Healthy Lifestyles for Children With Complex Heart Problems

NCT ID: NCT01785498

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-10-31

Brief Summary

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.

Conditions

Congenital Heart Defects; Inherited Cardiac Arrhythmias; Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control Group

Receive standard clinical care and supports.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Supplementary resources

Receive standard care and supports plus supplementary resources developed for the intervention.

Group Type: EXPERIMENTAL

Supplementary resources

Intervention Type: BEHAVIORAL

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

Interventions

Supplementary resources

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Variety Village

UNKNOWN

Sponsor Role: collaborator

Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role: collaborator

City of Toronto Parks, Forestry and Recreation

UNKNOWN

Sponsor Role: collaborator

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role: lead

Responsible Party

Dr. Pat Longmuir

Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

2012-06-1-4460033

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

REB12/04X

Identifier Type: -

Identifier Source: org_study_id