PLAY (PhysicaL ActivitY) Policy Study
Tracking Information | |||
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First Submitted Date ICMJE | September 18, 2018 | ||
First Posted Date ICMJE | October 4, 2018 | ||
Last Update Posted Date | October 4, 2018 | ||
Actual Study Start Date ICMJE | September 17, 2018 | ||
Estimated Primary Completion Date | June 2019 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures 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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Original Primary Outcome Measures ICMJE | Same as current | ||
Current Secondary Outcome Measures ICMJE |
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Descriptive Information | |||
Brief Title ICMJE | PLAY (PhysicaL ActivitY) Policy Study |
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Official Title ICMJE | Examining a Childcare Policy to Promote Physical Activity Among Young Children |
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Brief Summary | 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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Detailed Description | 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. | ||
Study Type ICMJE | Interventional | ||
Study Phase | N/A | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Cluster randomized controlled trial Masking: Interventional Masking Description: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. Primary Purpose: Other |
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Condition ICMJE | |||
Intervention ICMJE |
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Study Arms |
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Recruitment Information | |||
Recruitment Status ICMJE | Recruiting | ||
Estimated Enrollment ICMJE |
212 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Estimated Study Completion Date | June 2019 | ||
Estimated Primary Completion Date | June 2019 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria 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 | ||
Sex/Gender |
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Ages | 1 Year and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers | No | ||
Listed Location Countries ICMJE | Canada | ||
Removed Location Countries | |||
Administrative Information | Has Data Monitoring Committee | No | |
U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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IPD Sharing Statement |
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Responsible Party | , | ||
Study Sponsor ICMJE | Western University, Canada | ||
Collaborators ICMJE | |||
Investigators ICMJE |
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PRS Account | |||
Verification Date | August 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |