Establishing Efficacy for the Congenital Heart Disease Physical Activity Lifestyle Intervention

What this Trial Is About

Researchers are evaluating a lifestyle intervention program called CHD-PAL V.2 aimed at adolescents and young adults aged 15 to 25 with moderate or complex congenital heart disease (CHD). This trial seeks to improve cardiovascular outcomes for CHD survivors transitioning into adulthood, who face risks of cardiovascular comorbidities like coronary disease and hypertension. The study focuses on encouraging safe physical activity to help prevent these health issues in this population. Participants will be randomly assigned to one of two groups: the CHD-PAL intervention or an attention control group. Both groups will receive a Fitbit device and a personalized exercise prescription based on baseline exercise stress test results. The CHD-PAL group will take part in nine virtual coaching sessions over 20 weeks, focusing on changing attitudes, social norms, and perceived control around physical activity using cognitive behavioral strategies from the Theory of Planned Behavior. The control group will also have nine virtual sessions covering healthy lifestyle topics but without behavioral coaching or goal-setting. Both groups receive text messages to support engagement. Participants will be assessed at multiple time points: baseline, mid-intervention (10 weeks), post-intervention (20 weeks), and follow-ups at 40 and 80 weeks. Physical activity levels will be measured using research-grade accelerometers, and cardiorespiratory fitness will be evaluated through stress testing at baseline and post-intervention. Researchers aim to measure changes in moderate to vigorous physical activity, attitudes and social norms related to activity, and fitness over time to determine the intervention's effectiveness and explore the behavioral mechanisms involved.

Congenital Heart Disease Physical Activity Lifestyle Study V.2