Congenital Heart Disease Physical Activity Lifestyle Study V.2
CHD-PALS V2
Establishing Efficacy for the Congenital Heart Disease Physical Activity Lifestyle Intervention
2 other identifiers
interventional
144
1 country
1
Brief Summary
The Congenital Heart Disease Physical Activity Lifestyle Intervention Study (CHD-PALS) V.2 seeks to determine the efficacy of a lifestyle intervention program for adolescents and young adults (AYAs) with congenital heart disease (CHD). This trial was adapted from the original CHD-PAL trial to continue improving cardiovascular outcomes for transition-aged CHD survivors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 18, 2023
CompletedFirst Submitted
Initial submission to the registry
August 2, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
ExpectedApril 4, 2025
April 1, 2025
2.7 years
August 2, 2023
April 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Moderate to Vigorous Physical Activity (MVPA)
Number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer.
Baseline to Weeks 20, 40, and 80
Secondary Outcomes (6)
Physical Activity Enjoyment/Engagement Scale (Attitudes)
Baseline to Weeks 10, 20, 40, and 80
Affective Attitudes for Physical Activity Scale (Attitudes)
Baseline to Weeks 10, 20, 40, and 80
Physical Activity Norms Measure (Social Norms)
Baseline to Weeks 10, 20, 40, and 80
Family and Partner Support for Physical Activity Engagement Measure (Social Norms)
Baseline to Weeks 10, 20, 40, and 80
Perceived Control for Physical Activity Engagement Measure (Perceived Control)
Baseline to Weeks 10, 20, 40, and 80
- +1 more secondary outcomes
Other Outcomes (2)
Cardiorespiratory Fitness-Volume of Oxygen Consumption (Peak VO2)
Baseline to Week 20
Cardiorespiratory Fitness- Metabolic Equivalents (METs)
Baseline to Week 20
Study Arms (2)
Living Well with Congenital Heart Disease (LIV-CHD) Intervention
ACTIVE COMPARATORIn LIV-CHD, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on how to use the Fitbit along with health education pertinent to living a healthy lifestyle (e.g., sleep hygiene, stress management). Goal-setting and other cognitive behavioral strategies for health behavior change will not be discussed in this arm. Participants in the attention control arm will also receive text messages reminding them to wear their Fitbit.
Congenital Heart Disease Physical Activity Lifestyle (CHD-PAL) Intervention
EXPERIMENTALIn CHD-PAL, participants will receive a Fitbit and a tailored exercise prescription, as devised from their baseline exercise stress test results. They will also meet with a health coach for 9 virtual sessions over a period of 20 weeks. The content will focus on cognitive behavioral strategies, grounded in the Theory of Planned Behavior, to increase physical activity and healthy living. Participants in the intervention arm will also receive text motivational messages relevant to session content, as well as reminders to wear their Fitbit.
Interventions
A physical activity monitor (Fitbit) will be provided to participants in both arms.
Participants in both arms will receive the results of their exercise stress test, which includes information on the duration, frequency, and intensity of their physical activity.
Participants in both arms will receive information on healthy living, including topics such as physical activity, sleep, stress management, and diet.
Participants randomized to the CHD-PAL arm will receive coaching to: 1) change attitudes towards physical activity; 2) increase perceptions of other people's approval of physical activity; 3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance and will be accompanied by goal-setting.
Eligibility Criteria
You may qualify if:
- Between the ages of 15-25 years
- Diagnosed with moderate or complex structural CHD
- Actively receiving care from a cardiologist at Nationwide Children's Hospital (NCH) or Ohio State University (OSU)
You may not qualify if:
- Unable to speak and read proficiently in English
- Have a diagnosis of a genetic syndrome that impacts multiple organ systems
- Have cognitive impairments that would interfere with completing study measures
- Have been engaged in a formal exercise program within the past 6 months,
- Have participated in the intervention arm of the previous CHD-PAL Study
- Have undergone open-heart surgery or had a valve replacement in the last 3 months
- Are unable to complete an exercise stress test using a treadmill
- Are pregnant
- Are prohibited to engage in at least moderate levels of physical activity by their cardiologist
- Engage in \>30 minutes of moderate-to-vigorous physical activity per day, on average per accelerometer
- Have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jamie Jacksonlead
- National Institute of Nursing Research (NINR)collaborator
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie L Jackson, PhD
Nationwide Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Group assignment will be generated through the data capture system (REDCap) in which the randomization scheme was developed by the study statistician. Investigator, research assistants, coaches (interventionists), and participants do not know which condition a participant is in until after Phase 2 consent.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 2, 2023
First Posted
August 21, 2023
Study Start
July 18, 2023
Primary Completion
April 1, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
April 4, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share