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

German Heart Center Munich

Status: Enrolling

Conditions: Pediatric ALL; Congenital Heart Disease

Treatments: Behavioral: Digital Health Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06626672

2024-337-S-SB

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 8 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Digital Health Intervention

Experimental group

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.

Treatment:

Behavioral: Digital Health Intervention

Control

No Intervention group

Description:

During 12-week control period participants receive no access the digital platform. Physical activity is monitored with a Garmin Vivofit Jr. 2.