Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians

Recruiting now · Not applicable

Conditions studied: Congenital Heart Disease, Pediatric ALL

In brief

Congenital heart disease (CHD) affects approximately 1% of live births, and children with CHD often fail to meet WHO physical activity guidelines. Digital interventions to promote physical activity in CHD patients are limited. This study will develop and test a 12-week digital lifestyle intervention for children (ages 8-13) and their guardians, using a Garmin Vivofit Jr. 2 wearable to continuously monitor physical activity (PA). We will assess its impact on children's moderate to vigorous intensity physical activity (MVPA), daily activity (steps per day), quality of life, nutrition, and health literacy, as well as the quality of life and health literacy of their parents.

Key facts

Study ID

NCT06626672

Run by

Deutsches Herzzentrum Muenchen

People needed

60

Starts

2024-10-01

Expected to finish

2026-02-01

Last updated by the study team

2025-01-29

Who can join

Age: 8 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 8-14 years
• Presence of a congenital heart defect (must be moderate or complex according to ACC criteria)
• NYHA Class I or II
• Presence of written informed consent

You may not qualify if…

• Cognitive impairments that inhibit patients from understanding the tasks
• No sports clearance by paediatric cardiologists

Where it is running

• Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM) — München, Germany (enrolling)

Full record on ClinicalTrials.gov

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