Incorporating Cardiovascular Risk Assessment Into Adolescent and Young Adult Visits to Improve Cardiovascular Health
Phase: NA
Conditions: Cardiovascular Diseases
Sponsor: Emory University

Incorporating Cardiovascular Risk Assessment into 
Adolescent & Young Adult 
Visits to Improve Cardiovascular Health 
 (Short title: Incorporating CV Risk Assessment in AYA 
Visits) 
 
NCT Number: NCT05384834 
 
Protocol Version 7.0.1 Date: October 28, 2022 
 

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Protocol Version: 7.0.1 10/28/2022
IRB Form SOCIOB 08102020
PROTOCOL TITLE: Incorporating Cardiovascular Risk Assessment into Adolescent & Young Adult 
Visits to Improve Cardiovascular Health
PRINCIPAL INVESTIGATOR:
Department of Pediatrics
CO-INVESTIGATORS:
Department of Gynecology and Obstetrics
Department of Pediatrics
RESEARCH COORDINATOR:                                                                 
Department of Pediatrics
VERSION: 7.0.1
FUNDING SOURCE: This study is funded by the NIH National, Heart, Lung and Blood Institute.

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REVISION HISTORY
Revision #
Version 
Date
Summary of Changes
1
10/01/2020
Removed clinical trial portion of study
2
10/12/2020
Removed external collaborator not engaged in research
3
05/07/2021
Removed several survey questions and added study flyer
4
06/24/2021
Removed more survey questions; modified interview guide
5
8/13/2021
Added pre-screening phone calls to protocol
6
9/18/2021
Clarified which health care providers are eligible, updated 
health care provider recruitment email. Requested waiver 
of parental permission under certain circumstances. 
Updated consent procedures.
7
4/4/2022
Updated protocol to reflect recruitment changes in Aim 2
8
5/10/2022
Updated protocol to include Aim 3
9
10/28/2022
Increased enrollment size to 60 participants
Table of Contents
1.
Study Summary .......................................................................................................................4
2.
Objectives................................................................................................................................4
3.
Background .............................................................................................................................4
4.
Study Endpoints ......................................................................................................................4
5.
Study Intervention / Design ....................................................................................................4
6.
Procedures Involved................................................................................................................5
7.
Data and Specimen Banking....................................................................................................5
8.
Sharing of Results with Participants........................................................................................5
9.
Study Timelines .......................................................................................................................6
10.
Subject Population...............................................................................................................6
11.
Vulnerable Populations .......................................................................................................6
12.
Local Number of Participants ..............................................................................................6
13.
Recruitment Methods..........................................................................................................7
14.
Withdrawal of Participants..................................................................................................7
15.
Risks to Participants.............................................................................................................7
16.
Potential Benefits to Participants........................................................................................7
17.
Data Analysis, Management and Confidentiality.................................................................8
18.
Provisions to Monitor the Data to Ensure the Safety of Participants..................................8

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19.
Provisions to Protect the Privacy Interests of Participants and Confidentiality of 
Participants’ identifiable data.........................................................................................................9
20.
Economic Burden to Participants ........................................................................................9
21.
Consent Process...................................................................................................................9
22.
Setting................................................................................................................................12
23.
Resources Available...........................................................................................................12
24.
Multi-Site Research when Emory is the Lead Site .............................................................12
25.
References.........................................................................................................................13

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1. Study Summary
Study Title
Incorporating Cardiovascular Risk Assessment into 
Adolescent & Young Adult Visits to Improve 
Cardiovascular Health
Study Design
Survey/Questionnaire and Behavioral Intervention
Primary Objective
Adapt a cardiovascular disease risk assessment tool 
for use in adolescent and young adult clinical practices 
in Atlanta
Secondary Objective(s)
1. Use qualitative methods to elicit information 
about what adaptations are needed to make a 
cardiovascular disease risk assessment tool and a 
companion behavioral intervention appropriate 
with adolescents/young adults
2. Adapt a cardiovascular disease risk assessment 
tool and companion behavioral intervention into a 
single integrated application for use in 
primary/reproductive care settings serving 
adolescent/young adult women
3. Pilot the new cardiovascular disease risk 
assessment tool in primary/reproductive care 
settings serving adolescent/young adult women
Research 
Intervention(s)/Interactions
Mobile app (#HerHeart) development; 
survey/questionnaire; audio-recorded interviews 
Study Population
Adolescent and young adult women presenting for 
care at the CHOA Hughes Spalding Adolescent 
Medicine clinic and the Grady Health System Teen 
Program
Sample Size
60 adolescent/young adult women
10 health care providers
Study Duration for 
individual participants
Phase 1: one hour
Phase 2: six months
Phase 3: three months
Study Specific 
Abbreviations/ Definitions 
AYA – adolescent and young adult
CHOA – Children’s Healthcare of Atlanta
CVH – cardiovascular health
CVD – cardiovascular disease
HBM – Health Belief Model
HCP – health care providers
HHS – Healthy Heart Score

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VAS – Visual Analog Scale
Funding Source (if any)
This study is being considered for funding by the NIH 
National, Heart, Lung and Blood Institute.
2. Objectives
The purpose of this study is adapt a Healthy Heart Score tool for use in adolescent and 
young adult (AYA) clinical practices in Atlanta. Our central hypothesis is that a 
developmentally appropriate lifestyle-based risk prediction tool, delivered during 
wellness, mental health, and reproductive health visits and reinforced through 
personalized goal setting, will be acceptable to young women and their providers and 
feasible to integrate into practice. The aims of the present study are as follows:
Aim 1. Using qualitative methods, elicit information about what adaptations are needed to 
make the Healthy Heart Score risk assessment tool and a companion behavioral intervention 
appropriate for use with AYAs and HCPs. We will survey and interview 20 AYA women and 10 
HCP in primary care wellness, mental health, and reproductive health practice settings. 
Aim 2. Adapt the Healthy Heart Score risk assessment tool and a companion behavioral 
intervention into a single integrated application for use in primary/reproductive care settings 
serving AYA women. We will recruit 10 additional AYA to iteratively test the new application 
using user-centered design principles. 
Aim 3. Evaluate the usability and initial feasibility of #HerHeart. We will recruit 60 additional 
AYA participants and the same 10 HCPs from Aim 1 to evaluate the usability and feasibility of 
the web tool.  
3. Background
Cardiovascular disease (CVD) remains the number one killer of women in the US despite 
decades of progress in risk factor detection and treatment.1 Awareness of CVD risk and risk 
factor control remain critical barriers to reversing this trend. In our study of young adults 
participating in the National Health and Nutrition Examination Survey 2011-2014, a substantial 
proportion of participants with hypercholesterolemia (43.1%), hypertension (37.3%) and 
diabetes (30%) at the time of their study exam reported no awareness of these diagnoses, and 
>75% of young adults with borderline levels of these risk factors were unaware of their risk.2 
This is highly concerning given the high proportion of young adults who will transition from 
borderline or intermediate cardiovascular health (CVH) to poor CVH as they reach middle age.1 
Furthermore, even intermediate CVH in adolescence and young adulthood is associated with 
subclinical markers of CVD later in life.3-6 
Low CVD awareness among AYAs is compounded by the notion that they are “young 
invincibles” with little concern for their long-term health.7 Multiple explanations are posited for 
this perceived invincibility, including ongoing development of the prefrontal cortex into the 
mid-20s 8 and age-related differences in the ability to project risk.9 As adolescents age, the 

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length of time they can project into the future increases, as does their motivation to act in the 
present when benefits may not be realized until the future.9 In our previous work, we found 
adolescents and young adults are cognitively capable of understanding short, medium, and 
long-term risk for CVD and report motivation to act now to prevent future CVD.10 
Unfortunately, in a separate study, we found 90% of young women remain unaware of the fact 
that CVD is the number one cause of death for women in the US.11 Interventions designed to 
improve CVD awareness and mitigate CVD risk with adolescents and young adults have been 
limited to unique populations, such as college students,12 or have focused on only a few CVD 
risk factors at a time, such as smoking, nutrition, physical activity, or obesity.13 Few 
interventions have targeted young women specifically, adolescents more generally, or 
addressed adolescent and young adult motivations to improve their health.  
This project will advance the state of the science regarding CVD risk communication with 
adolescent and young adult women within primary and reproductive health care systems. 
Adolescents and young adults are infrequently screened for CVD risk factors during health care 
encounters,14 and many young people do not have a routine source of primary care.15 
Grounded in the conceptual framework of the Health Belief Model (HBM),16 this feasibility 
study will incorporate CVD risk assessment into wellness, mental health, and reproductive 
health visits for adolescent and young adult women in two clinical practices that serve a 
primarily African American population with low socioeconomic status and high cardiovascular 
risk. We will address two key concepts of the Health Belief Model: a) targeting adolescent and 
young adult women’s perceived susceptibility to CVD, and b) providing a cue to action to set 
personalized goals for improving their CVH as they transition to adulthood. We hypothesize 
that a lifestyle-based risk prediction tool (the Healthy Heart Score) coupled with a companion 
behavioral intervention can be adapted for use as an integrated application for young women.
4. Study Endpoints 
Phase 1: Using qualitative methods, elicit information about necessary adaptations to 
the Healthy Heart Score risk assessment tool and a companion behavioral 
intervention. The primary endpoint of this portion of the study is the collection of 
survey and interview data from 20 AYA and 10 HCP.
Phase 2. Adapt the Healthy Heart Score (HHS) risk assessment tool and behavioral 
intervention frameworks into a single integrated application. The primary endpoint of 
this portion of the study is the creation of the single integrated application, #HerHeart.
Phase 3. Evaluate the usability and initial feasibility of #HerHeart. The primary 
endpoint of this portion of the study is the assessment of the usability of the tool and 
the feasibility of recruitment for a larger clinical trial.
5. Study Intervention / Design 

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This is a three-part study. In Aim 1/Phase 1, we will use qualitative data to understand 
necessary adaptations to two existing tools developed for adults. In Aim2/Phase 2, we 
will use user-centered design to make those adaptations in conjunction with 
participants. Aim 3/Phase 3 will test the usability of the developed tool and the 
feasibility of a larger clinical trial.
 
Procedures Involved
Phase 1: AYA participants (n=20) will complete a brief 
initial survey on a tablet to collect data listed in Table 
1. Participants will also complete the Visual Analog 
Scale (VAS) to allow them to estimate their perceived 
10-year risk of CVD, lifetime risk of CVD, and perceived 
severity of CVD. Additionally, participants will 
complete the Healthy Heart Score (HHS) beta version 
and answer questions following a semi-structured 
interview guide to elicit thoughts and comments 
about the app (AYA Data Collection.pdf). Participants 
will be queried about the optimal length of time to spend completing the tool, the 
optimal location (i.e., at the doctor’s office, online, in school), level of understanding of 
the questions and the risk prediction visualization interface, and suggested adaptations 
to the dietary and physical activity subdomains. Next, participants will provide be asked 
to suggest possible interventions to address healthy behaviors (i.e., health coach, text 
reminders, etc.). We will inquire about the optimal modality for delivering the suggested 
intervention (i.e., various social media platforms, app-based, text-based) and preferred 
frequency and timing of follow-up messages. Finally, we will elicit participant reactions 
to potential names so we can brand the single integrated application. Additionally, 10 
providers will undergo an abbreviated version of the aforementioned procedures and 
complete an interview using a provider-specific semi-structured interview guide (HCP 
Data Collection.pdf) to inquire about topics listed in Table 1. 
Data analysis from the AYA and HCP surveys will be primarily descriptive. Data will be 
summarized overall, and by location and cohort. Interviews will be recorded, 
transcribed, and inputted into Dedoose Version 7.0.23, a web application for managing, 
analyzing, and presenting qualitative and mixed method research data (SocioCultural 
Table 1. Summary of data collected in Aim 1.
Aim 1 Measures – AYA
Aim 1 Measures - HCP
i. Brief Initial Survey

Age

Race/ethnicity

Mother’s highest level of education

Zip code

VAS

AHA Women’s Health Survey
v. Provider Survey

Age

Gender

Race/ethnicity

Degree

Practice Site

Years in Practice
ii. Structured Observation Tool (time stamps)
v. Provider Semi-Structured 
Interview: HHS/DPP

Current Provision of CVD 
prevention care

Comfort with CVD risk 
assessment

Barriers/facilitators to 
providing CVD care

Perceived relevance of 
HHS/DPP

Practicality of using CVD 
application in practice
iii. Semi-Structured Interview re: HHS

Health Belief Model domains

Length of time to complete tool

Optimal location to complete tool

Understanding of questions

Suggested adaptations
iv. Semi-Structured Interview re: DPP modules

Optimal delivery modality

Preferred frequency/timing of messages

Understanding of content

Necessary adaptations

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Research Consultants, LLC, Los Angeles CA). At least two members of the research team 
will code all transcripts. Through several iterations and consensus discussions, we will 
ensure adequate thematic coding agreement (K= 70%). Identified themes will be used to 
adapt the HHS tool. 
Phase 2: We will employ an iterative user-centered design process to beta-test the 
integrated application with up to 10 additional AYA women. The additional AYA women 
will be recruited from the Emory Pipeline Collaborative (EPiC). Working with the Georgia 
CTSA Innovation Catalyst, we will engage in cycles of rapid prototyping, starting with a 
simple prototype that represents the integrated application on a storyboard and adapt 
the content based on user feedback. We will then work with the Georgia CTSA App 
Hatchery to program the web-based integrated application compatible with mobile 
devices equipped with Android or iOS operation systems. Finally, we will engage AYA 
participants in live prototyping, presenting them with a functional prototype to react to 
as they complete the assessment tool in real-time.
Throughout the design process, we will conduct observational field tests by gathering 
information about how AYA participants use the application in real-time. We will elicit 
their feedback on the usability and desirability of the integrated application throughout 
the process, and adjust the application based on their feedback. We will also examine 
automatically generated data from the application itself to identify patterns of activity 
and common problems. The end-product of Aim 2 will be the final integrated application 
consisting of a lifestyle-based CVD risk assessment and companion behavioral 
intervention. For the remainder of the protocol, we will refer to the integrated 
application as #HerHEART; however, the application will formally be named with input 
from participants in Aim 1. 
Aim 3 Measures – AYA 
Aim 3 Measures - HCP 
Primary Outcomes (3-
month Time Frame)

Changes in 
overall 
#HerHeart risk 
score 

Changes in 
overall 
composite of 
diet 

Changes in fruit 
and vegetable 
intake 

Changes in red 
and processed 
meats intake

Changes in 
sugar and 
sweetened 
beverages 

Changes in nut 
consumption

Changes in 
alcohol 
consumption

Changes in 
nicotine use

Changes in 
cereal fiber

Changes in 
physical activity
Secondary Outcomes 
(3-month Time Frame)

Changes 
in BMI

Changes 
in SBP

Changes 
in DBP
Exploratory Outcomes

WAMMI for 
#HerHeart

WAMMI for Healthy 
Heart Score

Likelihood of 
recommending 
#HerHeart to 
friends (0-10)

Likelihood of 
behavior change 
(0-10) 

VAS

Eating Disorder 
Diagnostic Scale 
(EDDS)

# of participants 
approached

# who agreed to 
participate

Completion/dropout 
rate
Exploratory Outcomes

WAMMI  for #HerHeart

Usefulness of #HerHeart to practice 
(0-10) 

Likelihood of incorporating 
#HerHeart into practice (0-10) 

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 Phase 3:  We will 
recruit 60 
additional AYA 
women and the same 10 HCPs from Aim 1 to evaluate the #HerHeart tool’s usability and 
feasibility. AYA participants will complete a brief initial survey consisting of demographic 
information and the Visual Analog Scale (VAS) and the #HerHeart tool in clinic. AYA 
participants will the rate the usability of the #HerHeart tool using the Website Analysis 
and Measurement Inventory (WAMMI), the likelihood they would recommend the app 
to their friends, and the likelihood of behavior change. AYA participants will then be 
offered the opportunity to continue into the 3-month intervention phase. We will 
document the reasons for declining as part of tracking feasibility. At the beginning of the 
intervention phase, participants will complete the Eating Disorder Diagnostic Scale 
(EDDS). Participants will then be texted 1 month and 2-months post-enrollment 
reminding them of any goals/areas of improvement indicated by their end assessment 
in the #HerHeart Tool. Three months post-enrollment, participants will attend the final 
study visit in the phlebotomy room on the second floor of CHOA Hughes Spalding. In this 
visit, AYA participants height, weight and blood pressure will be measured. Participants 
will also be asked to complete the #HerHeart tool again and the same online study 
scales collected at baseline (EDDS and VAS). They will also be asked to complete the 
Harvard Healthy Heart Score and evaluate the usability using the WAMMI. HCP 
participants will complete a survey consisting primarily of demographic information and 
the #HerHeart tool. HCP participants will then rate the usability of the tool using the 
WAMMI, the usefulness of the #HerHeart to their practice and the likelihood they would 
incorporate it into usual clinical care.
Data analysis will consist of descriptive statistics for the WAMMI and Likert scale 
surveys. Usability will be defined as >80% of AYA and HCP rating the application as 
above average on the WAMMI. Acceptability to HCP will be defined as a mean of 8 out 
of 10 Likert Scale items. Paired t-tests will be used to compare the baseline and 3-month 
data for the continuous scales (EDDS, VAS). 
Primary outcomes will include changes in overall #HerHeart risk score, composite 
dietary score, fruit and vegetable intake, red/processed meats intake, soda and 
sweetened beverages intake, nut consumption, cereal fiber consumption, alcohol 
consumption, nicotine use, and physical activity over a 3-month period. Secondary 
outcomes will include changes in BMI and systolic and diastolic blood pressure over a 3-
month period. Exploratory outcomes will include usability of the HerHeart tool and 
Healthy Heart Score as assessed by the WAMMI, adolescents’ likelihood of 
recommending the tool to friend, adolescents’ self-reported likelihood of behavior 
change, adolescents’ understanding of heart disease risk as measured by VAS, change in 
EDDS score, number of participants approached and participated, completion/dropout 
rate, HCP rated usefulness of HerHeart tool to the practice, and HCP rated likelihood of 
incorporating HerHeart tool into practice.

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All phases: The probability and magnitude of risks will be minimized by conducting 
study procedures in private settings, collecting data in REDCap, a secure web-based 
application designed exclusively to support data capture for research studies, and 
collaborating with the Georgia CTSA to ensure data security of the mobile app. 
6. Data and Specimen Banking
Data from surveys/questionnaires, audio recordings, and interviews will be stored until the 
completion of data analysis and manuscript publication. Only approved study personnel listed 
on the protocol will have access to the data. 
7. Sharing of Results with Participants
Personal Healthy Heart Score risk assessments will be shared with participants at each stage of 
the study. Participants will be encouraged to share their results with their primary care 
physicians, but results will not be directly shared with others.  
8. Study Timelines
Individuals in Aim 1/Phase 1 will participate for ~one hour, one time. Individuals in Aim 2/Phase
 2 will participate for up to two hours for each design session which will occur over 6 months. 
Aim 3/phase 3 will occur over 3 months. The total duration of the overall study is 15 months, 
which includes subject participation and data analysis.
9. Subject Population
Subjects will be recruited from the CHOA Hughes Spalding Adolescent Medicine Clinic and the 
Grady Teen Health Program. The following inclusion/exclusion criteria will be used for subject 
recruitment: 
Inclusion Criteria (AYAs):
- Patient at CHOA Hughes Spalding Adolescent Medicine Practice or the Grady Health 
System Teen Program
- Age 13-21 years
- Self-identifying as non-Hispanic Black or White race (inclusive of Hispanic ethnicity)
- Self-identifying as female 
- Visit type is annual wellness/health check, behavioral/mental health, or 
reproductive/gynecological health
- Consistent access to a mobile device with internet capability
Exclusion Criteria (AYAs):
- Cognitive impairment limiting ability to complete study procedure 
- Spoken and written language other than English 

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- Diagnosis of hypertension, diabetes, or hyperlipidemia requiring medications, or 
atherosclerotic cardiovascular disease
- Past or current diagnosis of a DSM-V eating disorder
- Diagnosis of schizophrenia, bipolar disorder, or psychiatric hospitalization in the past 12 
months
- Pregnant at the time of the study.  
Inclusion Criteria (HCPs):
- Clinical team member (physician or nurse practitioner, nurse, social worker, psychologist, 
health educator, medical assistant, dietitian) at the CHOA Hughes Spalding Adolescent 
Medicine Practice or the Grady Health System Teen Program
- Practicing at one of the study sites at least twice per month on average over the past year
Exclusion Criteria (HCPs)
      - Member of the research study team
10. Vulnerable Populations
The proposed study involves the vulnerable population of children under the legal age 
of consent to procedures involved in the research.  Though the research involves no 
more than minimal risk, we will take safeguards to protect the rights and welfare of 
these individuals. Written parental permission will be obtained for all individuals under 
the age of 18 years if the parent or legal guardian is present at the time of recruitment. 
Permission of one parent is sufficient even if the other parent is alive, known, 
competent, reasonably available, and shares legal responsibility for the care and 
custody of the child. Only parents or legal guardians listed in the child’s medical record 
will be able to provide permission. We will request a Waiver of Parental Permission as 
permitted under permitted under 45 CFR 46.408(c) for those patients under 18 years of 
age who present alone for a visit for reproductive health visits. Adolescents have the 
legal right to seek care for certain sexual health services, including contraception and 
sexually transmitted infection testing and treatment, in the state of Georgia. To contact 
the parent or guardian for consent to participate in research would violate the 
adolescents’ legal right to privacy by disclosing their presence at the clinical practice, 
even though the study does not discuss sexual health. 
Additionally, we will obtain written assent from all children to ensure they understand 
the study and agree to participate. In the event a child’s parent or guardian is not 
present, we will obtain written consent from the child using a consent form that 
provides adequate study information for the subject to make an informed decision.  For 
patients 18 years or older, we will discuss how the study will use and disclose 
individually identifiable health information and obtain written consent. Because 
participants may receive clinical care from the PI or Co-I, who are providers at the CHOA 
Adolescent Medicine practice and the Grady Teen Health Program, the consent and 

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assent process will be carried out by the research coordinator. This will aid in minimizing 
coercion or undue influence by the PI. 
11. Local Number of Participants
We will recruit 90 AYA subjects and 10 HCP subjects. Participants will be recruited from the 
CHOA Adolescent Medicine Practice and the Grady Health System Teen Program. 
12. Recruitment Methods
For aims 1 and 3, the research coordinator will preliminarily screen AYA patients from the CHOA 
Adolescent Medicine Practice and the Grady Teen Health Program using the Epic Electronic 
Medical Record system. Patients who meet preliminary eligibility criteria (race, gender, age) will 
be added to the screening log (Screening Log.xlsx) and contacted via phone by the research 
assistant to see if they are interested in participating in the study when they come in for their 
clinical visit. For aim 2, participants will be recruited from the Emory Pipeline Collaborative 
(EPiC).

Participants will be recruited both in-person and virtually, due to current COVID-19 
public health recommendations. 

Patients reached via phone will be provided a brief overview of the study and the 
research coordinator will administer the screening eligibility questionnaire (Screening 
Survey.docx). 

Those who are eligible and interested in participating will be asked if they prefer to 
attend a study visit either an hour before or an hour after their clinical visit. Participants 
will also have the option to book a separate study visit at a time not related to their 
clinical visit, to occur via Zoom. 

Patients reached via phone who are not interested in participating will be noted as such 
on the screening log.

Patients who are not reached via phone using the screening criteria but eligible for the 
study may still be approached at the time of their clinical visit.

For patients attending the clinic in person, the research coordinator will approach 
eligible AYAs in the waiting room of the clinics and lead them to a private sitting area in 
order to provide a brief overview of the study and administer the screening eligibility 
questionnaire (Screening Survey.docx). 

For patients attending the clinic via telemedicne, the physician conducting the visit will 
ask the patient if they are interested in learning about the study. If so, the research 
coordinator will schedule a date and time with the patient to provide a brief overview of 
the study and administer the screening eligibility questionnaire via a password-
protected Zoom videoconference. 
If ineligible, participants will be informed that they are not eligible to participate in the study. If 
eligible, AYA participants will then carry out the consent and study procedures for each study 
phase as described in Section 21 and 6, respectively. Interested participants will the carry out 

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the study procedures as described in Section 6. Consent and study procedures will only occur in 
the context of a study visit, and not via initial phone screening and recruitment.
To assist with recruitment efforts, a recruitment flyer containing information about the study 
(eligibility requirements, study procedures, time commitment, etc.) will be distributed in the 
CHOA Adolescent Medicine practice. The flyers will be distributed to eligible patients who may 
not have time to begin the study procedures due to normal clinic flow (i.e., patient gets called 
back to exam room before we can consent them and begin the study). 
Compensation for participants will be as follows:

Aim 1: AYA and HCP subjects will receive a $25 gift card. 

Aim 2: AYA subjects will receive a $50 gift card.

Aim 3: AYA will receive up to $60 and HCPs will receive $25
13. Withdrawal of Participants
Participants will be told that they can drop out of the study at any time during the study. 
Participants who become pregnant or become cognitively impaired throughout study 
duration will be withdrawn from the study without their consent. Furthermore, 
participants who become otherwise unable to participate in the research procedures 
due to health-related concerns will be withdrawn from the research without their 
consent at the discretion of the PI. Data collection will cease for participants who 
withdraw from the research and these individuals will not be included in the final data 
analysis.  
14. Risks to Participants
This proposed study involves no more than minimal risk. Completion of the Healthy Heart risk 
assessment tool in its current form includes the risk that AYA participants disclose heavy 
alcohol or tobacco use. Participants may find learning about their cardiovascular risk 
distressing. After learning about their cardiovascular risk, participants may make changes to 
their exercise or dietary habits outside of what is recommended in the behavioral intervention 
or would be recommended by their HCP. Participation in the interviews also carries the risk of 
AYA’s self-disclosure of health information. All efforts will be made to remind participants not 
to provide identifying information during the interviews. Breach of confidentiality is a risk for 
both AYA and HCP participants. To ensure participant confidentiality, study identification 
numbers will be assigned to each participant and used throughout the duration of the study 
when referring to subjects. The codes that link the name of the participant and the study 
identification number will be kept confidential by the PI in a secured cabinet. Only the 
authorized study team with appropriate training will have access to the data.
15. Potential Benefits to Participants

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The direct benefit to AYA participants in the survey and interviews in each aim is gaining 
information about their health. The direct benefits to HCP in Aim 1 includes learning about new 
tools or methods that can potentially be used to increase CVD awareness in patients. Overall 
this study has the potential to inform prevention practices applicable to millions of young 
women living in the United States and to possibly lower the burden of cardiovascular disease 
among women.
Though not considered a benefit, subjects will be compensated for participation in this study. In 
Aim 1, AYA and HCP subjects will receive a $25 gift card for completing surveys and interviews. 
In Aim 2, AYA participants will receive a $50 gift card for participating in the design sessions. In 
Aim 3, AYA participants will receive $25 for completing the usability assessment and up to $35 
for completing the intervention phase; HCPs will receive $25 for completing the usability 
assessment. 
16. Data Analysis, Management and Confidentiality
The main aim of the proposed study is to adapt the Healthy Heart Score tool based 
on participant feedback. As such, all data will be descriptive only.
Data from surveys/questionnaires, audio recordings, and interviews will be stored 
until the completion of data analysis and manuscript publication. Only approved study 
personnel listed on the protocol will have access to the data. To secure the study data, 
all study team members will obtain appropriate biomedical or sociobehavioral CITI 
training. Only participants’ study identification codes will be inputted into computer-
based databases. The codes that link the name of the participant and the study ID will 
be kept confidential in a secured cabinet. The self-report measures will be administered 
via REDCap, which will be programmed to check data at the time of entry to ensure that 
entered values are within the specified range and that items are not inappropriately 
skipped. Questionnaire and audio recorded data will be imported directly into a 
password-protected data file stored on the Emory University server. The server is 
protected by the Emory network, and a secured log-in is required from all users. 
17. Provisions to Monitor the Data to Ensure the Safety of Participants
We will establish a Data and Safety Monitoring Plan that consists of the PI and the 
biostatistician on the project. All data will be collected using computerized self-report 
questionnaires or recorded interviews. Only participants’ study identification codes will 
be inputted into computer-based databases. The codes that link the name of the 
participant and the study ID will be kept confidential in a secured cabinet. The self-
report measures will be administered via REDCap, which will be programmed to check 
data at the time of entry to ensure that entered values are within the specified range 
and that items are not inappropriately skipped. The data will be imported directly into a 
password-protected data file stored on the Emory University server. The server is 
protected by the Emory network, and a secured log-in is required from all users.

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In order to ensure the integrity and validity of the data, 
 will conduct 
ongoing review of reports that describe study operations and present data by site to 
ensure that problems are identified and corrected in a timely manner. The following 
reports will be generated for routine review:

Screening, recruitment, enrollment, and retention reports by each recruitment 
site

Protocol compliance reports to identify protocol deviations by each recruitment 
site

Data quality reports – describe missing, erroneous, and inconsistent data to 
ensure protocol is followed and deviations are tracked by each recruitment site

Identification/reporting of serious adverse events

Quarterly visits to clinical sites to review study procedures
If data quality and integrity issues are uncovered, the following correction processes will 
occur:

If the quality of the data compromised, an audit of all related data will be 
conducted by 
.

If systematic errors are uncovered, 
 will review these errors and 
update the protocol (with IRB approval) to address the cause of the systematic 
errors.

If detection processes are not adequately discovering issues related to data 
quality, new processes will be developed to adequately detect data quality 
issues.

If systematic protocol violations are occurring, staff will be retrained by 
 
Diligent safety monitoring will be conducted throughout this study in compliance with 
the following required elements of the Emory IRB’s continuing review process: 
1. Tracking of subject accrual (enrollment, drop-outs, demographics) 
2. Timely and appropriate reporting of informed consent process deficiencies, 
protocol deviations, privacy breaches, conflicts of interest, and/or changes in 
personnel 
3. Ongoing monitoring and appropriate reporting of adverse event activity 
including:
a. frequency of unanticipated, internal, related or possibly related, and 
serious or more prevalent than expected adverse events 
b. frequency of deaths occurring during the study or within 30 days of study 
termination, even if expected or unrelated
4. interim assessment of risk/benefit relationship in reference to adverse event 
occurrences, preliminary observations, and emerging information 

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5. Timely and appropriate IRB submission of safety-related documents such as 
audit reports, sponsor progress reports, and other materials or communications 
that might impact the safe conduct of this study 
6. Active cooperation with the IRB and other applicable entities in the event of a 
random or for-cause internal or external audit
The PI and biostatistician will meet quarterly to review data quality and safety events, 
including any protocol deviations, and to adjudicate adverse events as required by the 
IRB. Additionally, participant safety monitoring will occur at each follow-up study visit. 
The PI will provide a summary of the DSM report to NHLBI on an annual basis. The DSM 
report will include the participants’ socio-demographic characteristics, expected versus 
actual recruitment rates, any quality assurance or regulatory issues that occurred during 
the past year, summary of adverse events, and any actions or changes with respect to 
the protocol. The DSM report to NHLBI will also include, when available, the results of 
any data analyses.
18. Provisions to Protect the Privacy Interests of Participants and Confidentiality of 
Participants’ identifiable data
Participants will interact with the research coordinator during recruitment, the informed 
consent process and data collection. Recruitment will occur via the phone or in-person 
in a private area of the waiting room. Informed consent and data collection tasks will be 
carried out in a private research room (in-person visits) or on a password-protected 
Zoom videoconference. There will be no other individuals interacting with or observing 
the participants. The PI and/or Co-I, who may be familiar with participants from their 
time receiving treatment in the clinic, will also interact with participants to answer 
study-related questions as needed. All questions will be answered in a private setting in 
order to reduce the risk of observation by anyone not participating in the research.
Only the PI, Co-I, and research coordinator will be able to access the participants’ 
medical for the sole purpose of determining eligibility. Only the authorized study team 
on this proposal will have access to study-related data. All study staff will complete 
biomedical or socio-behavioral training through the Collaborative IRB Training Initiative 
Program (CITI). Data will be stored on the Emory servers in password-protected files.
To ensure participant confidentiality, study identification numbers will be assigned to 
each participant and used throughout the duration of the study when referring to 
subjects. The codes that link the name of the participant and the study identification 
number will be kept confidential by the PI in a secured cabinet. Only the authorized 
study team with appropriate training will have access to the data. All identifiers, 
including audio files, will be destroyed after completion of data analysis and manuscript 
publication.
19. Economic Burden to Participants

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Individuals will not incur any medical costs by participating in the proposed study. Costs related 
to transportation for study visits (i.e. vehicle fuel) are expected; however, participants will be 
compensated as follows: 

Aim 1: AYA and HCP subjects will receive a $25 gift card. 

Aim 2: AYA subjects will receive a $50 gift card.

Aim 3: AYA will receive up to $60 and HCPs will receive $25. AYA participants will receive 
reimbursement/compensation for travel costs.
20. Consent Process
Written informed consent will be obtained for all individuals 18 years and older. For 
patients under the legal age of consent (17 years and younger), written assent and 
parental permission will be obtained if the parent or guardian is present in clinic. If the 
parent or guardian is not present in clinic, and contacting them to consent to the 
research would violate the adolescent’s right to privacy regarding certain sexual health 
services, we will invoke the Waiver of Parental Permission given this study poses no 
more than minimal risk. For those visiting the clinic in person, patients and their 
parent/legal guardian (if present) will be approached either via the pre-visiting 
screening and recruitment process or in the waiting room of each recruitment site to 
see if they are interested. In either case, the research coordinator will carry out the 
consent/assent process in a private room (research room) of the clinic. For those visiting 
the clinic via telemedicine, the physician will ask patients and their parent/legal 
guardian (if present) if they are interested in receiving more information about the 
research study at a later time. If so, the research coordinator will schedule a time to 
contact the potential participants and carry out consent/assent procedures using a 
password-protected Zoom videoconference. The consent process will take 
approximately 15 minutes. If the eligible participant or the parent/legal guardian has 
any questions about the study, they will be answered at this time. In order to minimize 
the possibility of coercion or undue influence, the consent process will be carried out by 
the research coordinator, who has no influence on or connection to the medical care 
received by the patients. The research coordinator will not obtain a written signature for 
consent until the entire study has been explained and all questions have been 
answered. 
Non-English-Speaking Participants  
The data collection instruments used in the study will be written in English. Therefore, it 
will be inappropriate to include subjects who are not proficient in English. This is not to 
say that the research topic does not apply to adolescents who are not proficient in 
English; however, addressing these populations within the proposed study would not be 
possible. 

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Participants who are not yet adults (infants, children, teenagers)  
Prospective participants who have not attained the legal age for consent (e.g. 
individuals under the age of 18 years), as determined by the age in their medical record, 
will be required to give written assent. Written parental permission will also be obtained 
for these individuals if the parent or guardian is present. Parental 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. Only parents or legal guardians listed in the child’s medical record will be able to 
provide permission. If the parent or guardian is not present, we will not contact them 
for the sole purpose of informed consent as doing so may violate the adolescents’ right 
to private healthcare for certain sexual health services. We will instead present the 
participant with a consent form that provides enough information for the subject to 
make an informed decision. Given this study includes no more than minimal risk, we 
have applied for a Waiver of Parental Permission as permitted under permitted under 
45 CFR 46.408(c) for those patients under 18 years of age who present alone for a visit 
for reproductive health visits. 
21. Setting
Participants will be recruited from the CHOA Hughes Spalding Adolescent Medicine 
Practice and the Grady Health Teen Clinic Program. For patients visiting the clinics in 
person, recruitment procedures will take place either before the visit using the 
screening and recruitment phone call or in the waiting rooms of each clinic, while 
consent/assent and study procedures will take place in a private office. For patients 
visiting the clinics virtually (telemedicine) recruitment, consent, and study procedures 
will take place via Zoom videoconferencing (password-protected). Participants who 
agree to participate in the intervention in Aim 3 will attend a study visit at the Emory 
Children’s Center Research Unit.
A CHOA community advisory board will be made available to us. The advisory board 
consists of local business, community and nonprofit leaders who are not only dedicated 
to community service, but also focused on the needs and well-being of children in their 
communities. Board members work as advocates and liaisons between the community 
and Children's.
22. Resources Available
The CHOA Hughes Spalding Adolescent Medicine Practice serves approximately 2000 
adolescents ages 13-21 years of age annually for primary care wellness visits, as well as 
consultative behavioral/mental health and reproductive health visits. The Grady Teen 
Clinic, a Title X funded family planning program, provides a dedicated teen-friendly 
space to both male and female adolescents ages 12 through 20 years and serves 
approximately 1500 adolescents annually. For the proposed study, we will need to 

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recruit 60 AYA participants ages 13-21 years over the course of one year. We will devote 
three days out of the week to recruitment in order to reach our recruitment goal. 
Both medical and psychological resources are available to participants who 
experience anticipated consequences of human research. 
, the project PI, is 
a provider at the CHOA Adolescent Medicine practice and can provide research-related 
care to patients at the recruitment site, as needed. Additionally, 
, the project 
Co-I, is a provider at the Grady Health Teen Program and can provide research-related 
care to patients at the recruitment site, as needed. The Adolescent Medicine practice 
also has two additional medical doctors, a nurse practitioner, and a licensed 
psychologist who will be made aware of the research study and will be able to provide 
care as needed to patients experiencing any stress identified via the research protocol. 
The Grady Health Teen Program has an additional medical doctor, a nurse practitioner, 
and a health educator/case manager who will be made aware of the research study and 
will be able to provide care as needed to patients experiencing any stress identified via 
the research protocol.
All persons assisting with the research will be adequately informed about the 
protocol, research procedures, and their duties and functions. Furthermore, all persons 
assisting with the research will receive appropriate CITI training
23. References
1. 
Benjamin EJ, Muntner P, Alonso A, et al. Heart Disease and Stroke Statistics-2019 
Update: A Report From the American Heart Association. Circulation. 2019. 
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2. 
Bucholz EM, Gooding HC, de Ferranti SD. Awareness of Cardiovascular Risk Factors in U.S. 
Young Adults Aged 18-39 Years. Am J Prev Med. 2018. doi:10.1016/j.amepre.2018.01.022
3. 
Laitinen TT, Pahkala K, Magnussen CG, et al. Lifetime measures of ideal cardiovascular 
health and their association with subclinical atherosclerosis: The Cardiovascular Risk in 
Young Finns Study. Int J Cardiol. 2015;185:186-191. doi:10.1016/j.ijcard.2015.03.051
4. 
Davis PH, Dawson JD, Riley WA, Lauer RM. Carotid intimal-medial thickness is related to 
cardiovascular risk factors measured from childhood through middle age: The Muscatine 
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5. 
Laitinen TT, Pahkala K, Venn A, et al. Childhood lifestyle and clinical determinants of adult 
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Laitinen TT, Pahkala K, Magnussen CG, et al. Ideal cardiovascular health in childhood and 
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Bibbins-Domingo K, Burroughs Pena M. Caring for the “young invincibles.” J Gen Intern 
Med. 2010;25(7):642-643. doi:10.1007/s11606-010-1388-8
8. 
Steinberg L. Risk taking in adolescence: new perspectives from brain and behavioral 

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science. Curr Dir Psychol Sci. 2007;16(2):55-59.
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Steinberg L, Graham S, O’Brien L, Woolard J, Cauffman E, Banich M. Age differences in 
future orientation and delay discounting. Child Dev. 2009;80(1):28-44. doi:CDEV1244 
[pii]10.1111/j.1467-8624.2008.01244.x
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Gooding HC, Sheldrick R, Leslie LK, Shah S, De Ferranti SD, Mackie TI. Adolescent 
perceptions of cholesterol screening results: “young invincibles” or developing adults? J 
Adolesc Heal. 2016;59(2):162-170.
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Gooding HC, Brown CA, Liu J, Revette AC, Stamoulis C, de Ferranti SD. Will Teens Go Red? 
Low Cardiovascular Disease Awareness Among Young Women. J Am Heart Assoc. 2019. 
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Warnick JL, Pfammatter A, Champion K, Galluzzi T, Spring B. Perceptions of Health 
Behaviors and Mobile Health Applications in an Academically Elite College Population to 
Inform a Targeted Health Promotion Program. Int J Behav Med. 2019;26(2):165-174. 
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13. 
Oosterveen E, Tzelepis F, Ashton L, Hutchesson MJ. A systematic review of eHealth 
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obesity for young adults. Prev Med (Baltim). 2017;99:197-206. 
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Fortuna RJ, Robbins BW, Halterman JS. Ambulatory care among young adults in the 
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Glanz K, Rimer BK, Viswanath K E. Social and Behavioral Theories.; 2008.