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临床试验/NCT01785498
NCT01785498已完成不适用

Healthy Lifestyles for Children With Complex Heart Problems

Children's Hospital of Eastern Ontario2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Family perception of clinical service

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Family perception of clinical service

时间窗: 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)

时间窗: Within 2 weeks of clinic visit

次要结局

  • Change from Baseline of Children's Self-Perceived Adequacy and Predilection for Physical Activity(1 month after intervention completion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Pat Longmuir

Scientist

Children's Hospital of Eastern Ontario

研究点 (2)

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