PLAY (PhysicaL ActivitY) Policy Study

NCT ID: NCT03695523

Last Updated: 2019-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-17

Study Completion Date

2019-06-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Motor Activity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized controlled trial
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PLAY (PhysicaL ActivitY) Policy Intervention

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

Group Type EXPERIMENTAL

PLAY (PhysicaL ActivitY) Policy Intervention

Intervention Type BEHAVIORAL

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).

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PLAY (PhysicaL ActivitY) Policy Intervention

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).

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Examining a childcare policy to promote children's physical activity

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Western University, Canada

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Trish Tucker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Western Ontario, Canada

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Western Ontario - Child Health and Physical Activity Lab

London, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34299917 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

43670

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

111890

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Preschoolers Activity Trial
NCT02293278 COMPLETED NA