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

January 27, 2025 updated by: Deutsches Herzzentrum Muenchen

Digital Lifestyle Intervention to Promote Physical Activity, Nutrition, and Health Literacy in Children With Congenital Heart Disease and Their Guardians

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • München, Germany
        • Recruiting
        • Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Digital Health Intervention
Access to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily step count
Time Frame: 12 weeks
Children's daily step count is objectively assessed using the wrist-worn wearable device, Garmin Vivofit Jr. 2.
12 weeks
Health-related quality of life
Time Frame: 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.
Baseline, after 6 weeks, after 12 weeks
Physical Activity Health Literacy
Time Frame: 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.
Baseline, after 6 weeks, after 12 weeks
Nutritional Health Literacy
Time Frame: 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.
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
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.
Baseline, after 6 weeks, after 12 weeks
Health Literacy for Children
Time Frame: 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.
Baseline, after 6 weeks, after 12 weeks
Health Literacy for Adults
Time Frame: 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.
Baseline, after 6 weeks, after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

Technical University of Munich
Stiftung KinderHerz Deutschland gGmbH

Investigators

  • Principal Investigator: Jan Müller, Prof. Dr., Technical University of Munich, Chair of preventive perdiatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

October 2, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-337-S-SB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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