Healthy Lifestyles for Children With Complex Heart Problems (ReACH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01785498|
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : February 12, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Defects Inherited Cardiac Arrhythmias Cardiomyopathy||Behavioral: Supplementary resources||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Healthy Lifestyles for Children With Complex Heart Problems|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||October 2013|
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.
- 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.
- Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: Within 2 weeks of clinic visit ]
- Change from Baseline of Children's Self-Perceived Adequacy and Predilection for Physical Activity [ Time Frame: 1 month after intervention completion ]
- Change from Baseline in Multi-dimension anxiety scale for children [ Time Frame: 1 month after intervention completion ]
- Change from Baseline in Pediatric Symptom Checklist [ Time Frame: 1 month after intervention completion ]
- Change from Baseline in PedsQL Family Impact Module [ Time Frame: 1 month after intervention completion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785498
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H 8L1|