Establishing Efficacy for the Congenital Heart Disease Physical Activity Lifestyle Intervention
Jamie Jackson
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.
Description
Current estimates indicate more than 2 million individuals in the United States have CHD. CHD survivors are now living well into adulthood, including those with moderate and complex forms of CHD, who previously did not survive childhood. However, adult CHD survivors are now encountering cardiovascular comorbidities, such as coronary disease and hypertension, costing more than $3.16 billion annually in hospitalizations and resulting in premature death. The benefits of physical activity for preventing coronary artery disease and other cardiac comorbidities are well-known. For CHD survivors, the…
Eligibility
- Age range
- 15–25 years
- Sex
- All
- Healthy volunteers
- No
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 St…
Interventions
- BehavioralPhysical Activity Monitoring
A physical activity monitor (Fitbit) will be provided to participants in both arms.
- BehavioralTailored Exercise Prescription
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.
- BehavioralHealthy Lifestyle Education
Participants in both arms will receive information on healthy living, including topics such as physical activity, sleep, stress management, and diet.
- BehavioralPhysical Activity Lifestyle Intervention Informed by the Theory of Planned Behavior
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.
Location
- Nationwide Children's HospitalColumbus, Ohio