Congenital Heart Disease Physical Activity Lifestyle Study
Phase: NA
Conditions: Cardiovascular Disease Other, Physical Activity
Sponsor: Jamie Jackson

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Congenital Heart Disease Physical Activity Lifestyle Study (CHD-PALS) 
 
 
Principal Investigator:  Jamie L. Jackson 
 
 
Center for Biobehavioral Health 
The Research Institute at Nationwide Children's Hospital 
Nationwide Children's Hospital 
 
Assistant Professor of Pediatrics 
The Ohio State University College of Medicine 
 
Assistant Professor of Psychology 
The Ohio State University College of Liberal Arts and Sciences 
 
 
Version 7 
 
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STATEMENT OF COMPLIANCE 
The study will be carried out in accordance with Good Clinical Practice (GCP) as required by the following: 
 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46; 21 CFR 
Part 50, 21 CFR Part 56, and 21 CFR Part 312) 
 
ICH E6; 62 Federal Register 25691 (1997)  
 
NIH Clinical Terms of Award 
 
All key personnel (all individuals responsible for the design and conduct of this study) have completed Human 
Subjects Protection Training. 
 

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SIGNATURE PAGE 
The signature below constitutes the approval of this protocol and the attachments, and provides the necessary 
assurances that this trial will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US federal 
regulations. 
 
Site Investigator:* 
 
Signed: 
 
Date: 
9/26/2019 
 
Name 
Title 
 
 
 
* The protocol should be signed by the local investigator who is responsible for the study implementation at his/her 
specific site. 

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TABLE OF CONTENTS 
 
                                                                                                                                           Page 
Statement of Compliance ................................................................................................................ ii 
Signature Page ............................................................................................................................... iii 
Table of Contents ............................................................................................................................ iv 
List of Abbreviations ....................................................................................................................... vi 
Protocol Summary ......................................................................................................................... vii 
1 
Key Roles ............................................................................................................................. 10 
2 
Background Information and Scientific Rationale ............................................................... 11 
2.1 
Background Information ........................................................................................... 11 
2.2 
Rationale .................................................................................................................. 14 
2.3 
Potential Risks and Benefits .................................................................................... 16 
2.3.1 
Potential Risks ............................................................................................. 16 
2.3.2 
Known Potential Benefits ............................................................................. 18 
3 
Objectives ............................................................................................................................ 19 
3.1 
Study Objectives ...................................................................................................... 19 
3.2 
Study Outcome Measures ....................................................................................... 19 
3.2.1 
Primary Outcome Measure .......................................................................... 19 
3.2.2 
Secondary Outcome Measures ................................................................... 19 
3.2.3 
Other Outcome Measures ........................................................................... 20 
3.2.4 
Purported Mechanisms ................................................................................ 20 
3.2.5 
Other Exploratory Predictors ....................................................................... 20 
4 
Study Design ........................................................................................................................ 21 
5 
Study Enrollment and Withdrawal ....................................................................................... 23 
5.1 
Participant Inclusion Criteria .................................................................................... 23 
5.2 
Participant Exclusion Criteria ................................................................................... 24 
5.3 
Treatment Assignment Procedures ......................................................................... 24 
5.3.1 
Randomization Procedures ......................................................................... 24 
5.3.2 
Reasons for Withdrawal ............................................................................... 25 
5.3.3 
Handling of Withdrawals .............................................................................. 25 
5.3.4 
Termination of Study .................................................................................... 25 
5.4 
Study Intervention Description ................................................................................. 26 
5.5 
Modification of Study Intervention ........................................................................... 26 
5.6 
Accountability Procedures for the Study Intervention ............................................. 26 
5.7 
Assessment of Subject Compliance with Study Intervention .................................. 27 
5.8 
Concomitant Treatments ......................................................................................... 27 
6 
Study Schedule, Study Procedures/ Evaluations ................................................................ 28 
6.1 
Screening ................................................................................................................. 28 
6.2 
Phase 1: Enrollment/Baseline (T1) .......................................................................... 28 
6.3 
Phase 2: Enrollment in the RCT .............................................................................. 29 
6.4 
Interim Assessment (between weeks 8-12) ............................................................ 30 

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6.5 
Post-Intervention (between weeks 20-26) ............................................................... 30 
6.6 
Focus Groups (after post-intervention assessment) ............................................... 31 
6.7 
6-Month Follow-up (between weeks 46-50) ............................................................ 32 
6.8 
Additional Incentive .................................................................................................. 32 
7 
Assessment of Safety .......................................................................................................... 33 
7.1 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters33 
7.1.1 
Adverse Events ............................................................................................ 33 
7.1.2 
Procedures to be Followed in the Event of Abnormal Test Values or 
Abnormal Clinical Findings .......................................................................... 35 
7.2 
Reporting Procedures .............................................................................................. 36 
7.2.1 
Adverse Events ............................................................................................ 36 
7.2.1 
Serious Adverse Events .............................................................................. 36 
7.2.2 
Unanticipated Problems ............................................................................... 36 
7.3 
Type and Duration of Follow-up of Subjects after Adverse Events ........................ 36 
7.4 
Halting Rules ............................................................................................................ 37 
7.5 
Safety Oversight ...................................................................................................... 37 
7.6 
Study Hypotheses .................................................................................................... 37 
7.7 
Sample Size Considerations ................................................................................... 38 
7.8 
Planned Interim Analyses (if applicable) ................................................................. 38 
7.9 
Analysis Plan............................................................................................................ 38 
8 
Source Documents and Access to Source Data/Documents ............................................. 41 
9 
Quality Control and Quality Assurance ............................................................................... 42 
10 
Ethics/Protection of Human Subjects .................................................................................. 43 
10.1 
Ethical Standard ....................................................................................................... 43 
10.2 
Institutional Review Board ....................................................................................... 43 
10.3 
Informed Consent Process ...................................................................................... 43 
10.3.1 Informed Consent/Assent Process (in Case of a Minor) ............................. 44 
10.4 
Subject Confidentiality ............................................................................................. 44 
10.5 
Study Discontinuation .............................................................................................. 44 
11 
Data Handling and Record Keeping .................................................................................... 45 
11.1 
Data Management Responsibilities ......................................................................... 45 
11.2 
Data Capture Methods ............................................................................................. 45 
11.3 
Types of Data ........................................................................................................... 46 
11.4 
Study Records Retention ......................................................................................... 46 
11.5 
Protocol Deviations .................................................................................................. 46 
12 
Publication Policy ................................................................................................................. 47 
13     PHI Recording……………………………………………………………………………………..49 
14     Temporary Changes in Protocol in Response to COVID-19…………………………………52 
15 
Literature References .......................................................................................................... 54 

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LIST OF ABBREVIATIONS 
AHA 
American Heart Association 
IPAQ 
International Physical Activity Questionnaire 
IRB 
Institutional Review Board 
CHD 
Congenital Heart Disease 
CHD-PALS 
Congenital Heart Disease Physical Activity Lifestyle Study 
CITI 
Collaborative Institutional Training Initiative 
CO-I 
Co-Investigator 
DSMB 
Data Safety Monitoring Board 
Mplus 
Statistical Modeling Program 
MVPA 
Moderate to Vigorous Physical Activity 
NCH 
Nationwide Children’s Hospital 
PA 
Physical Activity 
PI 
Principal Investigator 
PROMIS 
Patient-Reported Outcomes Measurement Information System  
SB 
Sedentary Behavior 
RCT 
Randomized Control Trial 
REDCap 
Research Electronic Data Capture 
VO2max 
Peak Oxygen Uptake 
 
 
 
 

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PROTOCOL SUMMARY 
Title: 
Congenital Heart Disease Physical Activity Lifestyle Study 
(CHD-PALS) 
 
 
Abstract: 
Over 40,000 infants are born in the U.S. with congenital heart disease (CHD) 
each year, and with advancements in medicine, more than 90% of these 
individuals now live well into adulthood. This growing, and aging, population of 
CHD survivors is at risk for developing cardiac-related complications such as 
coronary disease, heart failure, and hypertension, which fortunately are 
responsive to lifestyle change. An American Heart Association (AHA) Scientific 
Statement highlights the important health benefits gained from increasing 
physical activity (PA) among children and adults with CHD, noting research 
evidence of better vascular health, reductions in hypertension, and lower rates 
of obesity. Despite this, evidence suggests that CHD survivors are less active 
than healthy controls, placing them at an elevated risk for preventable 
morbidity and premature mortality. Therefore, the currently study adapts a PA 
lifestyle intervention to adolescent CHD survivors (ages 15-18) who have 
moderate to complex CHD with the goal of increasing MVPA and decreasing 
SB. The study is split into 2 phases; a total of 90 adolescent and caregiver 
dyads will participate in Phase 1 to determine participants’ eligibility for Phase 
2. Phase 2 is the randomized controlled trial in which a total of 70 adolescents 
are randomized to either the comparison arm (Fitbit and exercise prescription) 
or the intervention arm (Fitbit, exercise prescription, AND videoconferencing 
sessions with a coach). 
 
 
Population: 
Participants: For Phase 1 we aim to recruit 90 adolescents (ages 15 – 18 at 
enrollment) who have moderate to complex CHD, along with caregivers. For 
Phase 2 we aim to recruit 70 adolescent and caregiver dyads (35 per arm). 
 
 
Study Duration: 
4 years (2017-2021) 
 
 
Participation Duration: 
Phase 1:  2 weeks 
Phase 2: 22 weeks with a 6-month follow-up assessment 
 
 
Description of the 
Intervention: 
Phase 2 of the study consists of being randomized into one of two arms; the 
comparison arm receives a Fitbit and an exercise prescription based on the 
results of the Phase 1 stress test. The intervention arm receives a Fitbit, an 

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exercise prescription, and 8 videoconferencing sessions with a PA coach, 
which takes place over 20 weeks. Each session lasts 20-30 minutes and 
focuses on changing attitudes, perceptions of social norms, and perceptions of 
control over for engaging in PA, based on the principles of the Theory of 
Planner Behavior.   
 
 
Objectives: 
 
The long-term goal of this research study is to establish an effective 
intervention for sustaining increased levels of MVPA that will reduce 
morbidity and healthcare costs for CHD survivors. The objective of this 
study is to adapt a lifestyle PA intervention to transition-age adolescent and 
emerging adult CHD survivors at greater risk for future morbidity due to 
having more complex disease. This will involve (1) assessing feasibility of 
the intervention to participants based on subjective ratings and objective 
recruitment and retention information, as well as (2) evaluating preliminary 
efficacy of the intervention on time spent in MVPA and SB, as well as 
improvement in cardiorespiratory fitness as assessed by changes in VO2max. 
We hypothesize that (1) participants will positively rate the intervention on 
multiple dimensions, including easy to access, enjoyable, and pertinent. 
Additionally, recruitment and retention rates are predicted to be >75%. We 
also predict that (2) participants in the intervention arm will (A) increase 
MVPA (primary outcome), (B) decrease SB (secondary outcome), and (C) 
demonstrate an increase in VO2max (secondary outcome) at post-
intervention relative to those in the comparison arm. The rationale for the 
proposed research is to obtain pilot data that will shape the next phase of 
investigation: determining the efficacy of this intervention for sustaining 
increased PA. Ultimately, we hope that knowledge gained from this line of 
research will extend longevity and optimize quality of life for CHD survivors 
as they age into adulthood.  
 
 
Description of Study 
Design: 
Randomized controlled trial with two treatment arms: (1) Comparison arm: 
Fitbit, exercise prescription and (2) Intervention arm: Fitbit, exercise 
prescription, and 8 videoconferencing sessions with a PA coach over the 
course of 20 weeks.  
 
 
Estimated Time to 
Complete Enrollment 
(n=90): 
3 years 

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1 
KEY ROLES 
Individuals: 
 
 
Principal Investigator:  Jamie L. Jackson, Ph.D. 
Primary Mentor/Co-investigator: Kathryn Vannatta, Ph.D.   
Mentors/Co-investigators: Joseph Rausch, Ph.D., Vidu Garg, M.D. 
Consultants: Rick Petosa, Ph.D., Laureen Smith, Ph.D. 
Associate Director, Behavioral Trials Office: Kelly Boone, M.A., CCRP 
 
Institution: 
 
 
 
Center for Biobehavioral Health 
The Research Institute at Nationwide Children’s Hospital 
700 Children’s Drive 
Columbus, OH 43205 
Phone 614-722-3585 
 

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2 
BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE 
2.1 
Background Information 
 
Congenital heart disease (CHD) comorbidities and cost  
Over 40,000 infants are born in the U.S. with CHD each year, and with advancements in medicine, 
more than 90% of these individuals now live well into adulthood.1-3 This growing, and aging, 
population of CHD survivors are at risk for developing cardiac-related complications such as 
coronary disease, heart failure and hypertension, which fortunately are responsive to lifestyle 
change.4 More than half of children and adolescents with surgically corrected CHD have signs of 
intimal hyperplasia, an atherosclerosis precursor, highlighting the importance of early intervention.5 
Those with moderate and complex cardiac lesions4 are the ones in greatest need for intervention, 
as evidenced by significantly higher premature mortality rates as compared to the general 
population due to underlying cardiovascular issues.6 Increased rates of hospitalizations costing 
more than $3.16 billion annually due to higher incidence of coronary artery disease and heart failure 
among CHD survivors can be mitigated by early lifestyle intervention.7  
 
Physical activity (PA) engagement and benefits  
An American Heart Association (AHA) Scientific Statement8 highlights the important health benefits 
gained from increasing PA among children and adults with CHD, noting research evidence of better 
vascular health, reductions in hypertension and lower rates of obesity. Positive health behaviors 
often decline during adolescence and emerging adulthood, and adolescents with CHD are no 
exception, which may lead to poor health behaviors in adulthood.9-12 Furthermore, declines in PA 
are greater among girls, especially during adolescence.12,13 Similar sex differences have been 
reported among adolescents with CHD, such that males demonstrate higher cardiopulmonary 
exercise tolerance than females.14 Therefore, adolescence and emerging adulthood are an optimal 
developmental time during which to intervene by changing lifestyle habits, such as PA, to prevent 
greater morbidity in through adolescence into adulthood. 
 
Sedentary behavior (SB) is a risk factor  
In addition to promoting moderate to vigorous physical activity (MVPA), a scientific statement by 
the AHA8 also noted the importance of decreasing SB. Emerging evidence has identified 
inactivity as an equally important independent risk factor for cardiovascular complications, even 
when guidelines for PA are met. Among healthy children, SB increases by approximately 30 
minutes per year from childhood into adolescence due to more time spent watching TV and/or 

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using computers.15 Rates of SB among CHD survivors have not been documented, despite 
evidence suggesting that parents of children with CHD may unnecessarily restrict PA at early 
ages,16 possibly resulting in greater SB. Therefore, SB may be an equally important target for a 
lifestyle intervention. Consequently, in addition to measuring MVPA the current study will also 
measure SB, as a secondary outcome, due to the evidence of poor health outcomes with a 
predominantly sedentary lifestyle.   
 
Physical Activity interventions and the Theory of Planned Behavior  
PA interventions among CHD survivors across the lifespan have primarily focused on structured 
exercise programs, often using a cardiac rehabilitation model (3 days/week for 12 weeks). A 
systematic review of exercise training programs among children and young adults with CHD 
indicated that exercise training was safe and improved fitness levels, including among those with 
complex cardiac lesions, but the long-term sustainability is relatively unknown.17 Of the 4 studies 
reviewed that included long-term follow-up, only 1 found a sustained effect, which was up to 5 years 
post-training. Of the other 3 studies, 1 did not find sustained effects and 2 only included survivors 
referred for cardiac rehabilitation, which limits applicability since many with CHD are never referred 
for cardiac rehabilitation. Interventions aimed at modifying lifestyle behaviors attempt to change 
long-term behavior by creating new positive habits rather than emphasize adherence to a time-
limited structured program. The Theory of Planned Behavior18 has been used as a framework for 
lifestyle interventions, including among individuals with heart failure,19-21 rural populations with 
multiple cardiovascular risk factors,22 and adolescents.23 Among internet-based interventions, the 
Theory of Planned Behavior has been identified as having larger effect sizes than other Health 
Behavior Theories for adolescents.24 The Theory of Planned Behavior contains 3 primary elements 
hypothesized to contribute to behavior change: attitudes about the behavior, subjective norms and 
perceived control. Interventions using this theory aim to address knowledge deficiencies and 
negative perceptions of the behavior (attitude), increase perception of others’ approval of the 
behavior, such as family members, peers and medical staff (subjective norm), as well as trouble-
shoot barriers while increasing efficacy (perceived control). This framework may be particularly 
useful for CHD survivors since low PA in this population has been attributed to inaccurate negative 
attitudes about the consequences of PA on the heart or need for activity restriction by caregivers 
and others (e.g., sports coaches) during childhood.25,26  
 
Objective measures to assess physical activity (PA)  
Two studies have reported time spent in MVPA among adolescents with CHD as measured by 
accelerometer. Duppen and colleagues (2015)27 stated that only 30% of their sample did not 
meet guidelines for MVPA (>60 min/day), which contrasts a study by Morrison et al. (2013)28 in 
which adolescents averaged 29 min/day in MVPA. Duppen et al.,27 noted that cultural and 

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geographic differences may explain discrepancies within the literature, further highlighting the 
importance of identifying rates of MVPA among adolescents in the U.S., of which the literature is 
completely lacking. Only 27% of “healthy” U.S. adolescents from the general population report 
any form of daily PA,29 suggesting that a large portion of adolescent CHD survivors in the U.S. 
are also relatively inactive, despite being at greater risk for poor health outcomes. A similar 
picture emerges from studies on adult CHD survivors. Dua et al. (2007) documented that among 
young adult (age 31.7+11.0) CHD survivors in the United Kingdom, only 23% who reported no 
functional impairments met national guidelines of at least 30 min/day of moderate intensity PA.30 
Sandberg et al. (2016) found that only 50% of Swedish adult CHD survivors (age was 
undefined) met the World Health Organization’s recommendations for PA, which was true for 
both CHD survivors and age- and sex-matched controls.31 McKillop et al. (2018) reported similar 
averages for min spent in MVPA, as did Dua and colleagues (26 min) on a small Canadian 
sample of 15 emerging adults.32Only 21% of U.S. adults from the general population meet the 
Centers for Disease Control and Prevention guidelines of at least 150 min/week of moderate 
intensity aerobic activity.29 This suggests that a large portion of adult CHD survivors in the U.S. 
are also likely to be relatively inactive, despite being at greater risk for poor health outcomes. 
 
These studies also draw attention to the need for using objective measures of PA to inform 
interventions, including using time spent in MVPA, as assessed by an accelerometer, for 
inclusion criteria so that adolescents and emerging adults in need of intervention are targeted. 
In the current study, objective measures of MVPA will also be used to stratify random 
assignment of participants, as well as included as covariates in study analyses, thereby 
improving scientific rigor as compared to previous studies. This strategy will allow the detection 
of group differences with fewer participants and is in accordance with guidelines for clinical 
trials.33 The current study will also examine change in peak oxygen uptake (VO2max), a measure 
of exercise tolerance, as a secondary outcome. VO2max has been identified as an independent 
predictor of 5-year mortality in young adult CHD survivors.34 While change in VO2max has been 
commonly assessed as an outcome in cardiac rehabilitation-style exercise interventions for 
CHD survivors, increased MVPA may not result in improved cardiorespiratory fitness. Current 
guidelines indicate that increasing moderate PA has significant health benefits, even in the 
absence of change in VO2max.  
 
Utilizing technology to facilitate behavior change: Videoconferencing and a popular 
activity tracker (Fitbit®) 
Videoconferencing behavioral interventions have demonstrated feasibility in other adolescent 
chronic illness populations, including diabetes35,36 and inflammatory bowel disease,36 as well as 
among adults at risk for cardiovascular disease.37 Videoconferencing as a mode of delivery for 

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behavioral interventions has multiple advantages, such as eliminating some barriers to receiving 
the intervention (e.g., transportation, distance) and reducing costs for both providers and 
patients. Furthermore, videoconferencing and other modes of telehealth delivery have been 
shown to result in comparable rapport-building between youth and clinicians as face-to-face 
interventions and are accepted by families.38 A Fitbit will be used in the current study as part of 
the intervention so that participants receive moment-to-moment feedback on their PA. 
Commercially available activity trackers, such as Fitbit, are popular and have been shown to 
align well with Health Behavior Theories because they offer immediate feedback and have 
tailored goal-setting functions.39 Fitbits have been used with adolescents to track sleep,40,41 and 
PA42 in children with complex CHD as well as promote PA as part of an intervention with 
children with cancer.43  
 
2.2 
Rationale 
 
If adolescents with moderate to complex forms of CHD demonstrate preliminary evidence of 
benefitting from a PA lifestyle intervention grounded in the Theory of Planned Behavior, this 
may inform future intervention studies aimed at increasing levels of moderate to vigorous PA 
over time. 
 
With more than 50% of children and adolescents with surgically corrected CHD having early 
signs of atherosclerosis,5 and little research identifying effective interventions to sustainably 
increase PA, there is a tremendous need for research on lifestyle interventions for this 
population. Identification of a lifestyle intervention to increase PA in CHD survivors is vital for 
reducing morbidity and improving quality of life. Interventions grounded in the Theory of Planned 
Behavior have demonstrated sustained increases in PA among other populations, including 
individuals with heart failure19-21 and rural populations with multiple cardiovascular disease risk 
factors22. One PA lifestyle intervention using Social Cognitive Theory among adolescents with 
CHD was proposed in 2012, but results have yet to be published.44 Morrison and colleagues 
(2013)28 reported improved PA among adolescents with CHD after a 1-day group intervention 
conducted in a “motivational interview style” accompanied by monthly follow-up calls (6 
months). Motivational interviewing addresses attitudes towards a behavior, self-efficacy and 
overcoming barriers, not unlike Theory of Planned Behavior. However, recruitment rates for 
Morrison et al.’s study were low (31.4%), which questions the generalizability of the findings, 
and cardiorespiratory fitness was not directly measured (VO2max). Due to the paucity of 
theoretically-driven interventions to improve lifestyle PA among CHD survivors, The Theory of 
Planned Behavior will be used as the current framework for this study. This theory will allow the 

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identification of potential mechanisms of behavior change, such as attitudes, subjective norms 
and perceived control. Understanding the circumstances in which change is more likely to 
occur, or the mechanisms by which it occurs, will guide both development and modification of 
the intervention to achieve enhanced effects in a larger clinical trial. 
 
Thus, the long-term goal of this research study is to establish an effective intervention for 
sustaining increased levels of MVPA that will reduce morbidity and healthcare costs for CHD 
survivors. The objective of this study is to adapt a lifestyle PA intervention to transition-age 
adolescent CHD survivors who are at greater risk for future morbidity due to having more 
complex disease. This will involve (1) assessing feasibility of the intervention to participants 
based on subjective ratings and objective recruitment and retention information, as well as (2) 
evaluating preliminary efficacy of the intervention on time spent in MVPA and SB, as well as 
improvement in cardiorespiratory fitness as assessed by changes in VO2max. With the 
hypothesis that (1) participants will rate the intervention as not burdensome, easy to access, 
and appealing. Additionally, recruitment and retention rates are predicted to be >75%. We also 
hypothesize that (2) participants in the intervention arm will (A) increase MVPA, (B) decrease 
SB, and (C) demonstrate an increase in VO2max at post-intervention relative to those in the 
comparison arm. The rationale for the proposed research is to obtain pilot data that will shape 
the next phase of investigation: determining the efficacy of this intervention for sustaining 
increased PA. Ultimately, we hope that knowledge gained from this line of research will extend 
longevity and optimize quality of life for CHD survivors as they age further into adulthood.  
 
Eligible participants are 15 to 18 years of age with moderate to complex CHD. This is because 
individuals with moderate and complex cardiac lesions are the ones in greater need for 
intervention, as evidenced by significantly higher premature mortality rates as compared to the 
general population due to underlying cardiovascular issues.6 Participants in the comparison arm 
receive a Fitbit and an exercise prescription, as well as complete the baseline, interim, and post-
intervention and 6-month follow-up assessments. In addition to the Fitbit and exercise 
prescription, Participants in the intervention arm receive 8 20-30 min videoconferencing 
sessions (i.e. FaceTime, Google Hangouts or Skype) with a PA coach, which take place over 
the course of 20 weeks. Intervention arm participants will also be invited to partake in a focus 
group, which will be held via videoconferencing (4-6 focus groups with 6-8 participants in each 
group). 
 
Using the Theory of Planned Behavior as a guide, intervention sessions focus on changing 
attitudes, perceptions of social norms, and perceptions of control towards PA. This theory was 
chosen given its larger effect size in internet-based interventions for adolescents when 

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compared to other health behavior theories.24 For the intervention arm, the Fitbit is used to 
facilitate goal-setting and self-monitoring while working with the PA coach. These have been 
used to track and promote children and adolescents PA in other interventions.42,43 
 
2.3 
Potential Risks and Benefits 
2.3.1 Potential Risks 
 
The current research study complies with the federal regulations definition of “minimal risk” [§45 
CFR 46.102(i)] “that the probability and magnitude of harm or discomfort anticipated in the 
research are not greater, in and of themselves, than those ordinarily encountered in daily life or 
during the performance of routine physical or psychological examinations or tests.” 
Consequently, the CHD-PAL Study was reviewed by the NCH Institutional Review Board under 
§45 CFR 46.404 “Research not involving greater than minimal risk.”  
 
Exercise training has been established as safe for most CHD survivors and PA promotion in this 
population is highly recommended. Nevertheless, we have designed a protocol that implements 
several safeguards to reduce potential risk. Before a potential participant is approached for 
recruitment, his/her cardiologist is contacted to determine if the adolescent is able to safely 
engage in MVPA. After receiving the cardiologist’s approval and the CHD survivors is recruited, 
then he/she undergoes an exercise stress test to rule out the presence of arrhythmia or cardiac 
ischemia, which would preclude them from engaging in regular MVPA, and therefore exclude 
them from participating in Phase 2 of the study. Exercise stress tests are conducted within the 
same space used for outpatient cardiology clinic and are staffed by at least one cardiologist. As 
part of the exercise stress test protocol, participants are encouraged to reach the limitations of 
their physical capacity, which can be uncomfortable. Thus, participants are told that they may 
experience normal levels of physical discomfort when undergoing the exercise stress test. Upon 
completion of the test, participants are provided with a towel and water, and are monitored by 
clinical staff throughout the duration and recovery of the test. If the exercise stress test results 
demonstrate arrhythmia or cardiac ischemia both the participant and the participants’ primary 
cardiologist are notified. Although learning this information could be distressing to participants or 
their caregivers, identification of an abnormality would have potential benefits to participants as 
well. 
 
Similar to the exercise stress test, participants in the intervention arm may experience 
uncomfortable physical sensations due to exercising, including sore muscles, fatigue, and 
shortness of breath. If the participant has new cardiac-related symptoms since his/her last 

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cardiology check-up that are concerning to the participant and caregiver, the interventionist (i.e. 
PA coaches) will recommend contacting the participant’s cardiologist and the study procedures 
are put on hold until the cardiologist clears the participant to return to the study. The 
interventionist also contacts the study PI, Dr. Jackson, who notifies the participant’s cardiologist 
that the participant is experiencing symptoms.  
 
During videoconferencing, PA coaches conduct sessions in privacy and encourage participants 
to do the same. The same will be encouraged for those who participate in the focus groups. 
Coaches undergo the same training as other research staff at NCH, including completing 
Collaborative Institutional Training Initiative (CITI) certification and a day-long instructional 
seminar on protecting human subjects. Videoconferencing has a lower risk of privacy breach 
than email communications. Should technical difficulties (e.g., WiFi issues, recorder error) occur 
during the videoconferencing sessions, PA coaches will make adjustments in accordance with 
privacy and confidentiality guidelines to conduct the session and/or document the content of the 
session. These adjustments may include (but are not limited to) conducting the session as a 
voice call (in the event of videoconferencing issues) or writing a summary of the session (in the 
event of recorder error). Audio recordings and other documents resulting from these 
adjustments will be stored on the hospital’s secure OneDrive platform. For the purposes of 
identifying and problem-solving common technical difficulties, PA coaches will record all 
videoconferencing, recording, and other technical and practical issues. This record will also help 
identify sessions that may not be available for fidelity evaluation.       
 
Participants are informed that participation is voluntary and that they have the right to withdraw 
from the study at any time, as well as may refuse to answer or may skip any question(s) that 
cause discomfort. While not anticipated, participants could experience some discomfort when 
completing survey items about their heart condition or treatment history. However, this risk is 
very small. If discomfort occurs, it would likely be transient and minimal. Participants are 
encouraged to discuss any concerns about the content of the survey items with study 
personnel, who have experience using these questionnaires and are trained to respond 
appropriately. The more likely risk to participants is boredom while completing the 
questionnaires. 
 
Loss of confidentiality is also a potential risk; though, no more so than in any other research 
study. Risks of breaching confidentiality are minimized in multiple ways. Participants are 
assigned a study ID number, which is used on all questionnaires (paper and online), as well as 
the accelerometer and Fitbit data. The only link between the participant’s name and ID is an 
electronic tracking sheet, which is located on a password protected server on the hospital’s 

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secured research network, as well as on the hospital’s secure Windows OneDrive platform. 
Online questionnaire data and audio recordings of the intervention sessions are housed behind 
a secure firewall on the NCH research internet server and the hospitals secure OneDrive 
platform. All other data are kept in a locked cabinet within a locked office at the hospital and 
only direct study personnel have access to this information. All study personnel who are working 
with data or protected health information are properly trained, which includes completing the 
online CITI certification and undergoing a day-long instructional seminar at the hospital for 
protecting human subjects and engaging in best practices for responsible conduct of research. 
 
2.3.2 Known Potential Benefits 
 
Participants may receive direct benefit from being provided with the results of an exercise stress 
test and exercise prescription. Results are shared with each participant’s cardiologist and entered 
under “research” in their medical record. Participants could also gain benefit from increasing their 
levels of PA. Finally, the information learned from the study could benefit future adolescent and 
adult CHD survivors by possibly identifying a feasible, accessible, and acceptable intervention that 
can improve PA engagement in a population at risk for significant future cardiovascular morbidities. 
 

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3 
OBJECTIVES 
3.1 
Study Objectives 
A total of 90 CHD survivors (ages 15 - 18) and caregivers are anticipated to be enrolled in Phase 1 
of the study, which establishes eligibility for Phase 2. For Phase 2, the randomized trial portion of 
the study, we plan to enroll a total of 50 adolescents and caregivers. The aims of the study are to: 
 
1. Aim 1: Assess feasibility of the intervention to participants based on subjective ratings. 
Hypothesis 1: Participants are hypothesized to rate the intervention as not 
burdensome, easy to access, and appealing. Additionally, recruitment and retention 
rates are predicted to be >75%. 
 
2. Aim 2: Evaluate preliminary efficacy of the intervention on time spent in MVPA and SB, as 
well as improvement in cardiorespiratory fitness as assessed by changes in VO2max.   
Hypothesis 2: Participants in the intervention arm will (A) increase MVPA relative to 
those in the comparison arm at post-intervention, (B) decrease SB relative to those 
in the comparison arm, and (C) demonstrate an increase in VO2max at post-
intervention relative to those in the comparison arm. 
 
3. Aim 3 (Exploratory): Explore mechanisms of change in MVPA and SB, as specified by 
the Theory of Planned Behavior, including attitudes (i.e., knowledge about and belief in 
positive outcomes from PA), normative beliefs (i.e., participant-report of 
family/friend/physician beliefs about and support of PA) and perceived behavioral control 
(i.e., barriers and efficacy for PA).  
 
3.2 
Study Outcome Measures 
3.2.1 Primary Outcome Measure 
Number of minutes spent in MVPA as measured by an accelerometer. 
3.2.2 Secondary Outcome Measures 
Number of minutes spent being sedentary as measured by an accelerometer. 
Maximal oxygen utilization during PA as measured by VO2max during an exercise stress test. 

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3.2.3 Other Outcome Measures 
Health-related quality of life as measured by the Patient-Reported Outcomes Measurement 
Information System (PROMIS).45-47 
Self-reported PA as measured by the International Physical Activity Questionnaire (IPAQ).48,49 
3.2.4 Purported Mechanisms 
 
PA attitudes as measured by the Benefits of PA questionnaire50. 
 
PA subjective norms as measured by the PA Subjective Norms51 and the Social Support for PA52 
surveys. 
  
PA perceived control as measured by the Barriers to Exercise survey53 and the Self-Efficacy for 
Exercise Scale.54 
3.2.5 Other Exploratory Predictors 
 
Cardiac-related anxiety as measured by the Cardiac Anxiety Questionnaire.55 
 
Self-consciousness of body due to cardiac interventions scars as measured by the modified Body 
Image Disturbance Questionnaire.56 
 
Caregiver perceptions of adolescents’ health as measured by the Child Vulnerability Scale.57 
 
Caregiver perceptions of family discord as measured by the Family Environment Scale.58 
 
Caregiver perceptions of adolescents’ PA as measured by the PA Norms survey.51 
Caregiver self-reported PA as measured by the IPAQ.48 
Caregiver health-related quality of life as measured by the PROMIS.45-47 
 

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4 
STUDY DESIGN 
 
This single-site study is a randomized clinical trial of a Fitbit and exercise prescription vs. a Fitbit, 
exercise prescription, AND videoconferencing sessions with a PA coach over the course of 8 
sessions in 20 weeks.  
 
For Phase 1, participants are asked to complete less than 30-45 minutes of questionnaires wear an 
accelerometer for 7 days, and undergo an exercise stress test. A caregiver is asked to complete 20-
30 minutes of questionnaires. Once the exercise stress test is completed and the accelerometer is 
returned, participants are compensated $100. Once caregivers complete the online questionnaires, 
they are compensated $20. Parking and mileage reimbursement to/from the hospital is provided.  
 
If a participant engages in < 60 minutes of MVPA per day and has no contraindications on the 
exercise stress test, he/she is approached for participation in Phase 2. Once recruited, participants 
receive a Fitbit and an explanation of their exercise prescription based on the results of their 
exercise stress test as provided by an exercise physiologist. If the exercise physiologist is not 
available to develop the exercise prescription, the principal investigator, in consultation with the 
study physician, will develop the exercise prescription based on guidelines provided by the exercise 
physiologist. Next, study staff open an envelope (pre-prepared by the study statistician, Dr. Rausch) 
to reveal the participant’s study arm designation. Randomization is stratified by the number of 
minutes spent in MVPA per the accelerometer data in Phase 1 (<21 min/day of MVPA vs. > 21 
min/day of MVPA) with randomly varying block sizes. 
 
Participants are randomized to 1 of 2 arms: the comparison arm, which receives a Fitbit and the 
exercise prescription, or the intervention arm, which also receives a Fitbit and exercise prescription 
PLUS videoconferencing sessions (e.g., FaceTime, Google Hangouts or Skype) with a PA coach (8 
sessions over the course of 20 weeks). Each session lasts approximately 30 minutes and is 
audiotaped. The intervention arm focuses on changing attitudes (e.g., identifying pleasurable 
physical activities), perceptions of social norms of PA (e.g., problem-solving ways to receive support 
from family and friends) and perceptions of control for engaging in PA (e.g., increasing self-efficacy 
through goal setting and reducing barriers), as outlined by the Theory of Planned Behavior, to 
increase time spent in MVPA and decrease SB. The Fitbit is used to facilitate goal setting and self-
monitoring for participants in the intervention arm.  
 
During the course of the study, participants in both arms are asked to participate in an interim 
assessment (between weeks 8-12), which includes 30-45 minutes of questionnaires and wearing an 
accelerometer for 7 days, for which they are compensated $50. Between weeks 20 and 26, 

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participants in both arms are asked to engage in a post-intervention assessment, consisting of 30-
45 minutes of questionnaires, wearing an accelerometer for 7 days, and undergoing a final exercise 
stress test. Caregivers are asked to complete 20-30 minutes of surveys at the post-intervention 
assessment. Adolescents are compensated $100 and caregivers are compensated $20. Parking 
and mileage to/from the hospital is compensated for their final exercise stress test. Upon completion 
of the post-intervention assessment, participants randomized to the intervention arm will be asked 
to participate in focus groups lasting approximately 1.5 hours, to discuss their study experiences. 
There will be 3-4 groups that meet via videoconferencing with 6-8 participants per group. 
Participants who attend the focus group will be compensated $50. Six months after their week 22 
participants will be asked to complete a 6-month follow-up assessment, which consists of 
completing less than one hour of questionnaires and wearing an accelerometer for 7 days, for which 
they will be compensated $75.  
 
Medical information also is collected from participants’ online medical records to consider as 
covariates or moderators of the treatment effect, including sex and indicators of disease status 
(e.g., diagnosis, surgical history, functional class, number of medications, comorbidities, and the 
number of hospitalizations in the past year). 
 
Physical activity coaches are graduate students pursuing advanced degrees in medicine, exercise 
physiology, or other health-related fields. They have undergone over 16 hours of training prior to 
working with the first participant and have completed all required human subjects training.  
 
 

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5 
STUDY ENROLLMENT AND WITHDRAWAL 
The total target sample size for enrollment in Phase 1 is 90 participants and in Phase 2, 70 
participants (35 participants per arm). A higher enrollment is expected for Phase 1 than Phase 2 to 
account for some participants being deemed ineligible to proceed with Phase 2.  
Potential participants are identified through upcoming cardiology clinic rosters who meet the age 
(15-18 years of age) and diagnosis (moderate to complex CHD3) criteria. Study personnel check the 
patient’s medical record to verify eligibility. If a patient appears to be eligible, study staff confirm with 
the attending cardiologist that no additional reason/s preclude the adolescent from participating, 
including limitations to engaging in MVPA. Next, the patient or if the patient is <18 years of age their 
caregiver, is sent a letter from the attending cardiologist, notifying them about the study and that 
study personnel will be in contact. An “opt out” phone number is provided so that the caregiver can 
call and leave a message if they do not wish to be contacted. Approximately 1 week later, if no 
message was received, caregivers are called by study personnel. During the phone conversation, 
the objectives and primary components of the study are discussed. If a patient and caregiver are 
interested, verbal consent/assent (if <18 years of age) is obtained for completing online 
questionnaires and the exercise stress test at NCH is scheduled. During the stress test visit, written 
consent/assent for the stress test and accelerometer assessment is obtained. If a patient and/or a 
caregiver cannot be reached via phone, they are approached during their clinic appointment in 
person. 
5.1 
Participant Inclusion Criteria 
Participants must meet all the inclusion criteria to be eligible to participate in the study. The criteria 
include:  
1) Between 15 and 18 years of age, have not yet graduated from high school OR still living 
with caregivers 
2) Diagnosed with moderate or complex structural CHD  
3) Lives within 120 miles of NCH  
4) Able to complete an exercise stress test on a treadmill 

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5.2 
Participant Exclusion Criteria 
Participants meeting any of the exclusion criteria at baseline will be excluded from the study. These 
criteria include:  
1) Do not speak and write proficiently in English  
2) Have a diagnosis of a genetic syndrome (e.g., Downs, Marfans, Wolf-Parkinson-White)  
3) Have cognitive impairments that would interfere with completion of study measures  
4) Have been engaged in a formal exercise program within the past 6 months, including 
cardiac rehabilitation  
5) Have undergone open-heart surgery or have had a valve replacement in the last 3 months 
6) Are prohibited to engage in MVPA by their cardiologist  
7) Are unable to complete a treadmill-based exercise stress test 
8) Are currently pregnant 
After completing Phase 1, participants are approached for recruitment into Phase 2 unless they 
meet additional exclusion criteria, including:  
9) Having contraindications for exercise based on an exercise stress test (e.g., exercise-
induced arrhythmias or evidence of cardiac ischemia) 
10) Exercising >60 min/day of MVPA per the accelerometer  
11) Do not have internet access or a device for videoconferencing with a PA coach 
 
5.3 
Treatment Assignment Procedures 
5.3.1 Randomization Procedures 
 
The PI, study staff, and the research participant do not know the participant’s arm designation until 
the envelope, which was prepared the by the study statistician (Dr. Rausch) is opened. 

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Randomization is stratified by the number of minutes spent in MVPA per the accelerometer data in 
Phase 1 (<21 min/day of MVPA vs. > 21 min/day of MVPA) with randomly varying block sizes. 
Strata were based on the mean baseline levels of MVPA as reported in 2 studies of adolescents 
with CHD.27,28 
5.3.2 Reasons for Withdrawal 
 
Study participation is discontinued under the following circumstances: 
 
If participant’s cardiologist determines that he/she is no longer eligible for the study due to a 
change in his/her cardiac condition. 
 
The participant or the participant’s legal guardian requests withdrawal from the study. 
 
Development or reveal of any exclusion criteria (e.g., need for cardiac surgery). 
5.3.3 Handling of Withdrawals 
If withdraw occurs because a participant’s cardiologist determines that the participant should no 
longer be in the study due to a change in medical status or the participant and/or caregiver 
request to be withdrawn, participants are asked to complete the assessments if possible and 
are included in intent-to-treat analyses. 
5.3.4 Termination of Study  
Because the AHA and American College of Cardiology indicate that receiving an exercise stress 
test is a standard of care and that CHD survivors with moderate to complex disease should be 
engaged in routine PA as long as it is deemed safe,8 termination of the study due to the 
development of adverse events is not anticipated. There are several procedures aimed to rule out 
any participants who may be at an increased risk of an adverse event due to the intervention. First, 
participants’ cardiologists are asked about the eligibility of each potential participant. Second, 
participants undergo a baseline exercise stress test, in part, to rule out any cardiovascular 
contraindications for PA. If limitations in PA exist, these are incorporated into the exercise 
prescription developed by the exercise physiologist who conducted the stress test/principal 
investigator in consultation with the study physician, and the PA coaches work with participants on 
PA within the parameters of the exercise prescription. Participants’ cardiologists have access to the 
results of the stress test, which are posted in participants’ electronic medical record. However, the 
study will be terminated if the Data Safety Monitoring Board (DSMB) or IRB concludes, based on 
their findings, that termination is in the best interest of the participants.  

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5.4 
Study Intervention Description  
 
During the Phase 2 of the study participants are randomized into the comparison or intervention 
arm. Both the comparison and intervention arm participants receive a Fitbit and are asked to 
complete the interim (between weeks 8-12), post-intervention (between weeks 20-26), and 6-month 
follow-up assessments. In addition, the intervention group is asked to complete 8 videoconferencing 
sessions with a PA coach over 20 weeks (Sessions 1-4 occur weekly; Session 5 is in week 6; 
Session 6 is in week 8; Session 7 is in week 12; Session 8 is in week 20) with each session lasting 
approximately 20-30 minutes. Intervention participants who complete the protocol will also be 
invited to partake in a focus group after the post-intervention assessment has been completed to 
provide feedback on their study experiences. The topics for the intervention sessions focus on 
helping participants to:  
1) Understand the benefits of MVPA, find physical activities they enjoy, and delineate pros 
and cons of engaging in MVPA using a non-judgmental stance (Attitudes) 
2) Trouble-shoot engaging family and friends to be supportive of or engage in PA with the 
participant (Subjective Norms) 
3) Find creative ways to incorporate more MVPA, resolve barriers to PA and promote 
efficacy for engaging in MVPA, and identify intrinsic rewards for accomplishing goals 
(Perceived Control) 
All of the sessions contain a goal-setting component based on the exercise prescription the 
participant obtained from his/her exercise stress test. Participants receive text messages in 
between sessions, which contain motivational or encouraging content. 
5.5 
Modification of Study Intervention 
Modifications to the study intervention may occur if a participant experiences a change in their 
cardiac health during the course of the study and his/her cardiologist recommends an alteration in 
the participant’s exercise prescription.  
5.6 
Accountability Procedures for the Study Intervention  
Individual and group supervision sessions are held for coaches to clarify study procedures, receive 
feedback on interactions with participants, and share ideas for ways to trouble-shoot around 
barriers to PA that participants broach during session. Dr. Vannatta, who is familiar with the study 
but is not directly involved, as well as another study staff member, will listen to a random selection 
of 2 audiotaped sessions per participant and rated on their fidelity. Fidelity <90% triggers retraining 
of the interventionist as to the study materials.  

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5.7 
Assessment of Subject Compliance with Study Intervention 
Participant compliance in the intervention arm is monitored in two ways. First, participants are 
asked to wear a Fitbit, which is used by the coaches to assess the participants’ engagement in 
MVPA. Coaches request that participants in the intervention arm sync their Fitbit each day so that 
coaches may monitor their PA levels and incorporate feedback during sessions. Participants’ 
attendance at each session is documented. For those participants in the comparison arm, they are 
told to sync their Fitbit regularly upon first receiving the Fitbit, but are not contacted about the Fitbit 
again.  
5.8 
Concomitant Treatments 
Given the primary and secondary outcomes of the study, participants who are currently or have 
engaged in a formal exercise program in the past 6 months, including cardiac rehabilitation, are not 
able to participate in the study. Engaging in sports during the study is not an exclusionary criterion.  
   

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6 
STUDY SCHEDULE, STUDY PROCEDURES/ 
EVALUATIONS 
6.1 
Screening 
Potential participants are identified through scheduled clinic appointments for the upcoming 
month. Study personnel first identify patients who meet the age criteria and then check the 
patient’s medical record to verify their eligibility based on the inclusion and exclusion criteria.  If 
a patient appears to be eligible the cardiologist confirms that they do not know of any reason the 
patient should not participate in this research, including limitations to engaging in MVPA. The 
patient and/or their caregiver(s) (or their legal guardian of record), if an adolescent, is then sent 
a letter from the attending cardiologist, notifying them about the study and that study personnel 
will be in contact.  
6.2 
Phase 1: Enrollment/Baseline (T1) 
 
Once the participant, and the caregiver have consented/assented, they are asked to complete an 
online questionnaire. The participant is also asked to undergo an exercise stress test and wear an 
accelerometer for 7 days. The stress test is completed at NCH within 3-4 weeks of recruitment and 
standardized feedback will be provided by an exercise physiologist, which includes their VO2max. 
Once completed, participants are compensated $100 for their time for the baseline assessment. 
 
Baseline online questionnaire:  
Socio-demographics characteristics (participant & caregiver, if applicable) 
Benefits of PA50 (participant) 
Subjective Norms survey51 (participant & caregiver, if applicable) 
Social Support for Exercise survey52,54 (participant) 
Barriers to Exercise survey53 (participant) 
Self-Efficacy for Exercise Scale54 (participant) 
Patient-Reported Outcomes Measurement Information System45-47 (participant & caregiver, 
if applicable) 
International Physical Activity Questionnaire48,49 (participant & caregiver, if applicable) 
Cardiac Anxiety Questionnaire55 (participant) 
Modified Body Image Disturbance Questionnaire56 (participant) 
Physical Activity Stages of Change Questionnaire – Algorithm (participant)59 

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Physical Activity Stages of Change Questionnaire – Continuous (participant)60-62 
Family Environment Scale58 (caregiver, if applicable) 
Child Vulnerability Scale57 (caregiver, if applicable) 
 
VO2max: VO2 measurement is obtained via a graded exercise stress test on a treadmill. Exercise 
stress test results are used by the exercise physiologist to devise an exercise prescription that 
consists of recommendations for frequency, duration, intensity and type of PA. Exercise 
prescriptions are provided to participants if they qualify and enroll in Phase 2. Participants who are 
found to have an arrhythmia or show evidence of cardiac ischemia during exercise stress testing 
are immediately referred to their cardiologist for follow-up and are not be eligible for Phase 2. 
 
MVPA and SB: Participants receive a triaxial accelerometer (ActiGraph, model wGT3X-BT), 
sensitive to movement in all directional planes, to measure the amount of time spent in sedentary, 
light, moderate, and vigorous PA. The accelerometer is worn around the waist for 7 days for at least 
10 hours per day, only to be removed when showering or submerging in water (e.g., swimming). 
Participants will also complete self-monitoring PA logs in the case they cannot wear the 
accelerometer (e.g. swimming). If baseline accelerometer and self-monitor PA log data indicate that 
a participant averages at least 60 minutes of MVPA per day, they are not eligible for Phase 2. 
 
Compensation: Caregivers are compensated $20 after they complete the baseline surveys. 
Participants are compensated $100 for completing the baseline survey, exercise stress test, and 
wearing the accelerometer for at least 4 days (1 weekend day, 3 weekdays), for at least 10 hours 
per day. Additionally, participants’ parking and mileage to/from the hospital for the exercise stress 
test are reimbursed. 
 
Contact and Scheduling. If the participant is eligible for the Phase 2, they are contacted by phone 
and asked to schedule a home visit, within 8 weeks from their exercise stress test, if interested in 
participating. 
6.3 
Phase 2: Enrollment in the RCT  
 
Eligible participants from Phase 1 are met at their home (or the hospital if preferred) to receive their 
Fitbit and exercise prescription, which is based on the results of their stress test. After receiving the 
Fitbit and exercise prescription, the participant’s arm designation is revealed by opening an 
envelope that has been prepared by the study statistician, Dr. Rausch. Prior to opening the envelop, 
the study PI, study staff, and the participant are blind to the study arm designation. 

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6.4 
Interim Assessment (between weeks 8-12) 
 
Participants in both arms are asked to complete an interim assessment (between weeks 8-12), 
which includes: 
 
Interim online questionnaire: Participants are asked to complete the same questionnaire that was 
completed at Baseline, with the exception of those in the comparison arm receiving questions about 
changes to their health since Baseline. 
Benefits of PA50  
Subjective Norms survey51  
Social Support for Exercise survey52  
Barriers to Exercise survey53  
Self-Efficacy for Exercise Scale54  
Patient-Reported Outcomes Measurement Information System45-47  
International Physical Activity Questionnaire48,49  
Cardiac Anxiety Questionnaire55  
Changes in Health 
Physical Activity Stages of Change Questionnaire – Algorithm (participant)59 
Physical Activity Stages of Change Questionnaire – Continuous (participant)60-62 
 
MVPA and SB: Participants wear an accelerometer again for the same period (7 days) as the 
Baseline assessment and complete self-monitoring PA logs in the case they cannot wear the 
accelerometer (e.g. swimming).  
 
Compensation: Participants are compensated $50 for completion of the interim assessment survey 
and wearing the accelerometer for at least 4 days (1 weekend day, 3 weekdays), for at least 10 
hours per day. 
6.5 
Post-Intervention (between weeks 20-26) 
 
Participants in both arms are asked to complete a post-intervention assessment (between weeks 
20-26), which includes: 
 
Post-intervention online questionnaire: Similar items are included on the post-intervention 
questionnaire as with the baseline and interim assessment with the exception that participants and 
their caregivers, if applicable, are asked to rate the intervention on multiple dimensions.   
Benefits of PA50 (participant) 

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Subjective Norms survey51 (participant & caregiver, if applicable) 
Social Support for Exercise survey52 (participant) 
Barriers to Exercise survey53 (participant) 
Self-Efficacy for Exercise Scale54 (participant) 
Patient-Reported Outcomes Measurement Information System45-47 (participant & caregiver, 
if applicable) 
International Physical Activity Questionnaire48,49 (participant & caregiver, if applicable) 
Cardiac Anxiety Questionnaire55 (participant) 
Family Environment Scale58 (caregiver, if applicable) 
Child Vulnerability Scale57 (caregiver, if applicable) 
Changes in Health (participant) 
Physical Activity Stages of Change Questionnaire – Algorithm (participant)59 
Physical Activity Stages of Change Questionnaire – Continuous (participant)60-62 
Post-Intervention Satisfaction (participant & caregiver, if applicable) 
 
MVPA and SB: Participants wear an accelerometer again for the same measurement period (7 
days) as in previous assessments and complete self-monitoring PA logs in the case they cannot 
wear the accelerometer (e.g. swimming). 
 
VO2max: VO2 measurement is obtained again with a graded exercise stress test using a modified 
Bruce protocol. Participants who were found to have an arrhythmia or show evidence of cardiac 
ischemia during exercise stress testing will be immediately referred to their cardiologist for follow-
up. 
 
Compensation: Caregivers are compensated $20 during the exercise stress test visit after they 
complete the post-intervention surveys. Participants are compensated $100 for completion of the 
post-intervention survey, exercise stress test, and returning the accelerometer with at least 4 days 
(1 weekend day, 3 weekdays), for at least 10 hours per day of data. Additionally, participants 
parking and mileage to/from the hospital for the exercise stress test are reimbursed. 
6.6 
Focus Groups (after post-intervention assessment) 
 
Participants in the intervention arm are asked to partake in a focus group lasting approximately 1.5 
hours, to discuss their experiences in the study. There will be 3-4 groups that meet via 
videoconferencing with 6-8 participants per group. 
 
Compensation: Participants are compensated $50 for being in the focus group. 

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6.7 
6-Month Follow-up (between weeks 46-50) 
 
Participants in both arms are asked to complete a 6-month follow-up assessment (between weeks 
46-50), which includes: 
 
6-month follow-up online questionnaire: Participants are asked to complete the same questionnaire 
that was completed at the interim assessment. 
Benefits of PA50  
Subjective Norms survey51  
Social Support for Exercise survey52  
Barriers to Exercise survey53  
Self-Efficacy for Exercise Scale54  
Patient-Reported Outcomes Measurement Information System45-47  
International Physical Activity Questionnaire48,49  
Cardiac Anxiety Questionnaire55  
Changes in Health 
Physical Activity Stages of Change Questionnaire – Algorithm59 
Physical Activity Stages of Change Questionnaire – Continuous60-62 
 
MVPA and SB: Participants wear an accelerometer again for the same measurement period (7 
days) as in previous assessments and complete self-monitoring PA logs in the case they cannot 
wear the accelerometer (e.g. swimming). 
 
Compensation: Participants are compensated $75 for completion of the 6-month follow-up 
assessment survey and wearing the accelerometer for at least 4 days (1 weekend day, 3 
weekdays), for at least 10 hours per day. 
 
6.8 
Additional Incentive 
In addition to the compensation described in sections 6.2, 6.4, and 6.5, participants in both arms 
are able to keep the Fitbit.  

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7 
ASSESSMENT OF SAFETY 
7.1 
Methods and Timing for Assessing, Recording, and Analyzing 
Safety Parameters 
7.1.1 Adverse Events 
Definition 
For the current study, an adverse event is an unanticipated change in cardiovascular, 
musculoskeletal, or emotional symptoms that are (1) concerning to the participant and (2) 
results in seeking medical attention, if cardiovascular or musculoskeletal in nature. Any 
condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an adverse event. However, if the study participant’s condition 
deteriorates at any time during the study, it will be recorded as an adverse event. Serious 
adverse events are defined as adverse events that are severe in classification (as described 
below). We do not anticipate any serious adverse events due to study procedures. Adverse 
events that occur for participants during the course of the study are comprehensively 
documented, including events during the stress test, symptoms reported during the course of 
the intervention from participants in the intervention arm, dates and reasons for pauses in the 
study protocol due to symptom reporting, and determination of ability to proceed by participants’ 
cardiologists. All unscheduled cardiology outpatient visits, visits to urgent care or the emergency 
department, unscheduled hospitalizations, or any other changes in health are documented. 
Participants in the comparison arm are asked whether they sought medical attention in the 
aforementioned contexts during the interim and post-intervention questionnaires. Additionally, 
the occurrence of any adverse event or serious adverse event may come to the attention of 
study staff during other study contacts (e.g., intervention meetings). 
 
Classification  
All adverse events and serious adverse events will be assessed by the PI and the study physician, 
Dr. Clifford Cua, according to the guidelines outlined here.  
 
Severity: The following guidelines will be used to describe severity: 
 
Mild: Events require minimal or no treatment and do not interfere with the participant’s daily 
activities. 

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 
Moderate: Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
 
Severe: Events that require in-patient hospitalization and/or resulted in death or permanent 
disability.  
 
Relationship to Study Intervention: The degree of certainty about causality will be graded using the 
categories below. 
 
Related: The adverse event is known to occur with the study procedures, there is a 
reasonable possibility that the study procedures caused the adverse event, or there is a 
temporal relationship between the study procedures and the adverse event. Reasonable 
possibility means that there is evidence to suggest a causal relationship between the study 
procedures and the adverse event.  
 
Not Related: There is not a reasonable possibility that the study procedures caused the 
adverse event, there is no temporal relationship between the study procedures and adverse 
event onset, or an alternate etiology has been established. 
 
Expectedness: It is determined whether an adverse event is expected or unexpected, according to 
the following criteria. 
 Expected: Adverse event is consistent with the risk information previously described for the 
study procedures. 
 Unexpected: Adverse event is not consistent with the risk information previously described 
for the study procedures. 
Safety Procedures 
The current study has several procedures in place to reduce the likelihood of serious adverse 
events. Potential participants’ cardiologists are notified prior to being recruited for the study and 
excluded if the cardiologist has communicated or documented any concerns about that adolescent 
engaging in MVPA. All participants undergo a baseline exercise stress test and are not approached 
for recruitment for Phase 2 if contraindications are detected in Phase 1. In the rare event that a 
participant has an acute medical event during the exercise stress test, appropriate hospital 
procedures are enacted, which include calling an emergency response team and immediate 
evaluation by a cardiologist. The same procedures used for patients undergoing exercise stress 
testing as part of a medical evaluation are initiated and followed. During the course of the 
intervention, if an adolescent reports cardiac symptoms that are concerning to the participant and 
are new since the last cardiac evaluation, PA coaches are trained to request that the adolescent tell 
his/her caregiver (if they haven’t already done so) and contact their cardiologist. Adolescents and 
their caregiver have given the study PI, Dr. Jackson, permission to talk with the cardiologist in the 
instance that a concerning and/or new cardiac symptom is reported. All study procedures are put on 
hold until the adolescent is evaluated by the cardiologist and cleared to proceed with the study.   
If a participant was to report bothersome emotional symptoms to study staff during the course of the 
study, Dr. Jackson, a licensed psychologist, will contact the participant to evaluate the severity of 

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their emotional symptoms. If the participant is not in danger of harming themselves or someone 
else, Dr. Jackson will assist the participant in identifying mental health resources. If the participant is 
positive for significant suicidal or homicidal ideation (i.e., positive for intent, has a plan, and has the 
means by which to execute a plan), Dr. Jackson will notify the participant that confidentiality must 
be broken and the local authorities will be contacted.   
7.1.2 Procedures to be Followed in the Event of Abnormal Test Values or 
Abnormal Clinical Findings 
Incidental findings from the exercise stress test are communicated to the participant and caregiver, 
if applicable, and the participant’s cardiologist. The cardiologist will make a determination as to 
whether the participant may proceed with the study if an abnormal event, or incidental finding, is 
detected.  
7.1.1 Other Medical Events 
Medical events not meeting the above definition of an adverse event.  
7.1.2 Unanticipated Problems 
In line with the OHRP definition, unanticipated problems include any incident, experience, or 
outcome that meets all of the following criteria: 
1. unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are 
described in the protocol-related documents, such as the IRB-approved research protocol and 
informed consent document; and (b) the characteristics of the subject population being studied; 
2. related or possibly related to participation in the research (in this guidance document, possibly 
related means there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); and 
3. suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
 
 

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7.2 
Reporting Procedures 
7.2.1 Adverse Events 
Any adverse events are reported to the DSMB at each meeting and to the NCH IRB annually. 
7.2.1 Serious Adverse Events 
 
The DSMB is notified of any serious adverse events determined to be related to the intervention 
and are unexpected within 5 business days of discovery. Other serious adverse events are 
reported to the DSMB at each meeting. 
 
Similarly, and per the NCH HRP-103 (updated 12/10/2018), serious adverse events determined 
to be related to the intervention and are unexpected are reported to the NCH IRB within 5 
business days of discovery. Other serious adverse events are reported to the NCH IRB 
annually. 
 
Serious adverse events that are fatal or life-threatening and are unexpected are reported to 
NHLBI within 7 calendar days of discovery by the investigator. For non-fatal, non-life-threatening 
unexpected, serious adverse events, NHLBI is notified within 15 calendar days, by the 
investigator.  
7.2.2 Unanticipated Problems 
 
Any unanticipated problems that are not serious adverse events will be reported to the DSMB within 
2 weeks and to NHLBI within 14 days by the investigator. If an unanticipated event is considered a 
serious adverse event, the aforementioned reporting time for serious adverse events will be 
followed. 
 
7.3 
Type and Duration of Follow-up of Subjects after Adverse Events 
Participants will be monitored for adverse events and unanticipated problems from the start of the 
intervention in Phase 2 until the post-intervention assessment that occurs 22 weeks after the start of 
the intervention, as this signifies study completion. Adverse events and unanticipated problems will 

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be followed until stabilization or resolution, or 30 days after study completion (whichever occurs 
sooner). 
All cardiac-related adverse events and unanticipated problems are discussed with the cardiology 
medical team. The cardiology medical team determines whether participation in the study is 
suspended, and for how long, or terminated.  
7.4 
Halting Rules 
If it is found that the study intervention is related to any serious adverse events, enrollment will be 
temporarily suspended until a safety review is convened. The DSMB will decided whether the study 
should continue per protocol, proceed with caution, be further investigated, be discontinued, or be 
modified and then proceed. Suspension of enrollment (for a particular group or for the entire study) 
is another potential outcome of a safety review. 
7.5 
Safety Oversight 
 
Safety oversight of this study is under the direction of the study PI, NCH IRB, as well as a 
DSMB. The DSMB consists of two faculty members from NCH and a faculty member from the 
University of Notre Dame. Dr. May Ling Mah is a dual-boarded pediatric and adult congenital 
cardiologist housed in the Heart Center at NCH. Dr. Mark Klebanoff is a board-certified 
pediatrician and a former Director of the Division of Epidemiology, Statistics, and Prevention 
Research at the National Institute of Child Health and Human Development. Dr. Klebanoff has 
been involved as a Co-I of multiple RCTs and currently serves on the DSMB for an NIH-funded 
clinical trial. Dr. Ken Kelley is a Professor in the Department of Psychology, an Associate Dean 
for Faculty and Research in the Mendoza College of Business at the University of Notre Dame, 
and is an accredited professional statistician per the American Statistical Association. Dr. Kelley 
currently serves on several DSMBs for NIH-funded clinical trials. The NCH IRB has reviewed 
and approved the Data and Safety Monitoring Plan for this study. Bi-yearly reports summarizing 
the number of participants enrolled, the number of stress tests completed, the number of 
abnormalities detected during exercise stress testing, adverse events and serious adverse 
events, and the number of participants who have contacted their cardiologists due to concern 
over symptoms while engaged in the treatment arm will be provided to the DSMB. This 
summary is submitted to the IRB with the annual review.  
7.6 
Study Hypotheses 
 

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Hypothesis 1: Participants are hypothesized to rate the intervention as not burdensome, easy to 
access, and appealing. Additionally, recruitment and retention rates are predicted to be >75%. 
 
Hypothesis 2: Participants in the treatment arm will (A) increase MVPA relative to those in the 
comparison arm at post-intervention, (B) decrease SB relative to those in the comparison arm, 
and (C) demonstrate an increase in VO2max at post-intervention relative to those in the 
comparison arm.   
7.7 
Sample Size Considerations 
A sample size of n=35 per group will provide 80% power to detect a large effect size63 for the 
standardized mean difference, still allowing for possible detection of a medium effect size (d=.6) 
with 55% power. Effect sizes from relevant studies examining change in MVPA range from large 
(d=.94; CHD adolescents in a motivational interviewing-style exercise intervention)28 to small 
(d=.17; older adults with cardiovascular risk factors).22 Thus, our primary goal is to estimate an 
initial effect size for our intervention in our population, with a secondary goal to detect large 
effect sizes that may exist for study outcomes. However, effect estimation with a relatively small 
sample size should be interpreted with caution, as it may under or overestimate the sample 
size.64,65 
7.8 
Planned Interim Analyses (if applicable) 
No interim analysis is planned.  
7.9 
Analysis Plan 
 
Aim 1: Evaluate the feasibility of the intervention.  
 
The mean/median ratings by participants on multiple dimensions of the intervention will be 
computed. Recruitment rate will be calculated as a percentage of those recruited out of those 
approached. Percent adherence across sessions will be calculated for those in the intervention 
arm as the number of sessions attended out of 8. The retention rate will be identified by dividing 
the number of participants who do not complete the study by the number of participants 
enrolled.   
 
Verbal responses collected during the focus groups will be transcribed and then coded so that 
the frequencies of suggestions can be calculated. 
 
Aim 2: Examine preliminary efficacy of the intervention on time spent in MVPA.  
 
First, independent sample t-tests (continuous variables) or chi-square tests (categorical 
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considerations such as sex and disease status, to determine if statistically significant differences 
are present. Only the pre-specified covariates of baseline minutes spent in MVPA and baseline 
VO2max will be included in the primary analyses.66 However, if statistically significant differences 
are found at baseline, those variables will be examined as covariates in all statistical models of 
interest in an exploratory fashion.  
 
Second, the following statistical model for repeated measures (RM), based on maximum 
likelihood estimation, will be employed,67 yit =  β0 + β1Timet + β2Timet xTrti + εit, where implicitly it 
is assumed that there is no main effect of Trti, yit is minutes in MVPA at time t, Timet is coded as 
0 for baseline and 1 for post-intervention, and the primary effect of interest is β2, which is the 
difference between groups on participants’ minutes in MVPA. In this RM model, baseline levels 
of minutes in MVPA is constrained to have equal means across groups by assuming there is no 
main effect of the intervention, Trti. This constraint yields a statistical test for β2 analogous to the 
test of the treatment group main effect per ANCOVA without requiring list-wise deletion to 
account for missing data. A similar strategy will be taken for analyzing change in SB and VO2max 
as secondary outcomes.    
 
Aim 3: Explore mechanisms of change in MVPA and SB, as specified by the Theory of 
Planned Behavior, including attitudes (i.e., knowledge about and belief in positive 
outcomes from PA), normative beliefs (i.e., participant-report of family/friend/physician 
beliefs about and support of PA) and perceived behavioral control (i.e., barriers and 
efficacy for PA).  
 
Differences between intervention and comparison arm participants on attitudes, normative 
beliefs and perceived control at the interim assessment will be examined using independent 
sample t-tests. These variables then will be included in longitudinal mediation models exploring 
the indirect effects of the intervention on change in behavior as compared to the comparison 
group on MVPA and SB via the identified mechanisms at the interim assessment. We will use 
Mplus, which employs bootstrapping to statistically test mediators of the pathway of interest, 
both individually and simultaneously, to estimate whether one accounts for more variance in the 
treatment effect relative to another. We will follow guidelines for testing longitudinal mediation 
within Cole & Maxwell67 and MacKinnon.68 We acknowledge that due to the limited sample size, 
significant mediation may not be detectable. However, indirect paths nearing significance will 
have important implications for the future refinement of the intervention by allowing us to focus 
on the most salient mechanisms of behavior change for the R01 application. Significant Pearson 
correlations between baseline levels of proposed mechanisms of change and MVPA and SB 
may also be informative for adjusting the intervention prior to the R01 application to more 
directly address these factors. Sex will be explored as a potential moderator of intervention 
effects.   
 
Other Analyses: Relationships between other predictors and study outcomes will also be explored. 
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examined as possible predictors of participants’ willingness to participate in Phase 2 of the study, as 
well as change in the study outcome variables using linear regression. 

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8 
SOURCE DOCUMENTS AND ACCESS TO SOURCE 
DATA/DOCUMENTS 
All study related records are kept in compliance with the regulatory and institutional requirements of 
confidentiality of subjects. Examples of these original documents and data records include, but are 
not limited to: hospital records and recorded data from surveys, accelerometers, Fitbits, 
videoconferencing sessions, and focus groups. Also, only authorized study personnel and NCH IRB 
staff have access to the records, all of whom have received training on the responsible conduct of 
human subject research. 

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9 
QUALITY CONTROL AND QUALITY ASSURANCE 
The quality management program for this study consist of a system of quality checks on all data 
collection procedures, in addition to a system of training. 
All study personnel working with data or protected health information have been properly trained, 
including completing the online CITI certification and undergoing a day-long instructional seminar at 
the hospital for protecting human subjects and engaging in best practices for responsible conduct of 
research. Furthermore, PA coaches have undergone over 16 hours of training prior to working with 
the first participant and have completed all required human subjects training. 
At periodic intervals, the quality of the videoconferencing sessions will be evaluated by Dr. Vannatta 
and another research staff member. They will listen to two randomly selected sessions for each 
participant. These evaluations will consist of completing a fidelity checklist to evaluate 
compliance/adherence to the session protocol. 

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10 
ETHICS/PROTECTION OF HUMAN SUBJECTS 
10.1 Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with the principles set forth 
in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of 
Research of the US National Commission for the Protection of Human Subjects of Biomedical and 
Behavioral Research (April 18, 1979) and codified in 45 CFR Part 46 and/or the ICH E6; 62 Federal 
Regulations 25691 (1997).  
10.2 Institutional Review Board 
The NCH IRB has reviewed and approved the protocol for this study, including all associated 
documents such as the informed consent/assent, surveys, and work sheets for the 
videoconferences. Study amendments will be approved by the NCH IRB prior to implementing any 
edits to the study protocol or associated documents. 
10.3 Informed Consent Process 
Potential participants are identified through a list of all patients who meet the age and diagnosis 
criteria. Once the list has been generated, study personnel check the patient’s medical record, as 
well as contact the patient’s cardiologist, to verify their eligibility. If a patient appears to be eligible, 
the patient and/or caregiver(s) (or their legal guardian of record) are sent a letter from the attending 
cardiologist, notifying them about the study and that study personnel will be in contact. An “opt out” 
phone number on the letter is provided so that the caregiver(s) can call and leave a message if they 
do not wish to be contacted. Approximately 1 week later, if no message was received, the patient 
and/or caregiver(s) are called by study personnel. During the phone conversation, the objectives 
and primary components of the study are discussed. Also, potential participants are reminded of 
their rights as a participant, including that nonparticipation will not impact their care at NCH. If the 
patient and caregiver, if applicable, are interested, verbal consent/assent is obtained for completing 
the online questionnaires and the exercise stress test is scheduled. During the stress test, written 
consent for using the accelerometer and undergoing the stress test is obtained from participants 
and/or caregivers and written assent is obtained from adolescent participants. Participants retain a 
copy of consent/assent forms for their own records. 

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10.3.1 Informed Consent/Assent Process (in Case of a Minor) 
 
For participants under the age of 18, both verbal consent from a caregiver and verbal assent from 
the adolescent is obtained for completing the online questionnaire. Written consent and assent is 
then obtained for wearing the accelerometer and undergoing the exercise stress test at the exercise 
stress test visit, thereby completing the Phase 1 consent/assent process. Similarly, written consent 
from a participant or caregiver, and written assent if a participant is <18 years of age is obtained to 
participate in Phase 2 of the study. 
10.4 Subject Confidentiality 
Subject confidentiality is strictly held by the PI, study personnel, as well as the sponsor(s) and their 
agents. The study protocol, data, and all other information generated is held in strict confidence. No 
information concerning the study or the data will be released to any unauthorized third party. 
A study monitor or other authorized representatives may inspect all documents and records 
maintained. Records will be retained until it has been determined that those participants would not 
be contacted for follow-up or other relevant studies. 
10.5 Study Discontinuation 
If the DSMB were to determine that the study procedures were producing more harm than good for 
participants, the study would be discontinued. 

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11 
DATA HANDLING AND RECORD KEEPING 
11.1 Data Management Responsibilities 
The PI is responsible for ensuring the accuracy, completeness, legibility (if applicable), and 
timeliness of the data reported. All study data is reviewed by the study personnel, who ensure that 
the obtained information is accurate and complete. 
Additionally, study personnel are responsible for the data management, quality review, analysis, 
and reporting of the study data under the direction of the PI. 
11.2 Data Capture Methods 
For the purposes of this study, data is captured via paper and/or electronic methods. The only link 
between the participants’ name and ID is an electronic tracking sheet, which is stored on the 
password protected hospital network and hospital OneDrive. All questionnaire data is stored in 
REDCap, a secure web application for building and managing online surveys and databases. Fitbit 
data is stored in Fitabase, a comprehensive online data management platform. Accelerometer data, 
along with the exported questionnaire, Fitbit data, and audio recordings of the focus groups are 
stored in the hospital’s secured research network. The audio recordings of the videoconferencing 
sessions are housed in the hospital’s secure OneDrive. All other data is kept in a locket cabinet 
within a locked office at NCH and only direct study personnel have access to this information. 
Also, study personnel will conduct internal quality checks, such as automatic range checks, to 
identify data that appear inconsistent, incomplete, or inaccurate. 

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11.3 Types of Data 
Data for this study include questionnaires (electronic or pen and paper), medical record, audio 
recordings, and other forms of electronic data from accelerometers, Fitbits, sessions, and the 
exercise stress tests. 
11.4 Study Records Retention 
Study records are kept on the hospital’s secured research network and OneDrive until it has been 
determined that those participants would not be contacted for follow-up or other relevant studies. 
11.5 Protocol Deviations 
A protocol deviation is any noncompliance with the clinical trial protocol, Good Clinical Practice, or 
Manual of Procedures requirements. The noncompliance may be either on the part of the subject, 
the investigator, or the study personnel. As a result of deviations, corrective actions are to be 
implemented promptly. 
All deviations from the protocol must be addressed in study source documents and are 
documented. Protocol deviations are sent to the IRB per their guidelines. 

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12 
PUBLICATION POLICY 
 
Following completion of the study, the PI anticipates publishing the results of this research in a 
scientific journal.  The International Committee of Medical Journal Editors (ICMJE) member journals 
have adopted a trials-registration policy as a condition for publication. This policy requires that all 
clinical trials be registered in a public trials registry such as ClinicalTrials.gov*, which is sponsored 
by the National Library of Medicine. 

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13    PROTECTED HEALTH INFORMATION RECORDING 
 
 
1.0 
Indicate which subject identifiers will be recorded for this research. 
☒  Name 
☒  Complete Address 
☒  Telephone or Fax Number 
☐  Social Security Number (do not check if only used for ClinCard) 
☒  Dates (treatment dates, birth date, date of death) 
☒  Email address , IP address or url 
☒  Medical Record Number or other account number 
☐  Health Plan Beneficiary Identification Number 
☐  Full face photographic images and/or any comparable images (x-rays) 
☐  Account Numbers 
☐  Certificate/License Numbers 
☐  Vehicle Identifiers and Serial Numbers (e.g. VINs, License Plate Numbers) 
☐  Device Identifiers and Serial Numbers 
☒  Biometric identifiers, including finger and voice prints 
☐  Other number, characteristic or code that could be used to identify an individual 
☐  None (Complete De-identification Certification Form) 
 
2.0   
Check the appropriate category and attach the required form* on the Local Site 
Documents, #3. Other Documents, page of the application.  (Choose one.) 
☒  Patient Authorization will be obtained.  
☒  Protocol meets the criteria for waiver of authorization. 
☐  Protocol is using de-identified information.  
☐  Protocol involves research on decedents.  
☐  Protocol is using a limited data set and data use agreement.  
 
 
3.0 
How long will identifying information on each participant be maintained? 
 
Identifying information will be maintained on each participant until it has been 
determined that those participants would be contacted for follow-up or other relevant 
studies.  
 
For potential participants who declined participation, identifying information will be 
maintained until the main study results have been published after peer review.  
 
4.0 
Describe any plans to code identifiable information collected about each 
participant. 
 
Participants will be assigned a study ID number, which will be used on all questionnaire 
(paper or online) and accelerometer data (including data from the Fitbit). The only link 
between the participant’s name and ID will be an electronic tracking sheet, which will be 

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stored on the password protected hospital network and hospital OneDrive. Online 
questionnaire data and digital recordings of videoconferencing sessions will be housed 
behind a secure firewall on the password protected NCH research internet server. All 
other data will be kept in a locked cabinet within a locked office at NCH and only direct 
study personnel will have access to this information. All study personnel who will be 
working with data or protected health information will be properly trained, which includes 
completing the online Collaborative Institutional Training Initiative certification and 
undergoing a day-long instructional seminar at the hospital for protecting human 
subjects and engaging in best practices for responsible conduct of research. 
 
During videoconferencing, coaches will conduct sessions in privacy and will encourage 
participants to do the same. Coaches will undergo the same training as other research 
staff at NCH, including completing CITI certification and a day-long instructional seminar 
on protecting human subjects. Videoconferencing has a lower risk of privacy breach than 
email communications. 
 
5.0 
Check each box that describes steps that will be taken to safeguard the 
confidentiality of information collected for this research: 
☒ Research records will be stored in a locked cabinet in a secure location 
☒ Research records will be stored in a password-protected computer file 
☒ The list linking the assigned code number to the individual subject will be maintained 
separately from the other research data 
☒ Only certified research personnel will be given access to identifiable subject 
information 
 
6.0 
Describe the provisions included in the protocol to protect the privacy interests     
      of subjects, where "privacy interests" refer to the interest of individuals in being     
      left alone, limiting access to them, and limiting access to their information. (This    
            is not the same provision to maintain the confidentiality of data.) 
 
 
 
When potential participants are first notified about the study via a letter from their  
cardiologist or the research team, there will be an opt out number provided. This will 
allow participants to notify the study team if they are not interested in being approached. 
 
 
During the consent process, participants will be told about what information will be  
            collected and that they can withdraw permission for study staff to access that information 
            at any time. 
 
           For those who decline participation, they will no longer be contacted by study staff. 
           Information will be gleaned from their medical charts around the time of decline and 
           would not be accessed again unless clarification of the data collected is needed. 
 
Confidential Health Information 
 
1.0 
Please mark all categories that reflect the nature of health information to be 
accessed and used as part of this research. 
 
☒  Demographics (age, gender, educational level) 

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☒  Diagnosis 
☒  Laboratory reports 
☐  Radiology reports 
☐  Discharge summaries 
☒  Procedures/Treatments received 
☒  Dates related to course of treatment (admission, surgery, discharge) 
☐  Billing information 
☒  Names of drugs and/or devices used as part of treatment 
☒  Location of treatment 
☒  Name of treatment provider 
☒  Surgical reports 
☐  Other information related to course of treatment 
☐  None 
 
2.0 
Please discuss why it is necessary to access and review the health information 
noted in your response above. 
 
Confidential health information will be accessed and reviewed in order to determine 
eligibility, determine disease severity, and described the clinical characteristics of the 
sample. Disease severity and other medical information may be used as a covariate in 
the analyses.  
 
Confidential heath information will also be accessed and reviewed to determine whether 
those who decline participation vary significantly in disease severity, athletic 
involvement, or distance form NCH. Ultimately, this information will be used to alter 
future iterations of the intervention.   
 
3.0 
Is the health information to be accessed and reviewed the minimal necessary to 
achieve the goals of this research?  ☒ Yes    ☐ No 
 
4.0 
Will it be necessary to record information of a sensitive nature?  ☐ Yes   ☒ No 
 
5.0 
Do you plan to obtain a federally-issued Certificate of Confidentiality as a means 
of protecting the confidentiality of the information collected?  ☒ Yes   ☐ No 
 
This study is funded by the National Institutes of Health and is therefore automatically 
issued a Certificate of Confidentiality.  
 

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14  TEMPORARY CHANGES IN PROTCOL IN RESPONSE TO 
        THE COVID-19 PANDEMIC 
 
Pursuant to the communications “Research Continuity During the COVID-19 Pandemic #1” 
(3/13/2020) and “Research Continuity During the COVID-19 Pandemic #2 (3/16/2020), and in 
order to eliminate potential hazard to research participants, the CHD-PALS will enact the 
following procedures, effective 3/13/2020: 
 
Scheduled in-person home visits will be canceled and will instead be conducted 
remotely via videoconferencing (e.g., Google Hangouts). The IRB has previously 
approved the use of videoconferencing for the delivery of lifestyle interventions in this 
study. Videoconferencing has been reviewed by the NCH security team and was 
determined to have a lower risk of privacy breach than email communications. In-person 
home visits will resume when determined safe by NCH. 
 
Study materials necessary to complete the virtual home visit (e.g., consent forms, FitBit, 
lifestyle intervention sessions notes) will be sent to participants via postal mail or e-mail 
in advance of the visit. Study staff will confirm participant’s mailing address prior to 
sending materials via postal mail. Materials sent via postal mail will be issued tracking 
numbers, and study staff will monitor the status of these materials.  
 
Participants will provide written informed consent during the virtual home visit. As noted 
above, consent forms will be mailed to participants prior to the virtual home visit. Study 
staff will review the consent forms with participants via videoconferencing and will ask 
participants to sign the consent form (if deciding to participate) during the virtual home 
visit. Study staff will request that participants show their signature on the consent form to 
obtain visual confirmation of written informed consent. Study staff will document the date 

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and time that written informed consent is obtained during the virtual home visit. 
Participants will be provided with a self-addressed, postage paid envelope to return the 
consent form to the research office. Study staff conducting the virtual home visit and 
obtaining informed consent will sign and date the consent form upon return to the 
research office. Participants will also have the option of scanning their consent form and 
submitting it via email.  
 
According to our protocol, home visits are intended to be completed within 8 weeks of 
the baseline stress test. We will allow participants to enroll in Phase 2 of the study if their 
home visit (in-person or virtual) must be completed outside of this window. 
 
Scheduled exercise stress tests conducted at the outpatient cardiology clinic will be 
canceled until 5/30/2020. Stress tests will be rescheduled when it has been determined 
to safe to resume in-person research activities. As a result, we will permit participants to 
complete exercise stress tests outside of the normal window (i.e., Week 22). 
 
Follow-up exercise stress tests that cannot be completed within 3 months of the end of 
the normal window due to the COVID-19 pandemic and clinical research restrictions will 
not be (re)scheduled. Participants will receive partial compensation for completing other 
research activities at this assessment period. Affected participants will be notified of this 
change by study staff via telephone or other method of communication used to contact 
participants during the course of the study.  
 
Participants who have provided verbal consent to participate in Phase 1 and who have 
completed the baseline questionnaires, but whose Phase 1 stress tests have been 
cancelled, will receive partial compensation for their time and effort. Additionally, we will 
ask these participants to complete the baseline questionnaire again when in-person 
research activities resume and their stress tests are rescheduled. Participants will 

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53 
receive full compensation for participating in Phase 1 if the questionnaire and other 
study activities are completed, meaning that participants will be compensated for both 
completed administrations of the baseline questionnaire. These procedures are 
necessary to ensure that the questionnaire data reflects the same timeframe as data 
obtained from the exercise stress test. 
The above modifications will be in effect when necessary as indicated by clinical research 
guidelines issued by NCH, including the Research Institute and Center for Biobehavioral Health. 
The standard protocol will apply when no clinical research restrictions are in place, or when the 
provisions in the modified protocol are not applicable to the participant/study activity. 
The above modifications will be documented for all affected participants, and we will report 
these deviations to the IRB and DSMB in the context of routine continuing reviews and safety 
meetings, respectively.  
 
 

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15 
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