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

NCT06626672 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-29

No results posted yet for this study

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

BEHAVIORAL

Digital Health Intervention

Access to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour.

Sponsors & Collaborators

  • Technical University of Munich

    collaborator OTHER

  • Stiftung KinderHerz Deutschland gGmbH

    collaborator UNKNOWN

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Jan Müller, Prof. Dr. · Technical University of Munich, Chair of preventive perdiatrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-01-31
Completion
2026-02-28

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06626672 on ClinicalTrials.gov