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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Digital Health Nudging in Adolescents With Congenital Heart Disease

NCT04933786

Congenital Heart Disease

COMPLETED NA

Web-based Motor Intervention to Increase Health Related Physical Fitness in Children With Congenital Heart Disease

NCT03488797

Congenital Heart Disease Health Related Physical Fitness Motor Skills +1 more

COMPLETED NA

Digital Cardiovascular Health Promotion Among School-going Adolescents in Nepal

NCT06668675

Heart Disease

COMPLETED NA

Wearable Technology for Personalised Physical Activity Feedback in Cardiac Patients: a Feasibility Study

NCT05605015

Cardiovascular Diseases

COMPLETED EARLY_PHASE1

Start-to-Sport - Home-based Exercise for Adolescents and Adults With Congenital Heart Disease

NCT02240147

Congenital Heart Defect

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Heart Disease Pediatric ALL

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study uses a delayed start design with two arms. In Arm 1, participants receive the intervention immediately for 12 weeks. In Arm 2, participants initially do not receive the intervention but will start the same intervention after a 12-week delay to ensure fairness.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Digital Health Intervention

Intervention Type BEHAVIORAL

Access to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digital Health Intervention

Access to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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