Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital Health Intervention.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease, Pediatric ALL. Basic parameters: 8 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Digital Lifestyle Intervention to Promote Physical Activity, Nutrition, and Health Literacy in Children With Congenital Heart Disease and Their Guardians
Overview
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.
Interventions
- Behavioral Digital Health Intervention
Access to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour.
Primary outcome measures
- Physical activity [Time frame: 12 weeks]
Secondary outcome measures (7)
- Daily step count [Time frame: 12 weeks]
- Health-related quality of life [Time frame: Baseline, after 6 weeks, after 12 weeks]
- Physical Activity Health Literacy [Time frame: Baseline, after 6 weeks, after 12 weeks]
- Nutritional Health Literacy [Time frame: Baseline, after 6 weeks, after 12 weeks]
- Health-Related Quality of Life: Parent Version (Proxy-Report) [Time frame: Baseline, after 6 weeks, after 12 weeks]
- Health Literacy for Children [Time frame: Baseline, after 6 weeks, after 12 weeks]
- Health Literacy for Adults [Time frame: Baseline, after 6 weeks, after 12 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Cognitive impairments that inhibit patients from understanding the tasks
- No sports clearance by paediatric cardiologists
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of t — München
Identifiers
NCT: NCT06626672 · 2024-337-S-SB