SCORE! ACTIVE: Advancing Codesigned Health Promotion and Physical Activity Interventions to Improve Self-Efficacy and Health: A Stepped Wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale
研究概览
简要总结
Hamilton is a city with a growing newcomer population. Families who are new to Canada do not always have the same resources to access healthy active living (HAL) activities as compared to Canadian-born families. The SCORE! ACTIVE trial will recruit newcomer families with young children in Hamilton and help provide them with access to HAL activities. Through this, the investigators want to see if newcomer children's perspectives of physical activity will change over time. They will also see if increasing newcomer children's access to these resources will promote an increase in HAL behaviours.
详细描述
The investigators will conduct a pragmatic, stepped-wedge cluster randomized trial in 14 neighbourhoods to determine the impact of SCORE! ACTIVE trial on the primary outcome of PA self-efficacy among 5-11-year-old children. The SW-CRT involves the sequential transition of clusters, in this case neighbourhoods, from control to intervention conditions in a randomized order. In this case, the method is pragmatic because recruitment and initial baseline measures in each community will occur just before the initiation of the intervention. There have been methodological challenges noted with SW-CRT including identification and recruitment bias, within cluster bias, and secular trends. However, this design is ideal for the implementation of the SCORE! ACTIVE trial because for practical reasons, it is not possible to deliver the intervention to many clusters at the same time. The trial will be reported using CONSORT guidelines and extension of SW-CRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newcomer families (those who have been in Canada for 10 years or less) with at least 1 child aged 5 up to 11 (11.99 years) living in a Hamilton, Ontario.
- •At least one parent/guardian born outside of Canada and residing in Canada ≤ 10 years.
- •Families must be living in one of the designated neighbourhood clusters
排除标准
- •Children participating in organized physical activity programs for 3 or more times per week
- •Families with involvement with child protection services and/or foster care
研究组 & 干预措施
SCORE! ACTIVE
This is the only arm of the study. The interventions included in this arm are physical activity programming (SCORE! CLUB), navigator services (SCORE! navigator), and health promotion messaging. All clusters will receive this intervention.
干预措施: Physical activity program (Other)
SCORE! ACTIVE
This is the only arm of the study. The interventions included in this arm are physical activity programming (SCORE! CLUB), navigator services (SCORE! navigator), and health promotion messaging. All clusters will receive this intervention.
干预措施: Navigation (Other)
SCORE! ACTIVE
This is the only arm of the study. The interventions included in this arm are physical activity programming (SCORE! CLUB), navigator services (SCORE! navigator), and health promotion messaging. All clusters will receive this intervention.
干预措施: Health promotion (Other)
结局指标
主要结局
Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale
时间窗: Baseline to 6 months
Using CSAPPA, a 19-item scale that measures how children feel about their physical activity skills and their likelihood of choosing physical activities, a change in children's physical activity self-efficacy will be measured at 6 months as the primary outcome.
次要结局
- Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale(12 months from baseline; 18 months from baseline)
- Physical Activity & Sedentary Behavior Questionnaire(Baseline to 18 months)
研究者
Gita Wahi
Associate Professor, Pediatrics
Hamilton Health Sciences Corporation