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Healthy Lifestyles for Children With Complex Heart Problems (ReACH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Children's Hospital of Eastern Ontario
Sponsor:
Collaborators:
Variety Village
Heart and Stroke Foundation of Ontario
City of Toronto Parks, Forestry and Recreation
Information provided by (Responsible Party):
Dr. Pat Longmuir, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT01785498
First received: February 4, 2013
Last updated: February 5, 2013
Last verified: February 2013

February 4, 2013
February 5, 2013
January 2012
June 2013   (final data collection date for primary outcome measure)
  • Family perception of clinical service [ Time Frame: Within 2 weeks of clinic visit ] [ Designated as safety issue: No ]
    Likert scales to measure family satisfaction with healthy lifestyle information and resources provided during clinic visit.
  • Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: Within 2 weeks of clinic visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01785498 on ClinicalTrials.gov Archive Site
Change from Baseline of Children's Self-Perceived Adequacy and Predilection for Physical Activity [ Time Frame: 1 month after intervention completion ] [ Designated as safety issue: No ]
Same as current
  • Change from Baseline in Multi-dimension anxiety scale for children [ Time Frame: 1 month after intervention completion ] [ Designated as safety issue: No ]
  • Change from Baseline in Pediatric Symptom Checklist [ Time Frame: 1 month after intervention completion ] [ Designated as safety issue: No ]
  • Change from Baseline in PedsQL Family Impact Module [ Time Frame: 1 month after intervention completion ] [ Designated as safety issue: No ]
Same as current
 
Healthy Lifestyles for Children With Complex Heart Problems
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Congenital Heart Defects
  • Inherited Cardiac Arrhythmias
  • Cardiomyopathy
Behavioral: Supplementary resources
Clinical and educational resources for patients, their families and the professionals who care for them.
  • 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.
    Intervention: Behavioral: Supplementary resources
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
August 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
4 Years to 17 Years
No
Contact: Pat Longmuir, PhD 6137383908 plongmuir@cheo.on.ca
Canada
 
NCT01785498
REB12/04X, 2012-06-1-4460033
No
Dr. Pat Longmuir, Children's Hospital of Eastern Ontario
Children's Hospital of Eastern Ontario
  • Variety Village
  • Heart and Stroke Foundation of Ontario
  • City of Toronto Parks, Forestry and Recreation
Not Provided
Children's Hospital of Eastern Ontario
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP