PLAY (PhysicaL ActivitY) Policy Study
追踪信息 | |||
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首次提交日期 ICMJE | September 18, 2018 | ||
首次发布日期e ICMJE | October 4, 2018 | ||
最后更新发布日期 | October 4, 2018 | ||
预计研究开始日期 ICMJE | September 17, 2018 | ||
预计主要完成日期 | June 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Changes in young children's Total Physical Activity (TPA)[ Time Frame: Measured for 5 consecutive days at baseline (i.e., week 0), mid-intervention (i.e., week 4), post-intervention (i.e., week 9), and at 6-months post-intervention. ] TPA, the accumulation of light-, moderate-, and vigorous-intensity physical activity will be assessed using ActiGraph wGT3X-BT accelerometers worn on each child's right hip for 5 consecutive days during childcare hours only at 4 time-points. Differences in TPA will be compared across groups (control vs. experimental) and over time (i.e., week 0, week 4, week 9, and 6 months post-intervention). |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | PLAY (PhysicaL ActivitY) Policy Study | ||
正式标题 ICMJE | Examining a Childcare Policy to Promote Physical Activity Among Young Children | ||
简要概况 | This study examines the effectiveness and appropriateness of a written physical activity policy implemented in licensed centre-based childcare on the physical activity levels of toddlers (1-2) and preschoolers (3-5 years). Half of the childcare centres will adopt the physical activity policy while the other half will continue with their typical daily programming and care. It is hypothesized that children enrolled in childcare centres that adopt the policy will display increased levels of physical activity during, and after participating in the policy intervention compared to children enrolled in centres that do not adopt the policy. |
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详细说明 | A pilot, cluster single-blind randomized controlled trial (RCT) will be conducted. Approximately 8 licensed childcare centres will be randomly selected from an online listing of centres in London, Canada. Since it is necessary to implement the policy at the centre-level to groups of children, the childcare centres (i.e., the clusters) rather than the individual participants, will be randomly allocated to either implement the physical activity policy (experimental; n = 4), or maintain their daily programming (control; n = 4) for the 8-week intervention period. In both groups, toddlers' and preschoolers' physical activity will be objectively measured using motion sensors (ActiGraph wGT3X-BT accelerometers) worn on an elastic waistband for 5 consecutive days, during childcare hours, before the policy is implemented (baseline; week 0; September 2018), mid-intervention (week 4; October 2018), one week after the intervention period ends (post-intervention; week 9; November/December 2018), and 6-months post-intervention (May-June 2019). The aim of the study is to examine the impact of a childcare physical activity policy on the objectively measured physical activity levels (light physical activity, LPA; moderate-to-vigorous physical activity, MVPA), and combined total physical activity (TPA), and sedentary time of young children in childcare centres compared to children from centres that maintain their usual standard of care. | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Cluster randomized controlled trial 盲法: Interventional 盲法描述:Children and childcare providers will be aware of whether or not they receive the intervention. However, research assistants who are collecting data will remain blind to each centre's group assignment. 主要目的: Other |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Recruiting | ||
预计入组 ICMJE |
212 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | June 2019 | ||
预计主要完成日期 | June 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: For childcare centres: - Must be a licensed centre-based childcare facility in London, Ontario, Canada or surrounding area - Must provide care to toddlers and/or preschoolers and must have at least one toddler or preschool-age classroom - Must have childcare providers in these classrooms who are willing to participate - Must speak and read English - Must not have an institutional-level physical activity policy in place For childcare providers: - Must be a full-time childcare provider in a toddler or preschool-age classroom of one of the participating centres - Must speak and understand English For toddler/preschool participants: - Must be enrolled in a classroom of a participating centre - Must be between the ages of 1-5 years of age at baseline (and therefore enrolled in their toddler or preschool-age classrooms) - Must be expected to remain in childcare for the next 8 months - Must have a parent/guardian that can read and write English - Must speak and understand English - Must receive parental consent Exclusion Criteria: For childcare centres: - Not be located in London and surrounding area - Not have a toddler or preschool-age classroom - No childcare providers in any classroom who are willing to participate - Not an English-speaking facility - Already has an established physical activity policy in place For childcare providers: - Not full time - Not a childcare provider in a toddler or preschool age classroom at a participating centre - Does not speak/read/write English For toddler/preschooler participants: - Not between the ages of 1 and 5 at baseline - Not expected to remain in childcare for the next 8 months - Not enrolled in toddler or preschool classroom of a participating centre - Does not speak English - Parent/guardian does not read/write in English | ||
性别 |
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年龄 | 最小年龄:1 Year ,最大年龄:5 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Canada | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | , | ||
研究赞助商 ICMJE | Western University, Canada | ||
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研究员 ICMJE |
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PRS 账户 | |||
验证日期 | August 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |