NCT03435354.

Study name	Impacting child physical and mental health outcomes in congenital heart disease: a randomized, controlled trial of enhanced physical activity support in clinical care
Methods	Cluster‐randomized trial, with randomization by within each site by week (i.e. site‐week)
Participants	Inclusion criteria: All patients 5 to 17 years with CHD diagnoses classified as moderate or severe in complexity by the American College of Cardiology/American Heart Association joint guidelines. Exclusion criteria: Cardiac intervention (catheterization or surgery) in preceding 6 months. Syndrome/diagnosis affecting physical activity (e.g., developmental disability) or the ability to complete the assessment questionnaires.
Interventions	Clinician counselling about physical activity using standardised tools to promote daily physical activity.
Outcomes	Primary outcome: Pedometer step counts per day Change in daily physical activity (time frame: baseline then first week of each month for 6 months) Secondary outcomes: Children's Self‐Perceived Adequacy and Predilection for Physical Activity Scale Paediatric Quality of Life Inventory (PedsQL), PLAY Tools Run2 and screening question Change in physical activity adequacy and predilection (time frame: baseline, 6 months)(time frame: baseline, 6 months) Change in quality of life (time frame: baseline, 6 months) Change in physical literacy (time frame: baseline, 6 months)
Starting date	March 5, 2018
Contact information	Principal Investigator: Patricia Longmuir, PhD Scientist
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