces the lack of trust and transparency 
that may prevent families from minority groups from receiving healthcare services. 
 
 

 
 
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3.0 RESOURCES 
AVAILABLE 
3.1 Describe the resources available to conduct the research. Justify the 
feasibility of recruiting the required number of suitable subjects within the 
agreed recruitment period, e.g. how many potential subjects do you have 
access to? What percentage of those potential subjects do you need to 
recruit? 
The current study is a collaboration between researchers at two institutional sites with 
a dedicated emphasis on research and scientific advancement and a long history of 
funding by the National Institutes of Health. UC and CCHMC have a long-standing 
history of research collaborations. These two institutions are located approximately 
one mile apart, making ongoing meetings and sharing of resources between these two 
institutions an ease. PI Dr. Stough and all graduate students in her research laboratory 
have also completed the badging/security process at CCHMC, easing their access to 
resources and facilities at CCHMC. Activities for the current study will be performed 
across UC and CCHMC campuses with primary administrative work, recruitment 
activities, data storage, and data management occurring at the UC campus.  
We do not anticipate difficulty with reaching adequate study enrollment given the 
number of eligible participants significantly exceeds the number of participants required 
for this pilot trial (i.e., approximately 400 families will enroll in ECS during the 6-month 
recruitment period and only 30 families are required for study enrollment). Our team has 
a successful track record of enrollment of ECS families into supplemental intervention 
trials. However, it is possible we may encounter participant attrition. We will take several 
safe guards to reduce attrition. All intervention and study visits will be conducted in 
participants’ homes to reduce barriers to attendance. Multiple methods for contacting 
families will also be obtained, including contact information for friends and family 
members who are likely to know the location of participants should they be temporarily 
out of contact. Regarding the GLA phase, GLA and action planning sessions will be 
scheduled at times likely to be convenient to participants, such as evenings and 
weekends, and if we encounter recruitment challenges, we could conduct multiple GLA 
sessions to meet participant availability.   
3.2 Describe the time that you will devote to conducting and completing the 
research, i.e. percent effort.  
PI will have 15% effort on this project. 
 
3.3 Describe the availability of medical of psychological resources that 
subjects might need as a result of an anticipated consequences of the 
human research.  
The intervention tested in this study (HEMI) is trauma-informed and includes trauma-
specific treatment components if participants have a significant trauma history. This is 
because stress and trauma can have a significant impact on feeding and eating, and we 
know rates of trauma are high in our target enrollment population. The research study 

 
 
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interventionists are graduate students in Clinical Psychology and trained in discussion 
and treatment of trauma. However, families may feel uncomfortable talking about these 
topics, and our research study can provide psychological referral resources if families 
would like that information.  
3.4 Describe your process to ensure that all persons assisting with the 
research are adequately informed about the protocol, the research 
procedures, and their duties and functions. 
All research staff involved in protocol activities will undergo training supervised by 
the PI. 
Interventionists for HEMI are advanced graduate students in Clinical Psychology who 
have extensive training and experience with handling confidential and sensitive 
information, and they will also receive training regarding working with individuals 
with a trauma-history pertaining specifically to this project. Peer counselors delivering 
the program will receive training regarding handling of confidential information and 
sensitivity in possible dual relationships where they may interact with participants in 
social or community settings. 
 
3.5 Describe the facilities you have access to that will allow you to conduct 
the 
research.  
The Healthy Kids Lab, directed by Dr. Stough, is located in the Psychology 
department at UC and adjacent to her office. The lab consists of 6 rooms totaling over 
1,000 sq. ft. The graduate and undergraduate research staff rooms of the laboratory 
include three new Dell PC desktop computers (i.e., purchased within the last three 
years). These computers are all equipped with statistical software (SPSS) and have the 
capability for remote access to other software (e.g., SAS, Mplus) through the UC 
virtual desktop. The PI also has a Dell Latitude 7370 and docking station with monitor 
located in her office. UC offers technical assistance on site, and the College of Arts 
and Sciences offers their own Technology Support Team to serve faculty and students. 
UC has a protected, internal server where electronic data files can be safely stored and 
backed up, allowing password-protected access to designated users.  
 
 
4.0 INVESTIGATOR 
EXPERIENCE 
4.1 Detail the investigators’ experience as it pertains to the study.  
Dr. Stough has a significant track record of research in the areas of child eating, 
feeding behaviors, and obesity-risk specifically among young children (e.g., infants, 
preschoolers), including a National Institutes of Health T32 Research Fellowship with 
training specifically in Child Behavior and Nutrition. Dr. Stough's extensive 

 
 
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background with development, delivery, and empirical evaluation of behavioral health 
interventions targeting weight management and healthy eating among children has 
given her the expertise necessary to develop and evaluate the intervention proposed in 
the current project. Specifically, among young children, she has developed a 
behavioral intervention targeting healthy introduction of solid foods to infants and has 
served as a clinician and researcher examining the effectiveness of multiple weight 
management programs targeting preschoolers. Dr. Stough has also served as a home 
visit interventionist for a weight management program tailored specifically for 
preschoolers and was principal investigator for a research study using home visits to 
examine mealtime behaviors among young children. Her general training and varied 
experiences in clinical child psychology have also led to my understanding of general 
child development, adjustment, and functioning, including the impact complex 
psychosocial situations can have on child development and behavior. 
 
 
5.0 STUDY 
ENDPOINTS 
5.1 Describe any primary and secondary study endpoints. 
The current project is projected to begin in January 2021 and data collection will last 
approximately 2 years. We anticipate the first Aim will begin in January 2021 and the 
second Aim involving delivery of the intervention will begin in June 2021.  
5.2 Describe any primary and secondary safety endpoints. 
Adverse events will be assessed throughout the study protocol. 
 
6.0 PROCEDURES 
INVOLVED 
6.1 Thoroughly describe the study design.  
The study consists of 2 aims. The first aim is a qualitative study design that will utilize 3 
visits to work with participants to get their feedback and ideas regarding development of 
a healthy eating intervention for infants. The second aim is a pilot randomized control 
trial utilizing a pre-post study design to assess efficacy and feasibility of a healthy eating 
intervention for infants.  
6.2 Detail the procedures being performed, specifically the interaction or 
intervention with human subjects and/or their identifiable information. 
Please be clear and concise and provide information relevant to the current 
study. For example, please be sure that what will be done for this research is 
explained and differentiated from activities that have already taken place or 
will be submitted for future review. Please note that details about 
recruitment and consent are asked in later questions. 
We recognize that the situation and risks of data collection are rapidly changing at this 
time related to COVID-19. Given some of our study procedures will not begin until 
June 2021, we will rely on following the safety precautions and protocols required due 
to the COVID-19 pandemic at that time. We will follow all requirements for in-person 

 
 
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research and recommended safety practices in place at the time of the start of this 
study. 
Aim 1: We will use Group Level Assessment (GLA), a structured, qualitative research 
method, to understand ECS caregivers’ needs, resources, and barriers to healthy infant 
eating and feeding, including the influence of trauma history. GLA is a participatory, 
large-group method which allows for diverse groups of stakeholders (in this case, ECS 
leadership, community partners such as WIC or community nursing agencies, home 
visitors, and mothers currently receiving ECS programming) from different 
backgrounds to engage in generating and evaluating data together. GLA is particularly 
appropriate where there may be a perceived hierarchy, such as between families and 
ECS board members, as it encourages minority opinions within a safely structured 
process. GLA will focus on development of participant-driven data and relevant action 
plans regarding how HEMI can be designed to benefit families. Data are 
collaboratively generated and interactively analyzed among the group itself, which has 
participatory and time sensitive advantages over other qualitative methods such as 
focus groups. Data are generated in GLA sessions through a 7-step structured process 
guided by a neutral moderator. Each participant will participate in 1 GLA session 
lasting approximately 2.5 hours. We will do three separate GLA sessions with 
approximately 15 participants per session; each participant will engage in only 1 GLA 
session. This session will be conducted remotely via telecommunication. Group 
members will be provided written prompts to stimulate ideas regarding healthy eating 
and feeding among infants and families, barriers to behavior change, needs of a 
program for ECS families, and the influence of trauma history on eating and feeding. 
Participants will provide written responses to these prompts. Participants will then 
spend time individually reacting to other participants’ responses and reflecting on the 
implications of the data. Next, major themes are identified based on responses within 
small groups of 5-8 participants. After the report out of themes, the large group will 
process the findings and begin to identify the most important themes. 
Participants from the GLA, community advisory board, and peer counselors will be 
invited to a session where themes and priorities co-identified will be used to develop 
an action plan for what content will be included in HEMI. This session will occur in-
person or through telecommunication depending on COVID-19 requirements and 
recommendations at the time of the study. The study team (led by PI Stough) will then 
refine standard modules and develop adaptive modules in response to the action plan. 
In a second action planning session, the study team will present the modules to the 
community stakeholders for comment and modification.  
Aim 2: Thirty families enrolling in the standard ECS program prenatally or shortly 
after birth will be recruited for a pilot trial of HEMI (15 control, 15 intervention). 
Participants will be infants and their mothers. We will recruit mothers of infants of 

 
 
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both sexes. Mothers will be specifically targeted (rather than other caregivers) because 
this is the population at the ECS program where we are delivering the intervention. 
ECS enrolls approximately 800 mother-child dyads per year, well exceeding our 
required sample size. ECS home visitors will refer all eligible pregnant participants to 
our research coordinators, who will contact each woman to schedule the first study 
visit. Inclusion criteria are: 1) child age 2 months at enrollment, 2) English or Spanish 
speaking, 3) maternal age > 18 years, 4) singleton, and 5) no major congenital 
anomalies or medical conditions requiring specialized feeding. Families will be invited 
to participate in this study in addition to standard ECS services and engagement in this 
study will not impact their ability to participate in the standard program. 1:1 
randomization to the control or treatment condition will occur at the time of the 
baseline visit.  
Participants will complete home-based baseline and post-treatment study visits when 
the child is 2 months and 9 months of age. Families randomized to the intervention 
condition will participate in six treatment sessions delivered as monthly 1-hour home 
or virtual visits based on the desires, interests, and needs of families, when the child is 
3, 4, 5, 6, 7, and 8 months of age in addition to participation in the standard ECS visits. 
Given the program’s target of behavior change and use of behavioral strategies, 
interventionist-delivered HEMI sessions will be provided by advanced clinical 
psychology doctoral students (supervised by a licensed clinical psychologist, PI 
Stough) accompanied by support staff. Two peer counselor-led sessions will be 
delivered as 1-hour home or virtual visits, based on the desires, interests, and needs of 
families and peer counselors, when the child is 5 and 8 months of age. Families in the 
control condition will receive the standard ECS content and complete baseline and 
post-treatment visits. 
 
6.3 Describe procedures being performed to monitor subjects for safety or 
minimize risks. 
Based on the size (n = 30) and complexity of the trial (e.g., unblinded trial) and the 
minimal risk of the study intervention to participants, this study will utilize an 
independent safety monitor (ISM) whose primary purpose will be to provide guidance 
regarding adverse events and safety issues. The ISM will be a medical expert (e.g., 
pediatrician, nurse) who is independent of the study and able to provide external and 
unbiased evaluation through consultation pertaining to safety issues. This person will be 
available in real-time on an as-needed basis should any concerns regarding adverse 
events or other safety issues arise. The ISM will be identified during the study start-up 
phase. The ISM will review relevant participant safety data and make recommendations 
regarding continuation, modification, or termination of the trial due to safety risk. 
Communication with the ISM will occur on an as-needed basis when safety concerns 
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The following potential adverse events will be assessed throughout the study period: 
occurrence of choking episodes during infant feedings (at each study visit and 
interventionist-led treatment session), growth faltering (monitored at each 
interventionist-led treatment session for infants in the treatment condition; length and 
weight will be monitored for all participants [i.e., treatment and control] at baseline and 
post-treatment), and unexpected adverse events. 
 
Study participants will be informed of any changes to the known risks and benefits of 
participating in the current study, including if it is identified that treatment participants 
are at greater risk for adverse events. If participants in the treatment arm experience 
greater adverse events, possible discontinuation of the study or modification of the 
intervention will be considered under the guidance of the ISM.  
6.5 Where applicable, list and describe the data collection tools such as 
surveys, data collection forms, etc. All tools described should be uploaded 
in the RAP Smart Form on the Local Site Documents page unless they are 
standardized, validated tools.  
Demographics Form. Participants in both the intervention and GLA methodologies 
will complete a demographics form. There is a separate demographic form for each of 
these methodologies because the interventionist participants will be asked additional 
demographic details about their participating child, while GLA participants will only 
report their own adult demographics.  
Maternal Feedback on Intervention: Maternal Feedback on the Intervention will be 
obtained through a quantitative survey and a qualitative interview. The quantitative 
survey consists of Likert scale ratings on whether they perceived the intervention as 
suitable, occurring at the right time, being presented clearly, and helpful; mothers will 
also rate satisfaction with the intervention and their confidence in implementing the 
recommendations made by the study team. Qualitative interviews will be conducted 
with each family by a research staff member who was not the study interventionist (to 
prevent potential bias) to obtain feedback regarding additional information that would 
be helpful to add to the program, content that was not helpful and could be eliminated 
from the program, other changes they would like to see to the program, and aspects 
they would like to see stay the same about the program. 
Peer Counselor Feedback on the Intervention: Interviews will be completed with peer 
counselors after all study participants have completed treatment. Open-ended 
questions will be asked such as: What aspects of the intervention did you feel were 
most helpful for families? What are additional things not currently offered in the 
intervention that you think could be helpful to families? Did you feel adequately 

 
 
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trained to provide the intervention? How do you feel participants utilized your role as 
a peer counselor? How could the peer counselor sessions be improved?  
Infant Anthropometrics: Infant weight and length will be measured in duplicate at each 
in person treatment and study visit using a mobile digital SECA baby scale and 
portable infant length board. The scale will be calibrated using a known weight, and 
will be zeroed prior to assessment. Infants will be weighed in a clean diaper without 
clothes. The length board has a stable headboard and a moveable foot board, and will 
be placed on a flat, hard surface. All length measurements will be taken using the right 
leg, with assistance from the mother as needed to hold the infant still while the right 
leg is extended flat and the foot flexed against the foot board. Weight measurements 
will be taken to the nearest 1.0 gram and length measurements to the nearest 0.5 cm. 
Infant BMI standardized for age and sex will be calculated from the WHO 2005 
growth standards. 
24-hr Dietary Recall Interviews: Infants’ dietary intake will be assessed via three 
random dietary recall interviews conducted by phone within +/-2 weeks of their 
baseline and post-treatment study visits. Trained interviewers from the Schubert 
Research Clinic Bionutrition Core, blinded to study condition, will employ the USDA 
automated multiple-pass method (AMPM), a standardized approach which has been 
shown to improve accuracy of dietary intake data collected (Moshfegh et al., 2008). 
Mothers will be provided ahead of time with visual aids to assist with estimating 
portion sizes during the telephone interview; visual aids will reflect age-appropriate 
foods, portions, and serving containers to facilitate reporting (Anater et al., 2018). 
Nutrition Data Systems for Research (NDSR; Nutrition Coordinating Center, 
University of Minnesota, Minneapolis, MN) software and foods database will be used 
to assess total daily energy and macronutrient intake as well as food group servings 
consumed. 
6.6 Describe all data that will be accessed and collected during the study 
and how that data will be obtained (how it will be accessed). 
The primary study measures listed above will all be collected for the purposes of this 
research study in accordance with the procedures outlined above. All research 
participants are also participants in the Every Child Succeeds home visiting program, 
and information from the ECS records may also be accessed. 
6.7 If there is a long-term follow-up plan (once all research related 
procedures are completed), what data will be collected during this period.  
There are no current plans for long-term data follow-up. However, this may be of later 
interest based on study outcomes, and therefore the consent form mentions the 
possibility that researchers may contact participants in the future about additional 
research.  
 
 

 
 
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7.0 DATA AND 
SPECIMEN BANKING 
7.1 If data or specimens will be banked for future use, describe where the 
data or specimens will be stored, how the data or specimens will be 
accessed, and who will have access to the data or specimens.  
We will retain identifiable information for 2 years after this research ends, to permit 
longer-term follow up. After that point, all identifying data will be destroyed, and only 
deidentified study data will be retained for future analyses. 
7.2 If specimens are being stored, list the data to be stored or associated 
with each specimen. 
Not Applicable 
7.3 Describe the procedures to release data or specimens, including: (the 
process to request a data/specimen release, approvals required for release, 
who can obtain data or specimens, and the data to be provided with the 
specimens. 
Data will only be available to members of the study research team. 
 
8.0 SHARING OF 
RESULTS WITH 
SUBJECTS 
8.1 Describe whether results (study results or individual subject results, 
such as results of investigational diagnostic tests, genetic tests, or 
incidental findings) will be shared with subjects or others (e.g., the subject’s 
primary care physician) and if so, describe the process for sharing. If you do 
not intend to share any results, please state that here. 
Results will not be shared with participants or any of their medical providers. 
 
9.0 STUDY 
TIMELINES 
9.1 Describe the duration of an individual subject’s participation in the study. 
List the number of study visits or frequency of study visits. 
For Aim 1, participants who participate in the GLA only will be in the study for 1 visit on 
one day. If participants choose to participate in the optional Action Planning session, 
they will do 2-3 
 
 visits over the course of approximately 2 months.  
For Aim 2, individual subjects will be in the study for approximately 8 months. Depending 
on randomization, participants will either complete 2-3 total visits at the beginning and 
end of the 8-month timeline or complete 8 monthly visits. 
9.2 Describe the timeline allotted for the enrollment of subjects. 
Subjects will be enrolled during the first year of grant funding. 
9.3 Describe the estimated date for the investigators to complete this study 
(complete primary analysis). 
Data collection for this study will span 24 months, with the projected start date of 
January 2021. Primary analysis will be completed within a year of the last data collected 
for the current project. 
 

 
 
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10.0 INCLUSION 
AND EXCLUSION 
CRITERIA & 
VULNERABLE 
POPULATIONS 
10.1 Describe how subjects will be screened for eligibility.  
For Aim 2, participants will be screened for eligibility via phone call from study staff prior 
to their baseline visit. 
10.2 Describe/list the inclusion/exclusion criteria for the study. 
Inclusion criteria for the GLA methodology are that the person is involved in the 
Every Child Succeeds home visiting program. This involvement will include a number 
of different roles such as board member, community partner, mother receiving service, 
former participant in the program, etc. Participants must also be either English or 
Spanish speaking.  
Inclusion criteria for the intervention methodology are: 1) child age 2 months at the 
time of the baseline study visit, 2) English or Spanish speaking, 3) maternal age is 
equal to or over 18 years, 4) singleton, and 5) no major congenital anomalies or 
medical conditions requiring specialized feeding. 
 
10.3 Indicate specifically whether you will include each of the following 
vulnerable populations. Check all that apply. (You may not include members 
of the below populations as subjects in your research unless you indicate 
this in your inclusion criteria and are approved by the IRB to include them in 
your research) The member checklists are for reference only to ensure you 
provide appropriate safeguards and justification. The checklists do not need 
to be completed.  
☐ 
Adults unable to consent (cognitively impaired individuals) (HRP-417 – 
MEMBER CHECKLIST Cognitively Impaired) 
☒ 
Individuals who are not yet adults (infants, children, teenagers) (HRP-
416 – MEMBER CHECKLIST Children) 
☐ Individuals who are not yet adults and are, or may become, wards of 
the state.  
☒ 
Pregnant women (a woman shall be assumed pregnant if she exhibits 
and of the presumptive signs of pregnancy, such as a missed menses, 
until the results of a pregnancy test are negative or until delivery.) (HRP-
412 MEMBER CHECKLIST Pregnant Women) 
☐ 
Non-Viable Neonates (HRP-413 – MEMBER CHECKLIST Non-Viable 
Neonates) 
☐ 
Uncertain Viability Neonates (HRP-414 – MEMBER CHECKLIST Uncertain 
Viability Neonates) 
☐ 
Prisoners (HRP-415 – MEMBER CHECKLIST Prisoners) 
10.4 If the research involves individuals listed in 10.3 or other individuals 
who are vulnerable to coercion or undue influence, please justify based on 

 
 
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the applicable checklist and describe additional safeguards included to 
protect their rights and welfare.  
Participants in the pilot testing of the HEMI program will be infants enrolled at 2 
months of age and their mothers. Our obesity prevention program specifically targets 
healthy eating between 3-8 months of age making it necessary for our study to include 
infants as the targeted population. All study staff have experience working with child 
populations, and the investigative team has significant experience in clinical care and 
research with children. Cincinnati Children’s Hospital Medical Center is a facility 
100% devoted to research and treatment of children, and PI Dr. Stough’s lab (i.e., the 
Healthy Kids Lab) was established specifically for research regarding children’s 
health. 
The Every Child Succeeds home visiting program provides services to families who 
are pregnant or with young children. Therefore, some Every Child Succeeds families 
who participate in the GLA phase may be pregnant women. 
10.5 If the research involves or may involve individuals who are students or 
employees where the research is taking place, please describe additional 
safeguards included to protect their rights and welfare. 
Not Applicable 
 
11.0 NUMBER OF 
SUBJECTS 
11.1 Indicate the total number of subjects to be accrued. 
For Aim 1, there will be no more than 100 participants. 
For Aim 2, we will recruit 30 infants and their mothers. 
11.2 If applicable, distinguish between the number of subjects who are 
expected to be enrolled and screened, and the number of subjects needed to 
complete the research procedures. 
Approximately 15 women enroll in the ECS program each week (~800 per year), providing 
a large sample pool from which to enroll participants. We anticipate that 50% (n=400) of 
eligible ECS mother-child dyads will be referred to the study (~7-8 per week). 
Participants will receive their enrollment visit when the child is 2-months of age. 
Informed by retention data from the ECS program, 85% (n=340) of the participants will 
remain active in the program when child is 2-months of age (criterion for eligibility). We 
anticipate 60% will agree to participate in the study (~4 per week).  
 
12.0 RECRUITMENT 
METHODS 
12.1 Describe when, where, and how potential subjects will be recruited. 
GLA Phase: Leadership, board members, community partners, and home visitors will 
be invited for involvement in the GLA through personal correspondence and 
advertising through standard ECS communications and meetings. Participating 
families will be informed about the study by ECS home visitors. Word-of-mouth and 
snowballing (i.e., one participant informing others who might be interested in the 

 
 
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assessment) will also be largely utilized. Prior to the start of the GLA session, 
participants will be provided with the required elements of consent. 
Intervention Pilot Testing: Participants will be families participating in the Every 
Child Succeeds (ECS) home visiting program. These participants will be recruited by 
ECS home visitors. Home visitors will refer eligible participants to our research 
coordinators who will contact families via phone to tell them more about the research 
study. Interested families will complete a screening over the phone with a study 
research coordinator to assess inclusion criteria. If a child meets inclusion criteria and 
the family is interested in participating, they will be scheduled for a first study visit. 
Because of the home visitor time it will take to complete referrals, we need to 
compensate them for their time. We will be paying home visitors or the agency 
employing home visitors $15 per each referral completed. Because this is 
compensation for their time and is not a finders fee, they receive $15 per referral even 
if the family says no and decides to not participate in the study or even if a family is 
not reached to further discuss the study. 
12.2 Describe the source of the subjects. 
Participants will be leaders, board members, community partners, home visitors, and 
families from the Every Child Succeeds (ECS) program. ECS was founded in 1999 and 
provides home visiting services to sociodemographically at-risk mothers in 
Southwestern Ohio and northern Kentucky. Mothers are eligible for participation if they 
meet at least one of 4 demographic factors: unmarried, low income, under the age of 18, 
and inadequate prenatal care. Administered by CCHMC, ECS has up to 3,000 families 
enrolled at any given time served by 115 home visitors in nine locally-embedded 
community agencies.   
12.3 Describe the materials that will be used to recruit subjects. (Attach 
copies of these documents in the Recruitment section on the local site 
documents page in RAP. For advertisements, attach the final copy of printed 
advertisements (avoid making copies until approved in case modifications 
are required). When advertisements are taped for broadcast, attach the final 
audio/video tape. You may submit the wording of the advertisement prior to 
taping to preclude re-taping because of inappropriate wording, provided the 
IRB reviews the final audio/video tape) 
For Aim 1, participants will be recruited through emails and word of mouth including use 
of the Recruitment Flyer uploaded in the RAP system. For Aim 2, recruitment will occur 
via verbal referral by ECS home visitors and will utilize IRB approved recruitment flyers.  
 
13.0 
COMPENSATION 
FOR SUBJECTS 
13.1 Describe the amount, method, and timing of payments to subjects.  
For Aim 1 (GLA), participants will earn $20 in gift cards for participating in each visit. 
Participants will have the option to be part of 1-3 visits, and so can earn up to a total of 
$60. 
 

 
 
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For Aim 2, participants will receive up to $100 for participating: $40 after participating in 
the baseline visit (when the infant is around 2 months of age) and $60 for completing the 
post-treatment visit (when the infant is around 9 months of age). We are providing this 
amount to participants through gift cards. At enrollment, participants will receive lab-
branded materials such as a notepad to record study appointments, pen, and tote bag; 
the total value of these items is less than $25. When families complete the intervention, 
they will also receive a token to celebrate their graduation from the program which will 
be valued at less than $15 (e.g., a t-shirt for their child with the lab name, a stuffed 
animal for their child with the lab name on it). s 
 
14.0 WITHDRAWAL 
OF SUBJECTS 
14.1 Describe the anticipated circumstances under which subjects will be 
withdrawn by the study team from the research without their consent. 
Not Applicable 
14.2 Describe any procedures for orderly termination. 
Not Applicable 
14.3 Describe procedures that will be followed when subjects withdraw from 
the research, including partial withdrawal from procedures with continued 
data collection, withdrawal of previously collected data upon request, etc. 
Consent may be withdrawn by the participant at any time during the study. Participants 
will be made aware of this right during the consent process.  
 
15.0 RISKS TO 
SUBJECTS 
15.1 Describe the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related to the subjects’ participation in the 
research. It may be useful to include: a description of the probability, 
magnitude, duration, and reversibility of the risks. Consider the physical, 
psychological, social, legal, and economic risks. 
Potential risks to participants are expected to be relatively low. Participants will be 
informed of the efforts that will be made to keep their responses confidential, and the 
limits of confidentiality will also be reviewed. Potential risks of choking or growth 
faltering will be monitored at each study contact. Also, there is increased risk of 
COVID-19 exposure at the present time. However, telecommunication could be used 
for completion of all study visits if necessary per COVID-19 recommendations and 
protocols at the time of data collection to reduce this risk for participants (see 15.5). 
 
15.2 If applicable, indicate which procedures may have risks to the subjects 
that are currently unforeseeable.  
Not Applicable 
15.3 If applicable, indicate which procedures may have risks to an embryo or 
fetus should the subject or the subject’s partner be or become pregnant. 
Not Applicable 

 
 
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15.4 If applicable, describe risks to those who are not subjects.  
Not Applicable 
15.5 Describe the procedures and actions taken to mitigate the risks to 
subjects and others.  
Families will be notified if our independent safety monitor (ISM) identifies any greater risk 
in the treatment condition, but at this time we do not believe there is any increased risk 
from our treatment. An ISM external to the study team will be identified to assess any 
potential changes in the known risks of participating in this study. 
Our study team will also minimize participant and study staff COVID-19 exposure, 
transmission, and infection by implementing all COVID-19 related policies and 
procedures in place at the time of data collection. Telecommunication strategies may 
be used rather than in-person data collection if warranted based on COVID-19 risk and 
recommendations. Any in-person activities will only be adopted when the university 
COVID-19 research guidelines permit these activities to resume. The IRB will be notified 
via RNI at that time, if indicated by revised guidelines. 
 
16.0 POTENTIAL 
BENEFITS TO 
SUBJECTS 
16.1 Describe the potential benefits that individual subjects may experience 
from taking part in the research. It may be useful to include: the probability, 
magnitude, and duration of the potential benefits. Indicate if there is no 
direct benefit to subjects. Do not include benefits to society or to others. 
Mothers may benefit from participation in the study through receipt of a potentially 
efficacious intervention to promote healthy infant feeding and reduce subsequent 
obesity-risk. 
 
17.0 DATA 
MANAGEMENT AND 
CONFIDENTIALITY 
17.1 Describe the data analysis plan, including any statistical procedures or 
power analyses. 
Aim 1: GLA data analysis will be conducted in real-time by the participants during the 
session. Participants will reach consensus on overall themes and action items.  
Aim 2: Proportion of infants with BMI ≥85th percentile will be compared between the 
treatment and control group using a Fisher’s exact test of independence, including all 
randomized participants in an intention to treat framework. If baseline differences are 
found between groups, these baseline variables will be included in an adjusted logistic 
regression model with odds ratios of the intervention group estimated relative to the 
control group. Sensitivity analyses will examine the impact of treatment fidelity on 
intervention efficacy. Secondary outcomes of infant diet diversity and servings of 
fruits and vegetables will be evaluated using general linear models, adjusting for 
baseline characteristics as needed. Infant biological sex and participation in other 
supplemental nutrition programs (e.g., WIC) will be explored as potential moderators 
of treatment outcomes. 
17.2 Describe the steps that will be taken to secure the data. 

 
 
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Aim 1: For aim 1, participants will complete demographic information in an online 
survey. In this survey, they will also need to indicate their email address in order to 
receive their electronic gift card for participation in the group. They will also be asked 
on the form their interest in participating in subsequent action planning groups, and we 
will use their email to contact interested participants. In order to secure confidentiality 
of demographic data, we will remove the potentially identifying email address from 
the database as soon as the groups are completed.  
Aim 2: Demographic information and maternal quantitative feedback on the 
intervention will be obtained through an online survey using the data capturing system 
REDCap. Maternal qualitative feedback on the intervention will be obtained via 
interview at the post-treatment study visit, and peer counselors will also complete 
qualitative interviews with research staff to provide feedback on the intervention. All 
data will be identified with ID numbers only, and the list linking ID numbers to 
participant names will be kept in a password-protected document separate from all 
other participant data on a password protected computer and secure server. Only study 
staff will have access to participant identifiable information during the study. 
17.3 Describe any procedures that will be used for quality control of data 
collection.  
Infant anthropometric measurements will be recorded on paper-and-pencil forms, and 
dietary information will be retrieved via phone interview. All other maternal-report 
measures will be completed through a REDCap survey on a tablet. REDCap software is 
administered by the Center for Clinical and Translational Science and Training (CCTST). 
The REDCap survey and database will be built by study staff, and tested for accuracy 
until all issues have been resolved prior to moving the survey into production for data 
collection. Only study staff will have access to the REDCap database. 
Each treatment session will be audio recorded to monitor treatment fidelity. Recordings 
will be coded by study staff who are not providing the intervention for whether each of 
the treatment components outlined in the treatment module is covered at each session. 
All data will be labeled with a subject ID only and stored on password protected 
computers, on secure network drives, or in locked filing cabinets. Consent forms will be 
stored in a separate locked filing cabinet. The document linking study ID number to 
participant names will be password protected and stored in a location separate from 
other study data. Data collected on paper-and-pencil forms will be entered into the 
study database by study staff. All manually entered data will receive a second-pass 
review to ensure accurate entry. Data entry date and the person entering data will be 
documented on each paper-and-pencil form. 
Electronic data and files will be stored on a secure internal network drive with user-level 
access. This network is backed up in accordance with standard UC IT procedures. A 
secure restricted data drive will be used to share data electronically with study team 
members at CCHMC. 
17.4 Describe how data or specimens will be handled study wide as outlined 
below. 

 
 
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17.5 What information will be included in the data or associated with the 
specimens? 
Research materials will be obtained from participants at the baseline and post-
treatment study visits and via telephone interviews. This includes demographic 
information and maternal quantitative feedback on the intervention. Research staff will 
also complete infant weight and length measurements using a mobile SECA baby scale 
and infant length board. Dietary information will be obtained via telephone interviews 
with trained staff from the Schubert Research Clinic Bionutrition Core.   
17.6 Who will have access to the data or specimens? 
Only study staff will have access to participant identifiable information during the 
study. 
 
17.7 Where and how data or specimens will be stored? 
 
Electronic data will be stored on a secure internal network drive with user-level access. 
This network is backed up in accordance with standard University of Cincinnati IT 
procedures. A secure restricted data drive will be used to share data electronically with 
the study team members at CCHMC. 
17.8 How long the data or specimens will be stored? 
We will retain identifiable information for 2 years after this research ends, to permit 
longer-term follow up. After that point, all identifying data will be destroyed, and only 
deidentified study data will be retained for future analyses. 
17.9 If applicable, how data or specimens will be transported? 
Not Applicable 
17.10 Who is responsible for receipt or transmission of the data or 
specimens? 
Data will be received or transmitted through a secure network drive or connection. The 
PI will be responsible for data receipt and transmission. 
 
18.0 PROVISIONS TO 
MONITOR THE DATA 
TO ENSURE THE 
SAFETY OF 
SUBJECTS 
18.1 For more than minimal risk research, describe the plan to periodically 
evaluate the data collected regarding both harms and benefits to determine 
whether the subjects remain safe.  
Not Applicable. Although the study is considered only minimal risk research, an 
independent safety monitor (ISM) will be identified during the study start-up phase and 
whose primary purpose will be to provide guidance regarding adverse events and safety 
issues. Information regarding the data safety monitoring plan (DSMP) is presented 
below, even though the study is considered minimal risk. 
18.2 What data are reviewed, including safety data, untoward events, and 
efficacy data? 
The ISM will review relevant participant safety data and make recommendations 
regarding continuation, modification, or termination of the trial due to safety risk. 

 
 
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Communication with the ISM will occur on an as-needed basis when safety concerns 
arise as well as annual meetings with the study PI to discuss overall trial safety data. 
18.3 How will the safety information will be collected? 
Adverse event data collection sheets have been established for recording adverse 
events reported by participants. These forms will be completed at each treatment 
session (i.e., Session 1, Session 2, Session 4, Session 5, and Post-Treatment) or study 
visit conducted by a research staff interventionist (i.e., not done at peer counselor-led 
sessions). For choking episodes, the date of the episode, details of the episode (e.g., 
food being eaten, situation in which eating occurred), and any intervention required (e.g., 
medical attention) will be recorded. For growth faltering, caregivers will be asked to 
describe their concerns regarding their child’s growth. Additionally, infant weight will be 
recorded at each study visit and treatment session (i.e., Session 1, Session 2, Session 4, 
Session 5, and Post-Treatment) conducted by a research staff interventionist (i.e., not 
done at peer counselor-led sessions).  All other potential adverse events reported to 
study staff will also be documented. 
18.4 The frequency or periodicity of review of cumulative data.  
Regularly scheduled meetings between the ISM and PI will occur annually. Emergency 
meetings will be scheduled by the PI if immediate concerns arise between regularly 
scheduled meetings. 
18.5 Who will review the data? 
An independent safety monitor (ISM) will be identified during the start-up phase of the 
study timeline and will provide guidance regarding adverse events and safety issues. 
18.6 The statistical tests for analyzing the safety data to determine whether 
harm is occurring.  
ANOVAs will examine the number of adverse events in the control versus intervention 
group. 
18.7 Any conditions that trigger an immediate suspension of research. 
Study participants will be informed of any changes to the known risks and benefits of 
participating in the current study, including if it is identified that treatment participants 
are at greater risk for adverse events. If participants in the treatment arm experience 
greater adverse events, possible discontinuation of the study or modification of the 
intervention will be considered under the guidance of the ISM. Any action resulting in 
temporary or permanent suspension of the study will be immediately reported to the 
funding agency program official. 
 

 
 
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19.0 PARTICIPANT 
PRIVACY 
19.1 Describe the provisions to protect participants’ privacy and to minimize 
the intrusiveness of the study questions or procedures.  
Participant responses will be linked to their study ID # rather than their names. Only 
study staff will have access to the file linking study ID# and names. All identifying 
information as defined by the HIPAA Privacy rule will be removed (e.g., birthdates) 2 
years after the research ends.  
Study staff will also receive training on information related to confidentiality and 
session content management. This training includes education about treatment content 
(e.g., responsive feeding, infant obesity risk factors) and specific treatment 
recommendations, strategies for active listening, skills for asking sensitive questions, 
and how to manage sensitive/confidential information. 
 
20.0 
COMPENSATION 
FOR RESEARCH 
RELATED INJURY 
20.1 For more than minimal risk research, describe the available 
compensation in the event of research-related injury. 
Not applicable. 
20.2 Provide a copy of contract language relevant to compensation for 
research-related injury. 
Not Applicable 
 
21.0 ECONOMIC 
BURDEN TO 
SUBJECTS 
21.1 Describe any costs that subjects may be responsible for because of 
participation in the research.  
There are no anticipated costs that participants may be responsible for. 
 

 
 
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22.0 CONSENT  
22.1 Obtaining consent – Check applicable and complete the corresponding 
section(s). Please note, sections 23-28 each apply under different 
circumstances. Please complete the correct sections as checked in this 
section (e.g. if you do not request a waiver of documentation of consent, do 
not complete section 24) 
☒ 
The research team will obtain written consent from all subjects. 
(Complete section 23) (HRP-502M TEMPLATE Medical Informed Consent 
or HRP-502S TEMPLATE SBER Informed Consent or HRP-502V TEMPLATE 
VA Informed Consent) 
☒ 
The research team will obtain consent from all subjects but is 
requesting a waiver of documentation (signature) of consent. (Complete 
sections 23 and 24) (HRP-502I TEMPLATE Information Sheet) 
☐ 
The research team is requesting a waiver or alteration of the consent 
process. (Complete section 25) 
☐ 
The research team is requesting Exception from Informed Consent for 
emergency research. (Please complete the EFIC supplement document 
and upload under number 3 on the local site documents page in RAP) 
☐ 
The research team will enroll Non-English-speaking subjects and obtain 
consent (written or otherwise). (Complete sections 23 and 26) 
☒ 
The research team will enroll subjects who are not yet adults (infants, 
children, teenagers) and will obtain written consent from the subject’s 
parent(s) or guardian(s). (Complete sections 22 and 27) (Parent 
Permission Template) 
☐ 
The research team will enroll adult subjects unable to provide consent 
(cognitively impaired individuals) and will obtain written consent from 
the subject’s Legally Authorized Representative. (Complete sections 23 
and 28) 
 

 
 
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23.0 CONSENT 
PROCESS 
23.1 Where will the consent process take place? 
For Aim 1, participants will review an information sheet containing all elements of 
consent before the first GLA visit. They will indicate their consent to participate by 
logging on electronically to participate in the visit. For Aim 2, the consent process will 
occur at the participant's baseline visit, prior to completion of any study procedures. 
23.2 Is there a waiting period available between informing the prospective 
subject and obtaining the consent? 
For Aim 1, participants will have time to read the information sheet and decide whether 
to participate or not before the GLA visit.  For Aim 2, interested mothers will be 
contacted by the study staff via phone. Mothers will be provided information about the 
study procedures and inclusion criteria will be assessed. If inclusion criteria are met and 
a mother is interested in participating, a baseline study visit will be scheduled when the 
child is around 2 months of age. At this visit, informed consent will be obtained. 
23.3 Describe: 
• The role of the individuals listed in the application as being involved in 
the consent process.  
• The time that will be devoted to the consent discussion. 
• Steps that will be taken to ensure the subjects’ understanding.  
• Steps that will be taken to minimize the possibility of coercion or 
undue influence.  

 
 
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Consent will only be obtained by trained study staff listed in the application as being 
involved in the consent process. Participants will be informed of the voluntary nature 
of their participation and the fact that refusal to participate does not in any way result 
in the reduction or denial of other home visiting services. They will be informed that 
the purpose of the study is to evaluate the effectiveness of an intervention targeting 
healthy infant feeding, and they will be informed regarding study procedures. They 
will also be told that HEMI visits will be digitally recorded for fidelity purposes. 
Participants will be informed that even if they agree to participate, they may withdraw 
their consent at any time without affecting the other services that they receive from 
ECS. Informed consent will be completed prior to the start of any study procedures. 
They will be given a copy of the consent form. Because of the possibility that some 
mothers will have limited literacy skills, we will read the procedures section to all 
mothers. Moreover, we will verbally reiterate that participation is voluntary, they can 
leave at any time, and that home visiting services will not be affected by their 
decision. A consent checklist has been developed to ensure that all components of 
consent are addressed.  
For Aim 2, consent will be completed electronically via REDCap. The IRB approved 
consent will be modified to an electronic format in REDCap that includes all the same 
elements found on the paper document (i.e. IRB number, approval dates, and UC logo, 
etc.). The elements of the consent requiring a signature will be added as a generate 
field. The instrument includes fields to capture full name, signature, and date and time 
of the signature for the consenter, and witness and conditional text that states that all 
signatures are associated with the Subject ID# registered in the database. When 
completed REDCap will generate a footer that contains the long date and time the 
document was submitted and “Confidential” listed in the header as an added 
precaution to preserve the research participants confidentiality. Subjects will elect 
either a printed or electronic copy of the e-consent document.   
If electronic consent cannot be completed via REDCap due to lack of accessibility to 
internet access, or due to comfort level with using technology, a paper copy of consent 
will be completed. Signed copies of the consent will be printed and kept secure with 
all printed files for this research study.  
After completion of consent, they will then be randomized into the treatment or 
control condition. The consent process will take less than 30 minutes. 

 
 
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23.4 Describe how consent of the subject will be documented in writing.  
A written information sheet has been established for Aim 1. For Aim 1, documentation 
will be not be required since all study procedures are occurring virtually and the consent 
form would be the only document linking participant names to the study. For Aim 2, 
consent will be documented through the completed fields in the REDCap e-consent 
form.  Documentation of consent is then stored within the REDCap online capture 
system and will be downloaded to our secure UC lab drive.  
23.5 Describe the conditions under which you believe it would be 
appropriate to obtain ongoing consent from the subjects.  
Ongoing consent will be obtained if significant study changes require participants to 
complete new study procedures or other unforeseeable study changes occur that may 
warrant ongoing consent. 
 

 
 
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24.0 WAIVER OF 
DOCUMENTATION 
OF CONSENT 
24.1 Justification for waiver of consent documentation. Check all that apply 
and provide rationale for all checked items. Please note that certain 
combinations of the selections below may justify a waiver of documentation. 
Please refer to HRP-411 – MEMBER CHECKLIST Waiver of IC Documentation 
to determine if your study qualifies for a waiver of documentation, and which 
boxes to check to justify the waiver. 
☐ 
N/A not requesting a waiver of documentation of consent.  
☒ 
The research presents no more than minimal risk to subjects. The GLA 
phase (Aim 1) of the current study is considered minimal risk. These meetings will 
not be audio- or video-recorded and contact information will only be collected and 
used for those individuals expressing interest in participating in more than one 
GLA. Following the last meeting, all identifiable information linking GLA members 
to the study will be destroyed. 
☒ 
Written information describing the research is to be provided to the 
subject, subject parent(s) or guardian(s), or subject Legally Authorized 
Representative. Written information describing the research will be provided to 
each participant via the Information Sheet. Research participants are encouraged 
to print this form, review it, and it for their records. 
☐ 
Written information describing the research does not need to be 
provided to the subject, subject parent(s) or guardian(s), or subject 
Legally Authorized Representative. Not Applicable 
☒ 
The research involves no procedures for which written consent is 
normally required outside of the research context. The research is limited 
to procedures for which written consent would not normally be required outside of 
the research context (i.e., online virtual meetings or phone calls). 
☒ 
The only record linking the subject and the research would be the 
consent documentation. This part of the study (Aim 1) uses an online virtual 
meeting or phone call methodology and is not associated with more than minimal 
risk to participants. If signed consent were obtained, this would be the only 
identifying information linking the participant to their survey responses. 
☒ 
The principal risk of a signed consent document would be the potential 
harm resulting from a breach of confidentiality. The rationale for changing 
the consenting procedure for Aim 1 (GLA) is that we have no credible need to 
collect and maintain the identities of our research participants beyond their 
participation in the planning meetings for the study. In doing so, we would 
introduce the unnecessary risk that an individual's identity could be connected to 
their data and input, and thus by collecting and maintaining signed consent forms, 
we introduce the potential risk of a breach of confidentiality that would not 
otherwise exist. 
☐ 
The subjects are members of a distinct cultural group or community in 
which signing forms is not the norm. Not Applicable 

 
 
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☒ 
There is an appropriate alternative mechanism for documenting that 
informed consent was obtained. Participants will be presented with an 
Information Sheet, but it will not require the participant to sign the form. Instead, 
participants will agree to participate by continuing with study procedures (i.e., 
online virtual meeting or phone call) after receiving the Information Sheet. If they 
decline to participate, they will not be asked to continue on with the GLA meetings. 
☒ 
The research is not FDA-Regulated.  
☒ 
The written script of the information to be provided orally, 
electronically, or on paper (information sheet) includes all required and 
appropriate additional elements of consent disclosure. When 
requesting a waiver of documentation, an information sheet is required. 
This box should always be checked for a waiver of documentation. 
(Follow HRP-502I TEMPLATE Information Sheet) Participants will be sent the 
Information Sheet that is identical to a conventional informed consent form and 
contains all necessary information. 
☐ 
Other DescribeNot applicable 
 
25.0 WAIVER OR 
ALTERATION OF 
CONSENT PROCESS 
25.1 Justification for waiver or alteration of the consent process. Check all 
that apply and provide a rationale/explanation for all checked statements. 
Please note that certain combinations of the selections below may justify a 
waiver of or alteration of consent. Refer to HRP-410 – MEMBER CHECKLIST 
Waiver of IC Process to determine if your study qualifies for a waiver or 
alteration of consent, and which boxes to check to justify the waiver or 
alteration. 
☒ 
N/A Not requesting a waiver or alteration of consent process.  
☐ 
The research does NOT involve non-viable neonates. 
Rationale/Explanation 
☐ 
The research involves no more than Minimal Risk to subjects. 
Rationale/Explanation 
☐ 
The research could NOT practicably be carried out without the waiver or 
alteration. Rationale/Explanation 
☐ 
The waiver or alteration will NOT adversely affect the rights and welfare 
of the subjects. Rationale/Explanation 
☐ 
Whenever appropriate, the subjects will be provided with additional 
pertinent information after participation. Rationale/Explanation 
☐ 
The research is NOT FDA regulated. Rationale/Explanation 
☐ 
Other Describe any other reasons/explanations for request of 
waiver/alteration 
 

 
 
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26.0 CONSENT OF 
NON-ENGLISH-
SPEAKING 
SUBJECTS 
26.1 Indicate what language(s) other than English are understood by 
prospective subjects or representatives. (Please note that if non-English 
speaking subjects will be consented, translated consent forms must be 
uploaded into the consent section of the RAP Smart Form.  For Greater than 
minimal risk studies, a third-party translation certificate is also required. For 
minimal risk studies, the consent must be translated by someone 
independent of the study team and their credentials should be provided.) 
Participants will be enrolled who are English or Spanish speaking, and therefore consent 
will be done in English and Spanish. A letter has been uploaded with the credentials of 
the translators who translated the Information Sheet and Consent Form into Spanish, 
and the Spanish version of these documents has been uploaded.  
26.2 If subjects who do not speak English will be enrolled, describe the 
process to ensure that the oral and written information provided to those 
subjects will be in that language. Indicate that language that will be used by 
those obtaining consent.  
Spanish speaking families will be enrolled. They will complete consent using a consent 
document in Spanish and consent will be completed with a Spanish speaking 
researcher. All elements of the consent process will be completed in Spanish.  
 

 
 
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27.0 CONSENT OF 
SUBJECTS WHO ARE 
NOT YET ADULTS 
(infants, children, 
adolescents) 
27.1 Describe the criteria that will be used to determine whether a 
prospective subject has not attained the legal age for consent to treatments 
or procedures involved in the research under the applicable law of the 
jurisdiction in which the research will be conducted (e.g. individuals under 
the age of 18 years (Ohio)) 
Participants recruited for Aim 2 (only) are infants whose mothers will be consented only 
if they are at least 18 years of age. We will also include this in the discussion and 
verification of inclusion criteria in the written informed consent document. Aim 1 
participants are all adults over 18 years of age. 
27.2 Describe whether parental permission will be obtained. (Parent 
Permission Template) 
Parent permission will be obtained from: 
• One parent even if the other parent is alive, known, competent, 
reasonably available, and shares legal responsibility for the care and 
custody of the child. 
27.3 Describe whether permission will be obtained from individuals other 
than parents, and if so, who will be allowed to provide permission. Describe 
the process used to determine these individuals’ authority to consent to 
each child’s general medical care. 
The ECS program from which participants are recruited only enrolls legal guardians and 
their children, and therefore it is known that all mothers are the legal guardian. 
27.4 Indicate whether assent will be obtained from all, some, or none of the 
children. If assent will be obtained from some children, indicate which 
children will be required to assent. (HRP-502Y Youth Assent or Medical 
Assent Template) 
Assent will not be required as children enrolled in this study are infants. 
27.5 When assent is obtained, describe whether, and how, it will be 
documented.  
Not Applicable 
 

 
 
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28.0 
CONSENT/ASSENT 
OF COGNITIVELY 
IMPAIRED ADULTS 
28.1 For potentially cognitively impaired adults, describe the process to 
determine whether an individual is capable of consent. 
Not Applicable 
28.2 List the individuals from whom permission will be obtained in order of 
priority. (Please note that the consent form will require revision to add a 
signature line for LAR and authority of LAR). 
Not Applicable 
28.3 Describe the process for assent of the subjects. Indicate whether 
assent will be required for all, some, or none of the subjects. If some, 
indicate which subjects will be required to assent and which will not.  
Not Applicable 
28.4 If assent will not be obtained from some or all subjects, explain why. 
Not Applicable 
28.5 Describe whether assent of the subjects will be documented and the 
process to document assent. 
Not Applicable 
 
29.0 HIPAA 
29.1 If you will use hospital or other healthcare provider records, data from a 
research data repository or any other information maintained by a hospital, 
academic medical center, or another healthcare entity, how will you gain 
access to the information? (check all that apply, i.e. if you will request a 
waiver for screening and obtain a signed authorization upon enrollment, 
check both). 
☒ 
Not using HIPAA-protected information for any research activities 
☐ 
Through a HIPAA Authorization signed by the participant (or their legally 
authorized representative).  
☐ 
Requesting that the IRB approve a waiver of authorization in this 
application. Submit HRP-209 – FORM – UC Waiver of HIPAA 
Authorization 
☐ 
As a limited data set under a data use agreement. 
 
30.0 STUDY 
INTERVENTION/ 
INVESTIGATIONAL 
AGENT 
30.1 FDA – Select all that apply. 
☐ Drugs/Biologics 
The proposed research involves the administration of an 
article (e.g. drug, biologic, herbal preparation, dietary 
supplement, etc.) to a human where the article is 
intended for use in the diagnosis, cure, mitigation, 
treatment, or prevention of disease or is intended to affect 
the structure or any function of the body. For both FDA 
and non-FDA approved article. Include HRP-306 – 

 
 
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WORKSHEET Drugs and Biologics in the submission in 
RAP. 
☐ Devices 
Any research that involves the use of a device (medical or 
other devices, approved or investigational) to test the 
safety or effectiveness of the device or the device is the 
focus of the research. Note: This includes research that 
will use human samples to test the safety or effectiveness 
of a device. Include HRP-307 – WORKSHEET Devices in the 
submission in RAP. 
☐ Data Collection 
Any research that involves the collection of data or other 
results from individuals that will be submitted to, OR held 
for inspection by, the FDA. In general, this would include 
research that involves any data that will be provided (in 
any form) to a pharmaceutical, medical device or biotech 
company. 
☐ 
Specimens 
Any research activity where specimens (of any type) from 
individuals, regardless of whether the specimens are 
identifiable, are used to test the safety or effectiveness of 
any device (medical or other devices, approved or 
investigational) and the information will be submitted to, 
or held for inspection by, the FDA. 
☒ Not Applicable 
None of the above describes my research.  
30.2 Describe the study intervention and/or investigational agent (e.g. drug, 
device) that is being evaluated.  
Not Applicable 
30.3 Drug/Device Handling: Describe plans to store, handle, and administer 
those drugs or devices so that they will be used only on subjects and be used 
only by authorized investigators. 
Not Applicable 
30.4 If the drug is investigational and has an IND or if the device has an IDE, 
or claim of an abbreviated IDE (non-significant risk device) include the 
information below: 
• Identify the holder of the IND/IDE/Abbreviated IDE 
• Explain the procedures followed to comply with the sponsor 
requirements for FDA regulated research (as applicable, 21 CFR 11, 21 
CFR 54, 21 CFR 210, 21 CFR 211, 21 CFR 312, 21 CFR 812, 21 CFR 820) 
• If the PI holds the IND/IDE, please include the FDA Application and the 
FDA Letter of Acknowledgement on the Drugs/Devices page of the RAP 
Smart Form. Please also note that a Safety Monitoring Plan will be 
required if the PI holds the IND/IDE. 
Not Applicable 
 

 
 
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31.0 ADDITIONAL 
REVIEWS AND 
CONSIDERATIONS 
31.1 Check all that apply.  
☐ 
The proposed research meets the definition of a clinical trial, is 
regulated by HHS, and requires that the consent form is posted to a 
federal website within 60 days of completion 
Clinical Trial: A research study in which one or more human participants 
are prospectively assigned to one or more interventions (which may 
include placebo or control) to evaluate the effects of those 
interventions on health-related or behavioral outcomes.  
☐ 
The proposed research involves embryonic stem cells or 
xenotransplantation. 
☒ 
The PI is responsible for registration of this study on 
www.clinicaltrials.gov. (Please contact the Human Research Protection 
Program with questions about clinicaltrials.gov) 
☐ 
The proposed research requires review by the Institutional Biosafety 
Committee (IBC). IBC review is required for research that will utilize 
infectious agents, select agents, recombinant DNA or viral gene 
transfer vectors, toxins for human gene transfer or genetically modified 
agent. 
☐ 
The proposed research requires Radiation Safety Committee (RSC) 
review. RSC review is required if the research involves participants 
being exposed to radiation for research purposes or an increase in 
frequency or duration of radiological imaging procedures.  
☐ 
UC Student is serving as Principal Investigator (Add the Faculty Advisor 
to the Study Team Members page in the RAP Smart Form and ensure 
that their CV is included in their RAP profile.) 
☐ 
UC study team members will be conducting research activities at 
international location(s).  
If the research involves international locations, describe additional 
safeguards included to protect the rights and welfare of subjects 
recruited in these locations. Refer to HRP-399 – MEMBER WORKSHEET 
International Research for more information on the information 
required for review for international studies. 
Description, e.g. information about local research oversight, local context, 
etc. 
☐ 
Collection of information that may include incriminating activities (e.g. 
illicit drug use, illicit sexual behaviors, fraudulent behaviors, theft, 
abortion or other related activities that may be illegal in some states, 
assault) 

 
 
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☐ 
Review of UC Student records without obtaining consent. If so, a FERPA 
waiver is required. (Please reach out to Lorre Ratley with UC Office of 
General Counsel.) 
☐ 
Sharing of genomic information generated from NIH-funded research 
☐ 
 
UC Health services will be utilized (check applicable). 
☐ 
Investigational Drug 
Services 
☐ 
Imaging 
Services 
☐ 
Lab Services 
☒ 
CCHMC Services will be utilized (check applicable). 
☐ 
CICRL 
☐ 
IRC 
☒ SRC 
☐ 
Acute Care Research (Research that occurs within 24 hours of a visit to 
an emergency department or unscheduled admission, or within 24 
hours of identification of a new or worsening condition – characterized 
by sudden onset requiring immediate care) 
☐ 
The research team will send data FROM the United States TO another 
country: if so, list the country or countries here 
☐ 
The research team will send data FROM another country TO the United 
States: if so, list the country or countries here 
 
32.0 REGULATORY 
OVERSIGHT 
32.1 Check the applicable federal oversite and/or funding.  
☐ 
Environmental Protections Agency 
☐ 
Department of Energy 
☐ 
Tribal Law 
☐ 
Department of Defense 
☐ 
Department of Justice 
☐ 
Department of Education 
☐ 
Food and Drug Administration 
☒ 
Health and Human Services 
(NIH) 
☐ 
Office of Civil Rights 
☐ 
National Science Foundation 
☐ 
Veterans Affairs *See Below 
☐ 
Other Federal Agency  
☐ 
*Check if you will enroll non-
veterans 
☐ 
ICH-GCP (E6)  
☐ 
Specify other federal agency/oversight 
Name 
 
33.0 SETTING 
33.1 Where will research activities take place, including where data will be 
stored/accessed (check all that apply). 
☐ 
Barrett Cancer Center 
☐ 
Infectious Disease Clinic 
(Holmes-UC Health) 
☐ 
Blue Ash Campus 
☐ 
Kettering Laboratory 

 
 
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☐ 
Cincinnati State Technical and 
Community College 
☐ 
Linder Center of Hope 
☐ 
Clermont College 
☐ 
Liver Transplant Clinic 
(Medical Arts Building) 
☐ 
College of Allied Health Sciences 
☐ 
Medical Sciences Building 
☒ 
College of Arts & Sciences 
☐ 
Shriners Hospital 
☐ 
College of Business 
☐ 
Talbert House 
☐ 
College Conservatory of Music 
☐ 
UC Gardner Neuroscience 
Institute 
☐ 
College of Design, Art, Architecture 
& Planning 
☐ 
UCMC (Emergency 
Department, Inpatient and 
Outpatient Units) 
☐ 
College of Education 
☐ 
UCMC NICU 
☐ 
College of Nursing 
☐ 
University of Cincinnati 
Physicians (UCP) 
☐ 
College of Pharmacy 
☐ 
University Pointe Surgical 
Hospital 
☐ 
Crossroads Center 
☐ 
VA – Cincinnati Medical 
Center 
☐ 
Drake Center 
☐ 
VA – Chillicothe Medical 
Center  
☐ 
Genome Research Institute 
(Reading Campus) 
☐ 
VA – Columbus Medical 
Center 
☐ 
Hoxworth: Inpatient Unit 
☐ 
West Chester Hospital 
☐ 
Hoxworth: Outpatient Clinics 
☐ 
Other UC/UC Health 
Affiliated location/clinic: list 
location/clinic 
 
34.0 EXTERNAL 
LOCATIONS 
34.1 List any external locations to UC or its affiliates. 
External institutions with collaborators: Cincinnati Children's Hospital Medical Center, 
Every Child Succeeds. CCHMC IRB will also be conducting their own review of this 
study.   
 

 
 
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35.1 List any references sited throughout the protocol below. 

 
 
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35.0 REFERENCE 
LIST 
1. Watts AW, Mason SM, Loth K, Larson N, Neumark-Sztainer D. Socioeconomic 
differences in overweight and weight-related behaviors across adolescence and young 
adulthood: 10-year longitudinal findings from project EAT. Prev Med. 2016;87:194-
199.  
2. Lieb DC, Snow RE, DeBoer MD. Socioeconomic factors in the development of 
childhood obesity and diabetes. Clin Sports Med. 2009;28(3):349-378.  
3. Wang Y, Lim H. The global childhood obesity epidemic and the association 
between socio-economic status and childhood obesity. Int Rev Psychiatry. 
2012;24(3):176-188.  
4. Paul IM, Savage JS, Anzman SL, et al. Preventing obesity during infancy: A pilot 
study. Obesity (Silver Spring). 2011;19(2):353-361.  
5. Fagg J, Cole TJ, Cummins S, et al. After the RCT: Who comes to a family-based 
intervention for childhood overweight or obesity when it is implemented at scale in the 
community? J Epidemiol Community Health. 2015;69(2):142-148.  
6. Cloutier MM, Wiley JF, Kuo CL, Cornelius T, Wang Z, Gorin AA. Outcomes of an 
early childhood obesity prevention program in a low-income community: A pilot, 
randomized trial. Pediatr Obes. 2018;13(11):677-685.  
7. Reifsnider E, McCormick DP, Cullen KW, et al. Randomized controlled trial to 
prevent infant overweight in a high-risk population. Acad Pediatr. 2018;18(3):324-
333.  
8. Davison KK, Birch LL. Childhood overweight: A contextual model and 
recommendations for future research. Obes Rev. 2001;2(3):159-171.  
9. Hammond RA. Complex systems modeling for obesity research. Prev Chronic Dis. 
2009;6(3) 
10. Mason SM, Bryn Austin S, Bakalar JL, et al. Child maltreatment's heavy toll: The 
need for trauma-informed obesity prevention. Am J Prev Med. 2016;50(5):646-649. 
11. Folger AT, Putnam KT, Putnam FW, et al. Maternal interpersonal trauma and 
child social-emotional development: An intergenerational effect. Paediatr Perinat 
Epidemiol. 2017;31(2):99-107. 

 
 
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12. Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of obesity among adults 
and youth: United states, 2015-2016. NCHS Data Brief. 2017;(288)(288):1-8.  
13. Ogden CL, Carroll MD, Fakhouri TH, et al. Prevalence of obesity among youths 
by household income and education level of head of household - united states 2011-
2014. MMWR Morb Mortal Wkly Rep. 2018;67(6):186-189.  
14. Ogden CL, Fryar CD, Hales CM, Carroll MD, Aoki Y, Freedman DS. Differences 
in obesity prevalence by demographics and urbanization in US children and 
adolescents, 2013-2016. JAMA. 2018;319(23):2410-2418.  
15. Smego A, Woo JG, Klein J, et al. High body mass index in infancy may predict 
severe obesity in early childhood. J Pediatr. 2017;183:87-93.e1.  
16. Eriksson J, Forsen T, Osmond C, Barker D. Obesity from cradle to grave. Int J 
Obes Relat Metab Disord. 2003;27(6):722-727.  
17. Woo Baidal JA, Locks LM, Cheng ER, Blake-Lamb TL, Perkins ME, Taveras 
EM. Risk factors for childhood obesity in the first 1,000 days: A systematic review. 
Am J Prev Med. 2016;50(6):761-779.  
 18. Aris IM, Bernard JY, Chen LW, et al. Modifiable risk factors in the first 1000 
days for subsequent risk of childhood overweight in an asian cohort: Significance of 
parental overweight status. Int J Obes (Lond). 2018;42(1):44-51.  
19. Dattilo AM. Modifiable risk factors and interventions for childhood obesity 
prevention within the first 1,000 days. Nestle Nutr Inst Workshop Ser. 2017;87:183-
196.  
20. Pietrobelli A, Agosti M, MeNu Group. Nutrition in the first 1000 days: Ten 
practices to minimize obesity emerging from published science. Int J Environ Res 
Public Health. 2017;14:1491.  
21. Fein SB, Labiner-Wolfe J, Scanlon KS, Grummer-Strawn LM. Selected 
complementary feeding practices and their association with maternal education. 
Pediatrics. 2008;122 Suppl 2:91.  
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