Physical Activity Lifestyle Intervention for Young Adults With Congenital Heart Disease
Phase: NA
Conditions: Cardiovascular Disease Other, Physical Activity
Sponsor: Jamie Jackson

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 
 ____________________________________________________________________________________________ 
i 
 
 
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  
 
30 April 2021 
 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 
 ____________________________________________________________________________________________ 
ii 
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. 
 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 
 ____________________________________________________________________________________________ 
iii 
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: 
10/29/2019 
 
Name 
Title 
 
 
 
* The protocol should be signed by the local investigator who is responsible for the study implementation at his/her 
specific site. 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 
 ____________________________________________________________________________________________ 
iv 
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 
Intervention 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 
5.4.1 
Session Description ..................................................................................... 26 
5.5 
Modification of Study Intervention ........................................................................... 27 
5.6 
Accountability Procedures for the Study Intervention ............................................. 28 
5.7 
Assessment of Subject Compliance with Study Intervention .................................. 28 
5.8 
Concomitant Treatments ......................................................................................... 28 
6 
Study Schedule, Study Procedures/ Evaluations ................................................................ 29 
6.1 
Screening ................................................................................................................. 29 
6.2 
Phase 1: Enrollment/Baseline (T1) .......................................................................... 29 
6.3 
Phase 2: Enrollment in the RCT .............................................................................. 30 
6.4 
Interim Assessment (between weeks 8-12) ............................................................ 30 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 
 ____________________________________________________________________________________________ 
v 
6.5 
Post-Intervention (between weeks 20-26) ............................................................... 31 
6.6 
Focus Groups (after post-intervention assessment) ............................................... 32 
6.7 
Additional Incentive .................................................................................................. 32 
7 
Assessment of Safety .......................................................................................................... 33 
7.1 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters.33 
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 
7.1.3 
Other Medical Events .................................................................................. 35 
7.1.4 
Unanticipated Problems ............................................................................... 35 
7.2 
Reporting Procedures .............................................................................................. 35 
7.2.1 
Adverse Events ............................................................................................ 35 
7.2.2 
Serious Adverse Events .............................................................................. 35 
7.2.3 
Unanticipated Problems ............................................................................... 36 
7.3 
Type and Duration of Follow-up of Subjects after Adverse Events and Unanticipated Problems
.................................................................................................................................. 36 
7.4 
Halting Rules ............................................................................................................ 36 
7.5 
Safety Oversight ...................................................................................................... 37 
7.6 
Study Hypotheses .................................................................................................... 37 
7.7 
Sample Size Considerations ................................................................................... 37 
Planned Interim Analyses (if applicable) ............................................................................. 38 
7.8 
Analysis Plan............................................................................................................ 38 
8 
Source Documents and Access to Source Data/Documents ............................................. 39 
9 
Quality Control and Quality Assurance ............................................................................... 40 
10 
Ethics/Protection of Human Subjects .................................................................................. 41 
10.1 
Ethical Standard ....................................................................................................... 41 
10.2 
Institutional Review Board ....................................................................................... 41 
10.3 
Informed Consent Process ...................................................................................... 41 
10.4 
Subject Confidentiality ............................................................................................. 42 
10.5 
Study Discontinuation .............................................................................................. 42 
11 
Data Handling and Record Keeping .................................................................................... 43 
11.1 
Data Management Responsibilities ......................................................................... 43 
11.2 
Data Capture Methods ............................................................................................. 43 
11.3 
Types of Data ........................................................................................................... 44 
11.4 
Study Records Retention ......................................................................................... 44 
11.5 
Protocol Deviations .................................................................................................. 44 
12 
Publication Policy ................................................................................................................. 45 
13     PHI Recording…………………………………………………………………………………….46 
14     Temporary Changes in Protocol in Response to COVID-19…………………………………49 
15 
Literature References .......................................................................................................... 52 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 
 ____________________________________________________________________________________________ 
vi 
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 
 
 
 
 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 
 ____________________________________________________________________________________________ 
vii 
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 current study adapts a PA 
lifestyle intervention to young adult CHD survivors (ages 18 – 25) 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 up to 90 young adults will 
participate in Phase 1 to determine participants’ eligibility for Phase 2. Phase 2 
is the randomized control trial in which a total of 40 young adults 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 up to 90 young adults (ages 18 – 25 
at enrollment) who have moderate to complex CHD. For Phase 2 we aim to 
recruit 40 young adults (~17 per arm). 
 
 
Study Duration: 
2 years (2019-2021) 
 
 
Participation Duration: 
Phase 1:  2 weeks 
Phase 2: 22 weeks  
 
 
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 
exercise prescription, and 8 videoconferencing sessions with a PA coach, 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 
 ____________________________________________________________________________________________ 
viii 
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 
Planned 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 young adult CHD survivors at 
greater risk for future morbidity due to having more complex disease. This 
will involve (1) evaluating the feasibility of the intervention and (2) obtaining 
qualitative feedback from participants on the content of the intervention 
sessions and study procedures using focus groups. We hypothesize that 
young adults will rate participating in as enjoyable, easy, relevant, and 
useful. Additionally, qualitative data about participants’ study experiences 
will inform modifications to the session content and study procedures for the 
larger trial. 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 among young adult CHD 
survivors. 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.  
 
 
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): 
2 years 
   

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 
 ____________________________________________________________________________________________ 
ix 
 
 
 
 
 
 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
10 
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 
Study Coordinators: Taylor Swenski, B.S. & Steven Neville, B.A. 
 
Institution: 
 
 
 
Center for Biobehavioral Health 
The Research Institute at Nationwide Children’s Hospital 
700 Children’s Drive 
Columbus, OH 43205 
Phone 614-722-3585 
 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
11 
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 
changes,4 such as increasing PA and decreasing sedentary behavior. 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.5 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.6  
 
Physical activity (PA) engagement and benefits  
An American Heart Association (AHA) Scientific Statement7 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. In fact, newly published 
guidelines for the management of adults with CHD encourage the counseling of adult CHD 
survivors on PA for both prevention and treatment of comorbidities that increase risk for premature 
mortality.8  Positive health behaviors often decline during adolescence and young adulthood, and 
CHD survivors are no exception, which may lead to poor health behaviors later in adulthood.9-12 
Young adulthood (18-25 years old) is a unique developmental stage hallmarked by instability (e.g., 
romantic relationships and job changes), as well as greater focus on qualities of character, such as 
accepting responsibility for one’s self.13 Heightened risk behaviors identified during young adulthood 
may be due to identity exploration during this developmental period,13 which may contribute to 
poorer disease self-management. For CHD survivors, this developmental period is also 
characterized by increased likelihood for lapses in care and/or loss to follow-up,14,15  transfer of care 
to an adult medical setting, and assuming greater responsibility for managing one’s disease. In the 
U.S., PA steadily declines during young adulthood before stabilizing in middle adulthood.16 
Furthermore, sex differences have been identified, such that males are more likely to report 
sustained PA during adulthood than females.16 Given the enhanced focus on responsibility for one’s 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
12 
self and their future, young adulthood is an optimal developmental stage during which to conduct a 
health behavior lifestyle intervention. 
 
Sedentary behavior (SB) is a risk factor  
In addition to promoting moderate to vigorous physical activity (MVPA), a scientific statement by 
the AHA7 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 
using computers.17 A similar pattern of increased SB over time has been identified in children 
and adolescents with CHD.18  Time spent in SB among young adult CHD survivors via an 
objective measure of PA has only been documented by 1 study of 15 participants in Canada, 
which reported approximately 9.5 hours of SB/day.19 Longitudinal research in the general 
population has identified increased time spent on the computer from adolescence to young 
adulthood, which may be an important contributor to greater SB in this age group.20 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 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.21 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 Behavior22 has been used as a framework for lifestyle 
interventions, including among individuals with heart failure23-25 and rural populations with multiple 
cardiovascular risk factors.26 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-

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
13 
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.27,28 Furthermore, poorer self-efficacy has been 
associated with lower levels of PA, as measured via accelerometer, among adults with CHD,29 
suggesting that targeting self-efficacy may positively influence PA engagement. 
 
Objective measures to assess physical activity (PA)  
Studies reporting MVPA in adults with CHD using accelerometry, the gold standard for 
measuring PA, are limited and none have emerged from the U.S. 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 young adults.19Only 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.32 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 young 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.  
 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
14 
Utilizing technology to facilitate behavior change: Videoconferencing and a popular 
activity tracker (Fitbit®) 
Videoconferencing behavioral interventions have demonstrated feasibility among adults at risk 
for cardiovascular disease.35 Videoconferencing as a mode of delivery for 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.36 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.37 Fitbits have been used with adolescents to track sleep,38,39 and PA40 in children with 
complex CHD as well as in interventions to increase PA levels among young adults with other 
chronic illnesses.41,42 
2.2 
Rationale 
 
If young adults 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,43 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 failure23-25 and rural populations with multiple cardiovascular disease risk 
factors26. A few small studies44,45 have reported positive effects of exercise training interventions 
on functional among adults with CHD. However, the mechanisms of these changes are 
unknown, limiting the ability to identify potential targets of intervention to promote sustained 
behavioral change. 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 identification of potential mechanisms of 
behavior change, such as attitudes, subjective norms and perceived control. Understanding the 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
15 
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 
young adult CHD survivors who are at greater risk for future morbidity due to having more 
complex disease. This will involve (1) evaluating the feasibility of the intervention and (2) 
obtaining qualitative feedback from participants on the content of the intervention sessions and 
study procedures using focus groups. We hypothesize that young adults will rate participating in 
as enjoyable, easy, relevant, and useful. Additionally, qualitative data about participants’ study 
experiences will inform modifications to the session content and study procedures for the larger 
trial. 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 
among young adult CHD survivors. 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 18 to 25 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.5 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 (2 focus groups with 5-8 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 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.27,28 Furthermore, poorer self-efficacy has been 
associated with lower levels of PA, among adults with CHD,29 suggesting that targeting self-

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
16 
efficacy may positively influence PA engagement. 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 in interventions to increase PA levels among young adults with other chronic illnesses.41,42  
 
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 young adult is able to safely 
engage in MVPA. After receiving the cardiologist’s approval and the CHD survivor 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, 
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 
cardiology check-up that are concerning to the participant, the interventionist (i.e. PA coaches) 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
17 
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 
secured research network, as well as on the hospital’s secure Windows OneDrive platform. 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
18 
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 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. 
 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
19 
3 
OBJECTIVES 
3.1 
Study Objectives 
A total of up to 90 young adults (ages 18 -25) 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 40 young adults. The aims of the study are to: 
 
1. Aim 1: Evaluate the feasibility of the intervention.  
Hypothesis 1: Young adults will rate participating in the intervention as enjoyable, 
easy, relevant, and useful. 
 
2. Aim 2: Obtain qualitative feedback on session content and study procedures from 
participants using focus groups. 
 
 
3.2 
Study Outcome Measures 
3.2.1 Primary Outcome Measure 
Enjoyment of the intervention, ease of participation, applicableness of session content, and 
helpfulness of the intervention. 
3.2.2 Intervention Outcome Measures 
Number of minutes spent in MVPA as measured by an accelerometer (primary intervention 
outcome). 
Number of minutes spent being sedentary as measured by an accelerometer (secondary 
intervention outcome). 
Maximal oxygen utilization during PA as measured by VO2max during an exercise stress test 
(secondary intervention outcome). 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
20 
3.2.3 Other Outcome Measures 
Health-related quality of life as measured by the Patient-Reported Outcomes Measurement 
Information System (PROMIS).46-48 
Self-reported PA as measured by the International Physical Activity Questionnaire (IPAQ).49,50 
3.2.4 Purported Mechanisms 
 
PA attitudes as measured by the Benefits of PA questionnaire51. 
 
PA subjective norms as measured by the PA Subjective Norms52 and the Social Support for PA53 
surveys. 
  
PA perceived control as measured by the Barriers to Exercise survey54 and the Self-Efficacy for 
Exercise Scale.55 
3.2.5 Other Exploratory Predictors 
 
Cardiac-related anxiety as measured by the Cardiac Anxiety Questionnaire.56 
 
Self-consciousness of body due to cardiac interventions scars as measured by the modified Body 
Image Disturbance Questionnaire.57 
 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
21 
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. Once the exercise stress test is 
completed and the accelerometer is returned, participants are compensated $100. Parking and 
mileage 
reimbursement 
to/from 
the 
hospital 
is 
provided.  
 
If a participant engages in <150 minutes of MVPA per week 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 (<25 min/day of MVPA vs. >26-59 
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, 
participants in both arms are asked to engage in a post-intervention assessment, consisting of 30-

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
22 
45 minutes of questionnaires, wearing an accelerometer for 7 days, and undergoing a final exercise 
stress test. Participants are compensated $100. 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 2 groups 
that meet via videoconferencing with 5-8 participants per group. Participants who attend the focus 
group will be compensated $50.  
 
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.  
 
 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
23 
5 
STUDY ENROLLMENT AND WITHDRAWAL 
The total target sample size for enrollment in Phase 1 is up to 90 participants and in Phase 2, 40 
participants (~17 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 (18 
– 25 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 young adult from participating, 
including limitations to engaging in MVPA. Next, the patient 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 potential participant can call and leave a message if they do 
not wish to be contacted. Approximately 1 week later, if no message was received, patients are 
called by study personnel. During the phone conversation, the objectives and primary components 
of the study are discussed. If a patient is interested, verbal consent is obtained for completing online 
questionnaires and the exercise stress test at NCH is scheduled. During the stress test visit, written 
consent for the stress test and accelerometer assessment is obtained. If a patient 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 18 and 25 years of age  
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 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
24 
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 >150 min/week 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. 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
25 
Randomization is stratified by the number of minutes spent in MVPA per the accelerometer data in 
Phase 1 (<25 min/day of MVPA vs. >26-59 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 young and 
middle-aged adults with CHD.19,29 
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 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 requests 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,7 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.  

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
26 
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) and post-intervention (between weeks 20-26) 
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. 
5.4.1 Session Description 
Session 1 (Week 1) 
Coaches inquire about participants’ attitudes about PA and encourage them to get familiarized 
with their Fitbit. 
Session 2 (Week 2) 
Participants’ are encouraged to discuss their knowledge about PA and to think about pros and 
cons for engaging in PA. Goals are set in collaboration with the participant, including increasing 
participants’ PA frequency, duration, or intensity. 
Session 3 (Week 3) 
Coaches inquire about participants PA self-efficacy/perceived control by asking what gets in the 
way of engaging in activities that the participant enjoys and troubleshoot around controllable 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
27 
barriers. Participants are also encouraged to try a new type of PA. Goals are set for increasing 
frequency, duration, or intensity when engaging in PA. 
Session 4 (Week 4) 
Coaches will inquire about participants PA subjective norms (e.g., “Have you talked with your 
caregivers/siblings/friends/cardiologist about being active?” “What do they think about you being 
active?”), and are encouraged to talk to family/friends/cardiologist about being active if they 
have not, as well as invite family/friends to join them in physical activities. Goals are set to 
increase frequency, duration, or intensity of PA. 
Session 5 (Week 6) 
Coaches promote participants’ independence by modeling the use of core concepts from the 
Theory of Planned Behavior learned in Sessions 1-4 with emphasis placed on managing 
barriers and promoting boosters to PA. Participants are encouraged to increase frequency, 
duration, or intensity of PA based on what they perceived as being the easiest to increase.  
Session 6 (Week 8) 
Coaches continue promoting participants’ independence by discussing the process of goal-
setting, including making achievable goals and anticipating barriers. Participants are asked to 
set up his/her goals in respect to increase frequency, duration, or intensity of PA.  
Session 7 (Week 12) 
Coaches continue promoting participants’ independence by reflecting about their progress and 
discussing the process of setting long-term goals. Participants are encouraged to set new goals 
ever 2 weeks during the span between Session 7 and 8. Coaches help participants identify 
potential barriers to achieving their goals, as well as how they can continue to use their Fitbit for 
self-monitoring. 
Session 8 (Week 20) 
Coaches summarize the intervention, focusing on the participant’s successes and gains. 
Coaches will also inquire about participants’ motivation and promote maintenance. 
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.  

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
28 
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.  
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.  
   

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
29 
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 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 has consented, 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  
Benefits of PA51  
Subjective Norms survey52  
Social Support for Exercise survey53,55  
Barriers to Exercise survey54  
Self-Efficacy for Exercise Scale55  
Patient-Reported Outcomes Measurement Information System46-48  
International Physical Activity Questionnaire49,50  
Cardiac Anxiety Questionnaire56  
Modified Body Image Disturbance Questionnaire57 
Physical Activity Stages of Change Questionnaire – Algorithm58 
Physical Activity Stages of Change Questionnaire - Continuous59-61  
 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
30 
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 150 minutes of MVPA per week, they are not eligible for Phase 2. 
 
Compensation: 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. Home visits may 
also be conducted virtually (e.g., via Google Hangouts). Participants completing virtual home visits 
will receive study materials by postal mail or email as appropriate.  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 envelope, the study PI, 
study staff, and the participant are blind to the study arm designation. 
6.4 
Interim Assessment (between weeks 8-12) 
 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
31 
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 PA51  
Subjective Norms survey52  
Social Support for Exercise survey53  
Barriers to Exercise survey54  
Self-Efficacy for Exercise Scale55  
Patient-Reported Outcomes Measurement Information System46-48  
International Physical Activity Questionnaire49,50  
Cardiac Anxiety Questionnaire56  
Changes in Health 
Physical Activity Stages of Change Questionnaire – Algorithm58 
Physical Activity Stages of Change Questionnaire - Continuous59-61  
 
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 are 
asked to rate the intervention on multiple dimensions.   
Benefits of PA51  
Subjective Norms survey52 Social Support for Exercise survey53  
Barriers to Exercise survey54  

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
32 
Self-Efficacy for Exercise Scale55  
Patient-Reported Outcomes Measurement Information System46-48  
International Physical Activity Questionnaire49,50  
Cardiac Anxiety Questionnaire56  
Changes in Health  
Post-Intervention Satisfaction 
Physical Activity Stages of Change Questionnaire – Algorithm58 
Physical Activity Stages of Change Questionnaire - Continuous59-61  
 
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: 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 2 groups that meet via 
videoconferencing with 5-8 participants per group. 
 
Compensation: Participants are compensated $50 for being in the focus group. 
 
6.7 
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.  

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
33 
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. 
 
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. 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
34 
 
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 medical 
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 young 
adult 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 a young adult 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 young adult 
contact their cardiologist. Young adults 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 young adult 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 
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.   

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
35 
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 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.  
7.1.3 Other Medical Events 
Medical events not meeting the above definition of an adverse event.  
7.1.4 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. 
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. 
 
7.2.2 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. 
 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
36 
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.  
7.2.3 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 
and Unanticipated Problems 
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 
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 an unexpected serious adverse event, an ad hoc 
meeting will commence that will include the PI, study physician, and the DSMB to determine if 
enrollment needs to be temporarily suspended until a safety review is convened. If a safety review 
is conducted, the DSMB will decide whether the study should continue per protocol, proceed with 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
37 
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 
 
Hypothesis 1: Young adults are hypothesized to rate the intervention as enjoyable, easy, 
relevant, and useful.  
 
7.7 
Sample Size Considerations 
The sample size of 40 for the Phase 2 RCT component is obtainable in the 2-year timeframe of this 
study and is adequate for addressing the study aims for determining feasibility (i.e., intervention 
acceptability, recruitment rate, retention rate, intervention session adherence, and assessment 
completion rate). The current sample size is not powered to detect treatment effects and is not 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
38 
intended to be used for effect size estimation due to the risk of under or overestimating the sample 
size for the larger study62,63.   
Planned Interim Analyses (if applicable) 
No interim analysis is planned.  
7.8 
Analysis Plan 
 
Aim 1: Evaluate the feasibility of the intervention.  
 
Objective indicators of feasibility will be evaluated, including recruitment rate (# recruited divided 
by # approached), adherence to intervention sessions (% sessions completed per participant), 
retention rate (# drop outs divided by # randomized) and assessment completion rate (% of 
participants who completed each assessment and the timeframe in which completed). 
Participants will also rate the intervention on multiple dimensions, and mean/median ratings will 
be computed.  
 
 
Aim 2: Obtain qualitative feedback on session content and study procedures from 
participants using focus groups. 
 
Focus group feedback will be transcribed and coded. Themes will be identified using 2 coders, 
and the number of participants who endorse a theme will be tabulated.  

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
39 
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. 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
40 
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. 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
41 
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 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 on the letter is provided so that the 
patient 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 is 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 is interested, verbal consent 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. 
Participants retain a copy of consent forms for their own records. 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
42 
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. 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
43 
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. 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
44 
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. 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
45 
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. 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
46 
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 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
47 
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) 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
48 
☒  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.  
 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
49 
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 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
50 
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 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
51 
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.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
52 
15  LITERATURE REFERENCES 
 
1. 
Moons P, Bovijn L, Budts W, Belmans A, Gewillig M. Temporal trends in survival to 
adulthood among patients born with congenital heart disease from 1970 to 1992 in 
Belgium. Circulation. 2010;122(22):2264-2272. 
2. 
Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 
2002;39(12):1890-1900. 
3. 
Warnes CA, Williams RG, Bashore TM, et al. ACC/AHA 2008 Guidelines for the 
Management of Adults with Congenital Heart Disease: a report of the American 
College of Cardiology/American Heart Association Task Force on Practice 
Guidelines (writing committee to develop guidelines on the management of adults 
with congenital heart disease). Circulation. 2008;118(23):e714-833. 
4. 
Roche SL, Silversides CK. Hypertension, obesity, and coronary artery disease in the 
survivors of congenital heart disease. Can J Cardiol. 2013;29(7):841-848. 
5. 
Greutmann M, Tobler D, Kovacs AH, et al. Increasing mortality burden among adults 
with complex congenital heart disease. Congenit Heart Dis. 2015;10(2):117-127. 
6. 
O'Leary JM, Siddiqi OK, de Ferranti S, Landzberg MJ, Opotowsky AR. The 
Changing Demographics of Congenital Heart Disease Hospitalizations in the United 
States, 1998 Through 2010. JAMA. 2013;309(10):984-986. 
7. 
Longmuir PE, Brothers JA, de Ferranti SD, et al. Promotion of physical activity for 
children and adults with congenital heart disease: a scientific statement from the 
American Heart Association. Circulation. 2013;127(21):2147-2159. 
8. 
Stout KK, Daniels CJ, Aboulhosn JA, et al. 2018 AHA/ACC Guideline for the 
Management of Adults With Congenital Heart Disease: Executive Summary: A 
Report of the American College of Cardiology/American Heart Association Task 
Force on Clinical Practice Guidelines. Circulation. 2019;139(14):e637-e697. 
9. 
McGill HC, McMahan CA, Herderick EE, Malcom GT, Tracy RE, Strong JP. Origin of 
atherosclerosis in childhood and adolescence. Am J Clin Nutr. 2000;72(5 
Suppl):1307S-1315S. 
10. 
Moons P, Van Deyk K, Dedroog D, Troost E, Budts W. Prevalence of cardiovascular 
risk factors in adults with congenital heart disease. Eur J Cardiovasc Prev Rehabil. 
2006;13(4):612-616. 
11. 
Lunt D, Briffa T, Briffa NK, Ramsay J. Physical activity levels of adolescents with 
congenital heart disease. Aust J Physiother. 2003;49(1):43-50. 
12. 
Caspersen CJ, Pereira MA, Curran KM. Changes in physical activity patterns in the 
United States, by sex and cross-sectional age. Med Sci Sports Exerc. 
2000;32(9):1601-1609. 
13. 
Arnett JJ. Emerging adulthood: A theory of development from the late teens through 
the twenties. American Psychologist. 2000;55(5):469-480. 
14. 
Reid GJ, Irvine, M. J., McCrindle, B. W., Sananes, R., Ritvo, P. G., Siu, S. C., & 
Webb, G. D. Prevalence and Correlates of Successful Transfer From Pediatric to 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
53 
Adult Health Care Among a Cohort of Young Adults With Complex Congenital Heart 
Defects. Pediatrics. 2004;113:e197-205. 
15. 
Mackie AS, Ionescu-Ittu R, Therrien J, Pilote L, Abrahamowicz M, Marelli AJ. 
Children and adults with congenital heart disease lost to follow-up: who and when? 
Circulation. 2009;120(4):302-309. 
16. 
Caspersen CJ, Periera, M. A., & Curran, K. M. Changes in physical activity patterns 
in the United States, by sex and cross-sectional age. Medicine & Science in Sports 
& Exercise. 2000;32(9):1601-1609. 
17. 
Tanaka C, Reilly JJ, Huang WY. Longitudinal changes in objectively measured 
sedentary behaviour and their relationship with adiposity in children and 
adolescents: 
systematic 
review 
and 
evidence 
appraisal. 
Obes 
Rev. 
2014;15(10):791-803. 
18. 
Voss C, Duncombe, S. L., Dean, P. H., de Souza, A. M., & Harris, K. C. Physical 
activity and sedentary behavior in children with congenital heart disease. Journal of 
the American Heart Association. 2017;6(3):e004665. 
19. 
McKillop A, McCrindle BW, Dimitropoulos G, Kovacs AH. Physical activity 
perceptions and behaviors among young adults with congenital heart disease: A 
mixed-methods study. Congenit Heart Dis. 2018;13(2):232-240. 
20. 
Taverno Ross SE, Larson N, Graham DJ, Neumark-Sztainer D. Longitudinal 
changes in physical activity and sedentary behavior from adolescence to adulthood: 
comparing U.S.-born and foreign-born populations. J Phys Act Health. 
2014;11(3):519-527. 
21. 
Duppen N, Takken T, Hopman MT, et al. Systematic review of the effects of physical 
exercise training programmes in children and young adults with congenital heart 
disease. Int J Cardiol. 2013;168(3):1779-1787. 
22. 
Ajzen I, Fishbein M. Understanding attitudes and predicting social behavior. 
Englewood, NJ: Prentice Hall; 1980. 
23. 
Wu JR, Corley DJ, Lennie TA, Moser DK. Effect of a medication-taking behavior 
feedback theory-based intervention on outcomes in patients with heart failure. J 
Card Fail. 2012;18(1):1-9. 
24. 
Welsh D, Lennie TA, Marcinek R, et al. Low-sodium diet self-management 
intervention in heart failure: pilot study results. Eur J Cardiovasc Nurs. 
2013;12(1):87-95. 
25. 
Welsh D, Marcinek R, Abshire D, et al. Theory-based low-sodium diet education for 
heart failure patients. Home Healthc Nurse. 2010;28(7):432-441; quiz 441-433. 
26. 
Saleh ZT, Lennie TA, Mudd-Martin G, et al. Decreasing sedentary behavior by 30 
minutes per day reduces cardiovascular disease risk factors in rural Americans. 
Heart Lung. 2015;44(5):382-386. 
27. 
Reybrouck T, Mertens L. Physical performance and physical activity in grown-up 
congenital heart disease. Eur J Cardiovasc Prev Rehabil. 2005;12(5):498-502. 
28. 
Longmuir PE, McCrindle BW. Physical activity restrictions for children after the 
Fontan operation: disagreement between parent, cardiologist, and medical record 
reports. Am Heart J. 2009;157(5):853-859. 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
54 
29. 
Dua JS, Cooper, A. R., Fox, K. R., & Stuart, A. G. Physical activity levels in adults 
with congenital heart disease. European Journal of Cardiovascular Prevention & 
Rehabilitation 2007;14(2):287-293. 
30. 
Dua JS, Cooper AR, Fox KR, Graham Stuart A. Physical activity levels in adults with 
congenital heart disease. Eur J Cardiovasc Prev Rehabil. 2007;14(2):287-293. 
31. 
Sandberg C, Pomeroy J, Thilén U, Gradmark A, Wadell K, Johansson B. Habitual 
Physical Activity in Adults With Congenital Heart Disease Compared With Age- and 
Sex-Matched Controls. Can J Cardiol. 2016;32(4):547-553. 
32. 
U.S. Department of Health and Human Services CfDCaPC, National Center for 
Chronic Disease Prevention and Health Promotion, Division of Nutrition, Physical 
Activity and Obesity in Atlanta, GA. Nutrition, Physical Activity and Obesity Data, 
Trends 
and 
Maps 
web 
site. 
2015; 
Available 
at 
http://www.cdc.gov/nccdphp/DNPAO/index.html. 
33. 
Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials. New York, 
NY: Springer; 2010. 
34. 
Giardini A, Specchia S, Tacy TA, et al. Usefulness of cardiopulmonary exercise to 
predict long-term prognosis in adults with repaired tetralogy of Fallot. Am J Cardiol. 
2007;99(10):1462-1467. 
35. 
Ylimäki EL, Kanste O, Heikkinen H, Bloigu R, Kyngäs H. The effects of a counselling 
intervention on lifestyle change in people at risk of cardiovascular disease. Eur J 
Cardiovasc Nurs. 2015;14(2):153-161. 
36. 
Goldstein F, Glueck D. Developing Rapport and Therapeutic Alliance During 
Telemental Health Sessions with Children and Adolescents. J Child Adolesc 
Psychopharmacol. 2016;26(3):204-211. 
37. 
Lyons EJ, Lewis ZH, Mayrsohn BG, Rowland JL. Behavior change techniques 
implemented in electronic lifestyle activity monitors: a systematic content analysis. J 
Med Internet Res. 2014;16(8):e192. 
38. 
de Zambotti M, Baker FC, Willoughby AR, et al. Measures of sleep and cardiac 
functioning during sleep using a multi-sensory commercially-available wristband in 
adolescents. Physiol Behav. 2016;158:143-149. 
39. 
Meltzer LJ, Hiruma LS, Avis K, Montgomery-Downs H, Valentin J. Comparison of a 
Commercial Accelerometer with Polysomnography and Actigraphy in Children and 
Adolescents. Sleep. 2015;38(8):1323-1330. 
40. 
Jacobsen RM, Ginde S, Mussatto K, Neubauer J, Earing M, Danduran M. Can a 
Home-based Cardiac Physical Activity Program Improve the Physical Function 
Quality of Life in Children with Fontan Circulation? Congenit Heart Dis. 
2016;11(2):175-182. 
41. 
Yurkiewicz IR, Simon, P., Liedtke, M., Dahl, G. & Dunn, T. . Effect of Fitbit and iPad 
wearable technolgoy in health-related quality of life in adolescent and young adult 
cancer patients. Journal of Adolescent and Young Adult Oncology 2018;7(5):579-
583. 
42. 
Mendoza JA, Baker KS, Moreno MA, et al. A Fitbit and Facebook mHealth 
intervention for promoting physical activity among adolescent and young adult 
childhood cancer survivors: A pilot study. Pediatr Blood Cancer. 2017;64(12). 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
55 
43. 
Guerri-Guttenberg RA, Castilla R, Francos GC, Müller A, Ambrosio G, Milei J. 
Transforming growth factor β1 and coronary intimal hyperplasia in pediatric patients 
with congenital heart disease. Can J Cardiol. 2013;29(7):849-857. 
44. 
Sandberg C, Hedstrom, M. , Wadell, K., Dellborg, M., Ahnfelt, A, Zetterstrom, A., 
Ohrn, A., & Johansson, B. . Home-based interval training increases endurance 
capacity in adutls with complex congenital heart disease. Congenit Heart Disease. 
2018;13:254-262. 
45. 
Dua JS, Cooper, A. R., Fox, K. R., & Stuart, A. G. Exercise training in adults with 
congenital heart disease: feasibility and benefits. International Journal of Cardiology. 
2010;138(2):196-205. 
46. 
Reeve BB, Hays RD, Bjorner JB, et al. Psychometric evaluation and calibration of 
health-related quality of life item banks: plans for the Patient-Reported Outcomes 
Measurement Information System (PROMIS). Med Care. 2007;45(5 Suppl 1):S22-
31. 
47. 
Cella D, Yount S, Rothrock N, et al. The Patient-Reported Outcomes Measurement 
Information System (PROMIS): progress of an NIH Roadmap cooperative group 
during its first two years. Med Care. 2007;45(5 Suppl 1):S3-S11. 
48. 
DeWalt DA, Rothrock N, Yount S, Stone AA, Group PC. Evaluation of item 
candidates: the PROMIS qualitative item review. Med Care. 2007;45(5 Suppl 
1):S12-21. 
49. 
Craig CL, Marshall AL, Sjöström M, et al. International physical activity 
questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 
2003;35(8):1381-1395. 
50. 
Pinto Guedes D, Correa  Lopes C, Ribeiro Pinto Guedes JE. Reproducibility and 
validity of the International Physical Activity Questionnaire in adolescents. Brazilian 
Journal of Sports Medicine. 2005;11(2). 
51. 
Calfas KJ, Sallis JF, Nichols JF, et al. Project GRAD: two-year outcomes of a 
randomized controlled physical activity intervention among young adults. Graduate 
Ready for Activity Daily. Am J Prev Med. 2000;18(1):28-37. 
52. 
Motl RW, Dishman RK, Trost SG, et al. Factorial validity and invariance of 
questionnaires measuring social-cognitive determinants of physical activity among 
adolescent girls. Prev Med. 2000;31(5):584-594. 
53. 
Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of 
scales to measure social support for diet and exercise behaviors. Prev Med. 
1987;16(6):825-836. 
54. 
Welsh EM, Jeffery RW, Levy RL, et al. Measuring perceived barriers to healthful 
eating in obese, treatment-seeking adults. J Nutr Educ Behav. 2012;44(6):507-512. 
55. 
JF S, RB P, RM G, TL P, PR N. The development of self-efficacy scales for health-
related diet and exercise behaviors. Health Educ Res. 1988;3:283-292. 
56. 
Eifert GH, Thompson RN, Zvolensky MJ, et al. The cardiac anxiety questionnaire: 
development and preliminary validity. Behav Res Ther. 2000;38(10):1039-1053. 
57. 
Cash TF, Phillipsb KA, Santosc MT, Hraboskyc JI. Measuring “negative body 
image”: validation of the Body Image Disturbance Questionnaire in a nonclinical 
population. Body Image. 2004;1(4):363-372. 

Young Adult CHD Survivors PA Engagement 
Updated: 
 
30 April 2021  
 ____________________________________________________________________________________________ 
 
 ____________________________________________________________________________________________ 
56 
58. 
Robinson A, Norma, G., Sallis, J., Calfas, K., Rock, C., & Patrick, K. Validating stage 
of change measures for physical activity and dietary behaviors for overweight 
women. International Journal of Obesity. 2008;32(7):1137-1144. 
59. 
Ledrdal A, Moe, B., Digre, E., Harding, T., Kristensen, F., Gov, E., Bakken, L., 
Eklund, M., Ruud, I., & Rossi, J. Stages of change - continuous measure (URICA-
E2): psychometrics of a Norwegian version. Journal of Advanced Nursing. 
2009;65(1):193-202. 
60. 
Chen SH, Lai, H. R., Chen, S. R., Lin, P. C., Chou, K. R., & Lee, P. H. Validity and 
reliability of a Chinese-language instrument for continuous assessment of exercise 
stages of chagne in adults Journal of Nursing Research. 2019;27(4):e37. 
61. 
Reed GR. Measuring stage of change for exercise behavior change, URICA-E2. 
Unpublished dissertation. 1994. 
62. 
Thabane L, Ma, J., Chu, R., Cheng, J., Ismaila, A., Rios, L. P., Robson, R., 
Thabane, M., Giagnregorio, L., & Goldsmith, C. H. A tutorial on pilot studies: the 
what, why and how. BMC Medical Research Methodology. 2010;10(1). 
63. 
Kraemer HC, Mintz, J., & Noda, A. Caution Regarding the Use of Pilot Studies to 
Guide Power Calculations for Study Proposals Archives of General Psychiatry. 
2006;63(5):484-489.