Lifestyle intervention for adolescents and young adults with congenital heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.