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

Not Applicable

Recruiting

• Conditions: Congenital Heart Disease; Pediatric ALL
• Interventions: Behavioral: Digital Health Intervention

• Registration Number: NCT06626672
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-01
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-01
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Health Intervention	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.

Primary Outcome Measures

Name	Time	Method
Physical activity	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Daily step count	12 weeks	Children's daily step count is objectively assessed using the wrist-worn wearable device, Garmin Vivofit Jr. 2.
Health-related quality of life	Baseline, after 6 weeks, after 12 weeks	Children's health-related quality of life is self-assessed via the KINDL® questionnaire. The KINDL® is a generic instrument for assessing health-related quality of life in children and adolescents. The KINDL® is a short, methodologically tested and flexible measurement instrument consisting of 24 questions on the six areas of body/physis, feelings/psychology, self-assessment, family, friends and school.
Physical Activity Health Literacy	Baseline, after 6 weeks, after 12 weeks	Physical Activity Health Literacy Scale for Children (PAHL-C) evaluates children's self-reported knowledge and understanding of physical activity and its benefits through an 8-question scale.
Nutritional Health Literacy	Baseline, after 6 weeks, after 12 weeks	The Nutrition Health Literacy Scale for Children (NHL-C) measures children's self-reported knowledge and understanding of nutrition and healthy eating using an 8-question scale.
Health-Related Quality of Life: Parent Version (Proxy-Report)	Baseline, after 6 weeks, after 12 weeks	The KINDL® proxy-report assesses the child's health-related quality of life from the parent's perspective, using the KINDL® questionnaire designed for parents to provide insights on the child's health-related quality of life.
Health Literacy for Children	Baseline, after 6 weeks, after 12 weeks	Health Literacy Survey Questionnaire for Children (HLS-Child-Q15) assesses children's ability to seek, evaluate, and use health information, including disease prevention and health promotion.
Health Literacy for Adults	Baseline, after 6 weeks, after 12 weeks	Health Literacy Questionnaire (HLS EU-Q16) measures general health literacy in adults, covering access, understanding, and application of health information across various health domains.

Trial Locations

Locations (1)

Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM); 🇩🇪 München, Germany