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

Sponsor
Deutsches Herzzentrum Muenchen
Study ID
NCT06626672
Status
Recruiting
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Conditions

  • Congenital Heart Disease
  • Pediatric ALL

Eligibility Criteria

Sex
ALL
Age
8 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

First listed
Oct 4, 2024
Start date
Oct 1, 2024
Status verified
Jan 2025
Primary completion
Jan 31, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Digital Health Intervention
    Children and their guardians are given access to a 12-week digital platform with content to improve their lifestyle. Physical activity is monitored with a Garmin Vivofit Jr. 2.
  • No Intervention: Control
    During 12-week control period participants receive no access the digital platform. Physical activity is monitored with a Garmin Vivofit Jr. 2.

Primary Outcome Measure

Physical activity [ Time Frame: 12 weeks ]

Central Contacts

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