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临床试验/NCT03695523
NCT03695523已完成不适用

Examining a Childcare Policy to Promote Physical Activity Among Young Children

Western University, Canada2 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2018年9月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
278
试验地点
2
主要终点
Changes in young children's Total Physical Activity (TPA)

研究概览

简要总结

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.

详细描述

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.

研究设计

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

盲法说明

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.

入排标准

年龄范围
1 Year 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

PLAY (PhysicaL ActivitY) Policy Intervention

Experimental

The childcare physical activity policy will be adopted for 8 weeks within participating toddler and preschool classrooms of facilities allocated to the experimental group.

干预措施: PLAY (PhysicaL ActivitY) Policy Intervention (Behavioral)

Control group

No Intervention

Childcare centres will maintain their typical daily programming and standard of care for the duration of the 8-week intervention period.

结局指标

主要结局

Changes in young children's Total Physical Activity (TPA)

时间窗: 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).

次要结局

  • Changes in children's Moderate-to-Vigorous Physical Activity (MVPA)(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.)
  • Changes in children's Sedentary Time (ST)(Measured for 5 consecutive days at baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and at 6-months post-intervention.)
  • Self-efficacy scale for physical activity(Providers will be asked to complete this survey one week prior to baseline measures (Time 1), at baseline (i.e., week 0; Time 2), then again at mid-intervention (i.e., week 4; Time 3), post-intervention (i.e., week 9; Time 4), and at 6 months follow-up.)
  • Environment and Policy Assessment and Observation Self-Report Today (EPAO-SR Today)(Administered to childcare providers in participating classrooms to complete once at baseline (i.e., week 0), mid-intervention (i.e., week 4), post-intervention (i.e., week 9), and at 6-months follow-up.)
  • Policy intervention implementation log(Childcare providers within participating classrooms will be asked to complete the log on three days of each week of the 8-week intervention period.)
  • Director Environment and Policy Assessment and Observation Self-Report (EPAO-SR)(Completed at baseline (i.e., week 0) only.)
  • Feasibility and appropriateness(Conducted post-intervention (after week 9))

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Sponsor

研究点 (2)

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