Clinical Trial

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

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated January 29, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-02.
Status change: Not Yet Recruiting → Recruiting 2025-01-27
Trial Details
NCT Number NCT06626672
Lead Sponsor Deutsches Herzzentrum Muenchen
Collaborators: Technical University of Munich, Stiftung KinderHerz Deutschland gGmbH
Conditions Congenital Heart Disease, Pediatric ALL
Enrollment 60 participants
Start Date 2024-10-01
Primary Completion 2026-01 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2025-01-29