Skip to main content
OpenTrials
Completed

NCT Number: NCT01785498

Healthy Lifestyles for Children With Complex Heart Problems

Healthy Lifestyles for Children with Complex Heart Problems is a planning and resource development project. The goal of the project is to develop an implementation plan that would enable children with complex heart problems to lead healthy, active lives within their own community. The primary goal of the project is to promote physical activity, because the physical and mental health benefits of activity are very important for these children. Children with complex heart problems have a higher risk for obesity, diabetes, acquired heart disease and mental health problems than their healthy peers. The physical health benefits of physical activity are well known, but physical activity is also key for children's mental health. Physical activity enables children to socialize with peers and create bonds and friendships. Physical activity participation also directly elevates mood through the release of brain chemicals. Children with complex heart problems are also known to experience fear and anxiety related to physical activity. This project will also develop strategies to promote healthy eating and the prevention of physical activity-related injuries to these children and their families. Children with complex heart problems are at higher risk of overweight and obesity and face unique injury risks related to pacemakers or their medications.

Extensive consultations with families and caregivers have identified needed supports for physical activity lifestyles, mental health, healthy eating and injury prevention for these children. The goal of the interviews was to understand the positive and negative influences on physical activity and healthy lifestyles for these children. Analyses of the interview content was used to develop a detailed, step-by-step implementation plan to provide the supports necessary for children with complex heart problems to lead active, healthy lives in their own community, with their family and friends. The implementation plan specifies changes to family education and counselling resources, clinical care routines, and communication among professionals and families.

The clinical trial will evaluate the impact of implementing the family supports and changes to practice previously developed. Surveys will be completed by families attending the cardiac clinic before and after the changes to practice and additional resources are made available. Interviews will be utilized to gather additional feedback from professionals and families that receive counselling utilizing the supplementary materials.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • child with a heart condition requiring on-going follow up between 4 and 17 years of age or parent or healthcare provider of such a child
  • able to verbally answer questions and express opinions in English or French
  • able to provide informed consent or assent to participate

Exclusion criteria

  • disability other than heart condition which significantly impacts physical activity participation or healthy lifestyle habits

Treatment and study plan

Supplementary resources

Behavioral

Clinical and educational resources for patients, their families and the professionals who care for them.

Primary outcomes

  1. Family perception of clinical service

    Time frame: Within 2 weeks of clinic visit

    Likert scales to measure family satisfaction with healthy lifestyle information and resources provided during clinic visit.

  2. Pediatric Quality of Life Inventory (PedsQL)

    Time frame: Within 2 weeks of clinic visit

Secondary outcomes

  1. Change from Baseline of Children's Self-Perceived Adequacy and Predilection for Physical Activity

    Time frame: 1 month after intervention completion

Other outcomes

  1. Change from Baseline in Multi-dimension anxiety scale for children

    Time frame: 1 month after intervention completion

  2. Change from Baseline in Pediatric Symptom Checklist

    Time frame: 1 month after intervention completion

  3. Change from Baseline in PedsQL Family Impact Module

    Time frame: 1 month after intervention completion

Sponsors and collaborators

Lead sponsor

Children's Hospital of Eastern Ontario

Other

Collaborators

  • City of Toronto Parks, Forestry and Recreation
  • Heart and Stroke Foundation of Ontario
  • Variety Village

Registry information

Acronym: ReACH

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 7, 2013
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.