Clinical trial NCT03695523: PLAY (PhysicaL ActivitY) Policy Study
Official title: Examining a Childcare Policy to Promote Physical Activity Among Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Activity
Keywords: Physical activity
Children
Child care
Policy
Accelerometer
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 278
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in young children's Total Physical Activity (TPA)
timeFrame: 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.
Secondary outcomes:
measure: Changes in children's Moderate-to-Vigorous Physical Activity (MVPA)
timeFrame: 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.
measure: Changes in children's Sedentary Time (ST)
timeFrame: Measured for 5 consecutive days at baseline (week 0), mid-intervention (week 4), post-intervention (week 9), and at 6-months post-intervention.
measure: Self-efficacy scale for physical activity
timeFrame: 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.
measure: Environment and Policy Assessment and Observation Self-Report Today (EPAO-SR Today)
timeFrame: 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.
measure: Policy intervention implementation log
timeFrame: Childcare providers within participating classrooms will be asked to complete the log on three days of each week of the 8-week intervention period.
measure: Director Environment and Policy Assessment and Observation Self-Report (EPAO-SR)
timeFrame: Completed at baseline (i.e., week 0) only.
measure: Feasibility and appropriateness
timeFrame: Conducted post-intervention (after week 9)
Other outcomes:
Locations:
city: London
country: Canada
facility: University of Western Ontario - Child Health and Physical Activity Lab
state: Ontario
Study officials:
affiliation: University of Western Ontario, Canada
name: Trish Tucker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szpunar M, Driediger M, Johnson AM, Vanderloo LM, Burke SM, Irwin JD, Shelley J, Timmons BW, Tucker P. Impact of the Childcare Physical Activity (PLAY) Policy on Young Children's Physical Activity and Sedentary Time: A Pilot Clustered Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jul 13;18(14):7468. doi: 10.3390/ijerph18147468.