Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001206910
Ethics application status
Approved
Date submitted
10/09/2020
Date registered
13/11/2020
Date last updated
27/09/2023
Date data sharing statement initially provided
13/11/2020
Date results provided
4/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an evidence-informed physical activity policy for early childhood education and care (ECEC) services in Western Australia.
Scientific title
A pragmatic randomised controlled trial of the impact of an evidence-informed physical activity policy in Western Australian early childhood education and care (ECEC) services.
Secondary ID [1] 299180 0
NHMRC Partnership Grant GNT1152086
Universal Trial Number (UTN)
Trial acronym
PPP (PLAYCE Policy Project)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 317873 0
Condition category
Condition code
Public Health 312628 312628 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Play Active program intervention involves providing ECEC services with a copy of a previously developed and tested evidence-informed physical activity policy template (“Play Active Early Childhood Education and Care Physical Activity Policy”).This will occur after baseline data collection has been completed. ECEC service staff (centre director and educators within centre) will personalise the policy so it is adapted to the suit the needs of their centre and attending children and families. This will occur over a two month period and is important for ownership and implementation of the policy.

Once adapted, the physical activity policy is submitted for review and approval by the research team to ensure minimum criteria are met. The minimum criteria are for the policy to include: two (out of two) key statements; nine (out of nine) recommendations; and at least five (out of 25) procedural strategies. Once approved, the policy implementation period will run for three months. At the commencement of the three month implementation period ECEC services will be provided with a supporting informational resource guide (hard copy and digital) with practical tips on implementing their physical activity policy into practice as well as online access to free professional development training for educators provided by a partner organisation. The professional development training focusses on developing children’s fundamental movement skills and improving physical activity levels. This will involve six, 30-60 minute online training modules which educators can complete at their own pace over the three month implementation period.

Intervention fidelity will be measured via an educator survey (and observation) to determine the degree to which strategies included in the physical activity policy are being implemented as intended as well as the use and utility of the implementation supports (i.e., resource guide and professional development training).

To improve fidelity within the relatively short three month implementation period, ECECs will be provided with information on strategies in the physical activity policy which are likely to have high impact and require less effort. ECEC’s will identify which high impact, low effort strategies they will focus on during the three month implementation period.
Intervention code [1] 315477 0
Prevention
Intervention code [2] 315479 0
Lifestyle
Intervention code [3] 317829 0
Behaviour
Comparator / control treatment
No treatment, usual care – ECEC services will be waitlisted and instructed to continue their usual practices around play and physical activity. After the conclusion of the trial they will receive the intervention.
Control group
Active

Outcomes
Primary outcome [1] 321287 0
Change in educator physical activity practices composite score as assessed using items from the validated Nutrition and Physical Activity Self-Assessment for Child Care (NAPSACC) and Environment and Policy Assessment and Observation (EPAO) instruments.
Timepoint [1] 321287 0
Baseline, 3 months after policy implementation period, 9 months after policy implementation period
Secondary outcome [1] 383833 0
Change in children’s observed active play as measured by the brief, validated Active Play Assessment Tool (APAT).
Timepoint [1] 383833 0
Baseline, 3 months after policy implementation period, 9 months after policy implementation period
Secondary outcome [2] 386807 0
Change in children’s physical activity as objectively measured using accelerometry
Timepoint [2] 386807 0
Baseline, 3 months after policy implementation period, 9 months after policy implementation period

Eligibility
Key inclusion criteria
All long-day ECEC services located in the Perth metropolitan area of WA are eligible for inclusion.

Within each ECEC service, all permanent part- and full-time staff educators are eligible for participation in the study.

Within each ECEC service, all attending children aged 1-5 years who have not yet commenced formal schooling (pre-primary) will be eligible for participation in the study with parental consent.
Minimum age
18 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Long-day ECEC services catering exclusively for children requiring specialist care, mobile preschools, and Department of Education and Communities preschools will be ineligible for the study. ECEC services that have had a significant change in management within the last three months or expect a change in management the next three months will also be excluded. ECEC services already involved in an alternative randomised controlled trial currently underway in Perth, Western Australia will be excluded.

Within each ECEC service, casually employed staff educators are ineligible for participation in the study.

Exclusion criteria for attending children are a recognized disability (physical, emotional/behavioural or intellectual) that would affect participation in physical activity, and attendance of full-time formal schooling which would prohibit whole days spent in ECEC.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2020
Actual
28/04/2021
Date of last participant enrolment
Anticipated
Actual
17/03/2022
Date of last data collection
Anticipated
Actual
17/03/2022
Sample size
Target
309
Accrual to date
Final
675
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 303722 0
Government body
Name [1] 303722 0
National Health and Medical Research Council
Country [1] 303722 0
Australia
Funding source category [2] 304971 0
Charities/Societies/Foundations
Name [2] 304971 0
Cancer Council WA
Country [2] 304971 0
Australia
Funding source category [3] 304972 0
Government body
Name [3] 304972 0
WA Department of Health
Country [3] 304972 0
Australia
Funding source category [4] 304973 0
Charities/Societies/Foundations
Name [4] 304973 0
Nature Play Australia
Country [4] 304973 0
Australia
Funding source category [5] 304974 0
Charities/Societies/Foundations
Name [5] 304974 0
Australian Childcare Alliance
Country [5] 304974 0
Australia
Funding source category [6] 304975 0
Charities/Societies/Foundations
Name [6] 304975 0
Goodstart Early Learning Ltd
Country [6] 304975 0
Australia
Funding source category [7] 304976 0
Government body
Name [7] 304976 0
WA Department of Local Government, Sport and Cultural Industries
Country [7] 304976 0
Australia
Funding source category [8] 304977 0
Charities/Societies/Foundations
Name [8] 304977 0
Minderoo Foundation
Country [8] 304977 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Hayley Christian
Address
Telethon Kids Institute
15 Hospital Ave
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 305331 0
None
Name [1] 305331 0
Address [1] 305331 0
Country [1] 305331 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304247 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 304247 0
Ethics committee country [1] 304247 0
Australia
Date submitted for ethics approval [1] 304247 0
Approval date [1] 304247 0
19/05/2020
Ethics approval number [1] 304247 0
RA/4/20/6120

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96274 0
A/Prof Hayley Christian
Address 96274 0
Telethon Kids Institute 15 Hospital Ave Nedlands WA 6009
Country 96274 0
Australia
Phone 96274 0
+61 8 6319 1040
Fax 96274 0
Email 96274 0
[email protected]
Contact person for public queries
Name 96275 0
Phoebe George
Address 96275 0
Telethon Kids Institute 15 Hospital Ave Nedlands WA 6009
Country 96275 0
Australia
Phone 96275 0
+61 8 6319 1489
Fax 96275 0
Email 96275 0
[email protected]
Contact person for scientific queries
Name 96276 0
Hayley Christian
Address 96276 0
Telethon Kids Institute 15 Hospital Ave Nedlands WA 6009
Country 96276 0
Australia
Phone 96276 0
+61 8 6319 1040
Fax 96276 0
Email 96276 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Academics and research staff

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified full dataset

What types of analyses could be done with individual participant data?
• Any purpose approved by the Principal Investigator and relevant ethics committees.

When can requests for individual participant data be made (start and end dates)?
From:
Available from 12 months after anticipated project end date, with no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Please contact the Principal Investigator via email on [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4549Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.