Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Congenital Heart Disease | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Health Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Digital Health Intervention
- description
- 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.
- interventionNames
- Behavioral: Digital Health Intervention
- type
- NO_INTERVENTION
- label
- Control
- description
- During 12-week control period participants receive no access the digital platform. Physical activity is monitored with a Garmin Vivofit Jr. 2.
Primary outcomes (1)
- measure
- Physical activity
- timeFrame
- 12 weeks
- description
- Physical activity is objectively assessed with the wrist worn wearable "Garmin vivofit jr. 2". Daily physical activity is measured on the basis of active minutes in moderate-to-vigorous intensity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 14 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available