Motor ActivityNCT03695523
PLAY (PhysicaL ActivitY) Policy Study
A study testing PLAY (PhysicaL ActivitY) Policy Intervention in people with Motor Activity, run by Western University, Canada at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- What is being tested?
- PLAY (PhysicaL ActivitY) Policy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteCanada
- Study dates
- 17 Sep 2018to 29 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Western Ontario - Child Health and Physical Activity Lab
London, Ontario, N6G 1H1
About this study
Official title: Examining a Childcare Policy to Promote Physical Activity Among Young Children
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.
Read the 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.
- Conditions
- Motor Activity
- Being tested
- PLAY (PhysicaL ActivitY) Policy Intervention
- Keywords
- Physical activity, Children, Child care, Policy, Accelerometer
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLAY (PhysicaL ActivitY) Policy InterventionBehavioural
Also called Examining a childcare policy to promote children's physical activity
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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)
Assessed using ActiGraph wGT3X-BT accelerometers worn on each child's right hip for 5 consecutive days during childcare hours only. Differences in MVPA across groups (control vs. experimental) and over time will be assessed.
Measured: 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)
Assessed using ActiGraph wGT3X-BT accelerometers worn on each child's right hip for 5 days during childcare hours only. Differences between groups (control vs. experimental) and across time will be assessed.
Measured: 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
Developed for the study to assess childcare providers' self-efficacy to engage children in physical activity during hours of care. Providers are instructed to rate their confidence to each of 40 items on a Likert scale from 1 (no confidence at all) to 5 (somewhat confident) to 10 (completely confident). The psychometric properties of the scale will be evaluated, and childcare providers' self-efficacy may be examined as a correlate of children's objectively measured physical activity. Changes in self-efficacy across groups and time will be assessed.
Measured: 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)
Developed and validated by Ward and colleagues (2015), this tool, adapted for use in Canada, without the nutrition scale, provides a snapshot of the daily childcare practices related to physical activity and screen-based sedentary time. Data will be compared across groups (control vs. experimental) and across time (week 0, week 4, week 9, and at 6 months follow-up).
Measured: 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
A self-report log completed by childcare providers in experimental classrooms. Developed for the study to evaluate adherence to the PLAY policy within each classroom.
Measured: 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)
Developed and validated by Ward et al. (2015), this tool, adapted for use in Canada without the nutrition scale, measures each centre's physical space, equipment, environment, and existing physical activity policy and practices as reported by directors. This will be used as a screening tool to indicate any physical activity policies already in effect.
Measured: Completed at baseline (i.e., week 0) only.
Feasibility and appropriateness
Focus groups conducted with experimental group childcare providers will provide feedback on the feasibility and appropriateness of the policy. The challenges and solutions used to overcome these challenges will be discussed. Suggestions for potential modifications and improvements to the policy will be collected to inform future iterations for further investigation with larger, more diverse samples.
Measured: Conducted post-intervention (after week 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start17 Sep 2018
- Primary completion29 Jun 2019
- Study completion29 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trish Tucker, PhD, Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695523
- Sponsor's protocol ID
- 111890
- Other IDs
- 43670
- Status last verified
- Aug 2018
- First submitted
- 18 Sep 2018
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34299917
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining a Childcare Policy to Promote Physical Activity Among Young Children
- ClinicalTrials.gov ID
- NCT03695523
- Acronym / sponsor ID
- 111890
- Conditions
- Motor Activity
- Keywords
- Physical activity, Children, Child care, Policy, Accelerometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 29 Jun 2019 (actual)
- Study completion
- 29 Jun 2019 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| PLAY (PhysicaL ActivitY) Policy Intervention | Experimental | Behavioral: PLAY (PhysicaL ActivitY) Policy InterventionThe childcare physical activity policy will be adopted for 8 weeks within participating toddler and preschool classrooms of facilities allocated to the experimental group. |
| 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. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLAY (PhysicaL ActivitY) Policy InterventionAlso: Examining a childcare policy to promote children's physical activityAn 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). | Behavioural | PLAY (PhysicaL ActivitY) Policy Intervention |
Primary outcome
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).
7 secondary outcomes
Changes in children's Moderate-to-Vigorous Physical Activity (MVPA)
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.
Changes in children's Sedentary Time (ST)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Completed at baseline (i.e., week 0) only.
Feasibility and appropriateness
Time frame: Conducted post-intervention (after week 9)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Derived from this study: PubMed 34299917Szpunar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trish Tucker, PhD principal investigator
University of Western Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLAY (PhysicaL ActivitY) Policy Intervention in people with Motor Activity, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03695523, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019; AzTrials last refreshed its copy on 29 Oct 2026.