NCT03695523

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 18, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2019

Completed
Last Updated

October 23, 2019

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

September 18, 2018

Last Update Submit

October 21, 2019

Conditions

Keywords

Physical activityChildrenChild carePolicyAccelerometer

Outcome Measures

Primary Outcomes (1)

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

    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).

    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 (7)

  • 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.

  • +2 more secondary outcomes

Study Arms (2)

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.

Behavioral: PLAY (PhysicaL ActivitY) Policy Intervention

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.

Interventions

An evidence-based physical activity policy that was developed by researchers and childcare stakeholders and directed by the Canadian 24-Hour Movement Guidelines for the Early Years will be adopted by experimental group childcare centres for 8 weeks. The policy incorporates 8 items (i.e., encouraging children to engage in higher intensity energetic play often, aiming to accumulate 40 minutes each day, exposing children to a variety of indoor and outdoor physical activities, child-directed and teacher-facilitated active play daily, short bouts of outdoor time for a total of 120 minutes each day made up of primarily unstructured free play, encouraging physical literacy by practicing fundamental movement skills, not exposing children to screen-based technology during childcare, and purposefully breaking up sustained sedentary time using physical activities).

Also known as: Examining a childcare policy to promote children's physical activity
PLAY (PhysicaL ActivitY) Policy Intervention

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Western Ontario - Child Health and Physical Activity Lab

London, Ontario, N6G 1H1, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Trish Tucker, PhD

    University of Western Ontario, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2018

First Posted

October 4, 2018

Study Start

September 17, 2018

Primary Completion

June 29, 2019

Study Completion

June 29, 2019

Last Updated

October 23, 2019

Record last verified: 2018-08

Locations