Lifestyle intervention for adolescents and young adults with congenital heart disease
Establishing Efficacy for the Congenital Heart Disease Physical Activity Lifestyle Intervention
This study is testing a personalized program to help teenagers and young adults with congenital heart disease get active and improve their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 15 Years to 25 Years |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06003023 on ClinicalTrials.gov |
What this trial studies
The Congenital Heart Disease Physical Activity Lifestyle Intervention Study (CHD-PALS) V.2 aims to evaluate the effectiveness of a tailored lifestyle intervention program for adolescents and young adults (AYAs) diagnosed with congenital heart disease (CHD). This program focuses on promoting safe physical activity through individualized guidance provided by trained health professionals. The intervention is based on the Theory of Planned Behavior and includes goal-setting and self-monitoring components to encourage participants to engage in regular physical activity. The study will randomize 144 participants to assess the impact of this intervention on cardiovascular health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents and young adults aged 15-25 years with moderate or complex congenital heart disease who are receiving care from a cardiologist.
Not a fit: Patients who are already engaging in high levels of physical activity or have contraindications to exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cardiovascular health and quality of life for adolescents and young adults with congenital heart disease.
How similar studies have performed: Previous studies have shown positive outcomes with lifestyle interventions for improving physical activity and cardiovascular health in similar populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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)
Where this trial is running
Columbus, Ohio
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jamie L Jackson, PhD — Nationwide Children's Hospital
- Study coordinator: Jamie L Jackson, PhD
- Email: jamie.jackson2@nationwidechildrens.org
- Phone: 6147223585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.