Healthy Lifestyles for Children With Complex Heart Problems (ReACH)

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.

Study Overview

• Status: Completed
• Conditions: Cardiomyopathy; Congenital Heart Defects; Inherited Cardiac Arrhythmias
• Intervention / Treatment: Behavioral: Supplementary resources

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L1
      • Children's Hospital of Eastern Ontario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Receive standard clinical care and supports.
Experimental: Supplementary resources; Receive standard care and supports plus supplementary resources developed for the intervention.	Behavioral: Supplementary resources; Clinical and educational resources for patients, their families and the professionals who care for them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family perception of clinical service	Likert scales to measure family satisfaction with healthy lifestyle information and resources provided during clinic visit.	Within 2 weeks of clinic visit
Pediatric Quality of Life Inventory (PedsQL)		Within 2 weeks of clinic visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline of Children's Self-Perceived Adequacy and Predilection for Physical Activity	1 month after intervention completion

Other Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Multi-dimension anxiety scale for children	1 month after intervention completion
Change from Baseline in Pediatric Symptom Checklist	1 month after intervention completion
Change from Baseline in PedsQL Family Impact Module	1 month after intervention completion

Collaborators and Investigators

• Sponsor: Children's Hospital of Eastern Ontario
• Collaborators: Heart and Stroke Foundation of Ontario; Variety Village; City of Toronto Parks, Forestry and Recreation

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: February 4, 2013
• First Submitted That Met QC Criteria: February 5, 2013
• First Posted (Estimate): February 7, 2013

Study Record Updates

• Last Update Posted (Estimate): February 12, 2015
• Last Update Submitted That Met QC Criteria: February 10, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: physical activity; quality of life; children; healthy lifestyle
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Arrhythmias, Cardiac; Cardiomyopathies; Heart Defects, Congenital
• Other Study ID Numbers: REB12/04X; 2012-06-1-4460033 (Other Grant/Funding Number: Ministry of Health Promotion and Sport Healthy Communities Fund)