NCT06626672

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

Digital Lifestyle Intervention to Promote Physical Activity, Nutrition, and Health Literacy in Children With Congenital Heart Disease and Their Guardians

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 8 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Congenital Heart Disease
• Pediatric ALL

Interventions

Type	Name	Description
BEHAVIORAL	Digital Health Intervention	Access to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-01-01
• Completion: 2026-02-01
• First posted: 2024-10-04
• Last updated: 2025-01-29

Locations

1 site across 1 country: Germany