Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000406505
Ethics application status
Approved
Date submitted
27/02/2024
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of scaling up the Play Active program for children’s physical activity in Australian early childhood education and care services
Scientific title
Scaling-up the ‘Play Active’ program to support children’s physical activity in early childhood education and care — a multi-state type III hybrid effectiveness-implementation trial
Secondary ID [1] 310426 0
Medical Research Future Fund MRFF: APP2022912
Secondary ID [2] 311619 0
Healthway: 34818
Secondary ID [3] 311620 0
Australian Research Council Centre of Excellence for Children and Families over the Life Course: CE200100025
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is linked to registration record ACTRN12620001206910. The existing registration record was a pragmatic cluster randomised trial of the Play Active intervention in Perth, Western Australia. The current study is a multi-state (WA, SA, QLD) type III hybrid effectiveness-implementation trial - a scale up of the Play Active intervention.

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 331192 0
Condition category
Condition code
Public Health 327968 327968 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The central component of Play Active is an evidence-informed physical activity policy template for early childhood education and care (ECEC) services. Services are supported to implement the policy through implementation support strategies.

The Play Active Policy: The policy contains 25 procedures that ECEC service directors select to support their service to achieve nine age-specific physical activity and sedentary behaviour recommendations and two key statements. The recommendations and key statements provide clear guidance on the amount of physical activity and sedentary time, including screen time, children should be engaged in while attending ECEC. For example:
- To meet the Australian 24-Hour Movement Guidelines for the Early Years, provide children with at least 180 minutes of physical activity daily, via a variety of physical activities spread throughout the day.
- Sedentary screen time for purposes other than learning will not be allowed.

Play Active implementation support strategies: The majority of the implementation support will be delivered to ECEC service directors via a dedicated Play Active website involving: (i) Self-assessment of current physical activity procedure implementation; (ii) Tailoring of their Play Active policy based on their self-assessment in step (i); (iii)Professional development ; (iv) Becoming a member; (v) Accessing member benefits and inviting educators to complete Play Active professional development.

Member benefits include a printed membership pack containing their Play Active policy, a Resource Guide supporting each of the procedures, prompts and suggestions for action to help with policy implementation, communities of practice, feedback and resources.

The implementation support strategies include:
• Tailoring of ECEC service Play Active policy (the Play Active website supports services to create a tailored Play Active policy, informed by their current implementation of the 25 policy procedures via self-assessment);
• Professional Development (brief online modules through the Play Active website);
• Tailored prompts & positive reinforcement (emails and SMS to prompt directors and educators to complete the 5-step (directors) and 3-step (educators) process to join Play Active);
• Survey & feedback reports (self-assessments every 12 months to monitor progress and provide feedback - delivered by the Play Active website);
• Membership fee to increase buy-in and the real-world relevance of the trial ($200 membership fee for 2 years);
• Resources (printed Resource Guide providing information on why each policy procedure is important and how to achieve each procedure);
• Community of practice (member only website dashboard, live webinars, Play Active member newsletter, social media to enable sharing of case studies between educators and directors, webinars);
• Parent resources (e.g., e-news with tips for active play at home);
• Member renewal (after two years, services can renew their membership through the Play Active website for a $100-200 fee and by completing further professional development);
• Branding & partnerships (Play Active brand and partnerships to increase reputation, recruitment and retention);
• Increase demand - a recruitment strategy providing additional opportunities for new services to register e.g., direct mailout, paid social media advertising);
• Co-design (Investigator Advisory Group, Partner Advisory Group & Consumer Advisory Group).

The duration of the Play Active intervention is 30 months. All components of the intervention will be available at the start (after ECEC directors complete the 60 minute process on the Play Active website). Dose of implementation support provided (fidelity) will be collected through the Play Active website. Modifications to the implementation support provided will be tracked throughout the trial using the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) and FRAME-IS for implementation support strategies. Process evaluation will include reach (i.e., number of educators and directors registering); adoption (i.e., number of services becoming members); engagement (i.e., website, email and SMS usage analytics and user experience); and acceptability, appropriateness and feasibility – including implementation barriers and facilitators. Process evaluation data collection will include surveys with educators and directors and semi-structured interviews with directors and educators.
Intervention code [1] 326822 0
Prevention
Intervention code [2] 328078 0
Lifestyle
Intervention code [3] 328079 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335819 0
Implementation outcome: Change in ECEC staff Play Active practice adoption will be assessed using a director-reported instrument previously developed and validated by the research team.
Timepoint [1] 335819 0
Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline (primary endpoint)
Secondary outcome [1] 432212 0
Effectiveness outcome (ii): Change in children’s daily physical activity at ECEC objectively measured using accelerometry, in a sub-sample of 30 services (n=10 each in WA, QLD and SA).
Timepoint [1] 432212 0
Baseline
12 months after baseline
Secondary outcome [2] 432213 0
Sustainability outcome: Sustainability will be assessed based on the number of ECEC services that renew their membership at 24 months. Sustainability of policy practice implementation will be assessed using the same items in the primary outcome at 30 months.
Timepoint [2] 432213 0
24 months after baseline
30 months after baseline
Secondary outcome [3] 432215 0
Cost-effectiveness outcome: The cost-effectiveness outcome will use educator-reported additional minutes of children’s ECEC-based daily physical activity at 12- and 24-month follow-up, from baseline. Resource use associated with the development and implementation of the intervention, including ECEC, Project Officer time, and other relevant resources, will be measured and valued using appropriate unit-costs provided by the Play Active Partner Advisory Group. Costs will be adjusted for inflation, and both outcomes and costs will be discounted as per best practice. The effectiveness and cost measures will be used to generate incremental cost-effectiveness ratio (ICER), with the main ICER being the cost per additional minute of physical activity per day at ECEC.
Timepoint [3] 432215 0
12 months after baseline
24 months after baseline
Secondary outcome [4] 432218 0
Process evaluation outcome from Directors and Educators
Assessment method – Participant reflections on implementing Play Active (including any facilitators or barriers experienced) will be discussed through semi-structured interviews with a subsample of ECEC service directors (n=20) and staff (n=20).
Timepoint [4] 432218 0
18 months after baseline
Secondary outcome [5] 433027 0
Effectiveness outcome (i), item 1: The amount of time children are provided for indoor physical activity each day
Assessment method: educator-reported instrument (Play Active website survey)
Timepoint [5] 433027 0
Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
Secondary outcome [6] 433028 0
Effectiveness outcome (i), item 2: The amount of time children are provided for outdoor physical activity each day
Assessment method: educator-reported instrument (Play Active website survey)
Timepoint [6] 433028 0
Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
Secondary outcome [7] 433029 0
Effectiveness outcome (i), item 3: The amount of educator led physical activity children are provided with each day
Assessment method: educator-reported instrument (Play Active website survey)
Timepoint [7] 433029 0
Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
Secondary outcome [8] 433030 0
Effectiveness outcome (i), item 4: The amount of time children are provided with for energetic play each day
Assessment method: educator-reported instrument (Play Active website survey)
Timepoint [8] 433030 0
Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
Secondary outcome [9] 433031 0
Effectiveness outcome (i), item 5: Outside of sleep and mealtimes, the longest amount of time children are expected to remain seated (e.g. in seats, strollers, swings) at any one time
Assessment method: educator-reported instrument (Play Active website survey)
Timepoint [9] 433031 0
Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
Secondary outcome [10] 433032 0
Effectiveness outcome (i), item 6: The amount of screen time provided each day to children
Assessment method: educator-reported instrument (Play Active website survey)
Timepoint [10] 433032 0
Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
Secondary outcome [11] 433033 0
Effectiveness outcome (i), item 7: Frequency of use of cots, car seats and highchairs for their primary purpose only (i.e. cots for sleeping, car seats for vehicle travel, and highchairs for eating)
Assessment method: educator-reported instrument (Play Active website survey)
Timepoint [11] 433033 0
Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
Secondary outcome [12] 433034 0
Effectiveness outcome (i), item 8: Total time non-mobile infants provided with tummy time each day
Assessment method: educator-reported instrument (Play Active website survey)
Timepoint [12] 433034 0
Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
Secondary outcome [13] 433035 0
Effectiveness outcome (i), item 9: Number of times non-mobile infants are placed on their tummy for play
Assessment method: educator-reported instrument (Play Active website survey)
Timepoint [13] 433035 0
Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
Secondary outcome [14] 433036 0
Dissemination (recruitment) outcome 1: Number of services registered
Assessment method: Website analytics
Timepoint [14] 433036 0
2 months after baseline
4 months after baseline
6 months after baseline
Secondary outcome [15] 433037 0
Dissemination (recruitment) outcome 2: Number of services becoming Play Active members
Assessment method: Website analytics
Timepoint [15] 433037 0
6 months after baseline
Secondary outcome [16] 433038 0
Dissemination (recruitment) outcome 3: Number of services renewing membership
Assessment method: Website analytics
Timepoint [16] 433038 0
30 months after baseline
Secondary outcome [17] 433039 0
Dissemination (recruitment) outcome 4: Most effective dissemination strategy
Assessment method: 1-item pop up survey will be included on the website asking which dissemination strategy led to ECEC services registering (e.g., Play Active Launch Event, e-flyer, Play Active Facebook Page, Other)
Timepoint [17] 433039 0
2 months after baseline
4 months after baseline
6 months after baseline
Secondary outcome [18] 433040 0
Process evaluation outcome - reach: The number and geographic spread of ECEC services registering at least one staff member
Assessment method: Website analytics
Timepoint [18] 433040 0
Each 6 months after baseline
Secondary outcome [19] 433041 0
Process evaluation outcome - adoption: The number and geographic spread of ECEC services purchasing membership
Assessment method: Website analytics
Timepoint [19] 433041 0
Each 6 months after baseline
Secondary outcome [20] 433042 0
Process evaluation outcome - engagement (i): The number and geographic spread of ECEC services using the website: unique sessions, page views, average session duration and resource downloads
Assessment method: Website analytics
Timepoint [20] 433042 0
Each 6 months after baseline
Secondary outcome [21] 433043 0
Process evaluation outcome - engagement (ii): The number and geographic spread of ECEC services using SMS and email prompts
Assessment method: Website analytics
Timepoint [21] 433043 0
Each 6 months after baseline
Secondary outcome [22] 433044 0
Process evaluation outcome - acceptability: ECEC staff self-reported acceptability
Assessment method: Play Active website survey
Timepoint [22] 433044 0
6 months after baseline
Secondary outcome [23] 433045 0
Process evaluation outcome - appropriateness: ECEC staff self-reported appropriateness
Assessment method: Play Active website survey
Timepoint [23] 433045 0
6 months after baseline
Secondary outcome [24] 433046 0
Process evaluation outcome - feasibility ECEC staff self-reported feasibility
Assessment method: Play Active website survey
Timepoint [24] 433046 0
6 months after baseline

Eligibility
Key inclusion criteria
All long-daycare ECEC services in WA, SA and QLD Australia are eligible for inclusion.

Within each ECEC service, all directors and educators are eligible to participate. There is no limit on minimum age as directors and educators will report on infants, defined as 0-1 year old.

Within a sub-sample of 30 ECEC services, all attending children aged 2-5 years who have not yet commenced formal schooling will be eligible to participate in the accelerometer sub-sample data collection with parental consent.
Minimum age
No limit
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 government-operated preschools will be ineligible for the study.

Exclusion criteria for attending children with 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
30/04/2027
Actual
Sample size
Target
741
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA

Funding & Sponsors
Funding source category [1] 314634 0
Government body
Name [1] 314634 0
Medical Research Future Fund
Country [1] 314634 0
Australia
Funding source category [2] 315928 0
Government body
Name [2] 315928 0
Healthway
Country [2] 315928 0
Australia
Funding source category [3] 315929 0
Government body
Name [3] 315929 0
Australian Research Council Centre of Excellence for Children and Families over the Life Course (Life Course Centre)
Country [3] 315929 0
Australia
Funding source category [4] 315930 0
Charities/Societies/Foundations
Name [4] 315930 0
Cancer Council WA
Country [4] 315930 0
Australia
Funding source category [5] 315931 0
Charities/Societies/Foundations
Name [5] 315931 0
YMCA WA
Country [5] 315931 0
Australia
Funding source category [6] 315932 0
Charities/Societies/Foundations
Name [6] 315932 0
Australian Childcare Alliance WA
Country [6] 315932 0
Australia
Funding source category [7] 315933 0
Charities/Societies/Foundations
Name [7] 315933 0
Play Matters Collective
Country [7] 315933 0
Australia
Funding source category [8] 315934 0
Government body
Name [8] 315934 0
Department of Local Government, Sport and Cultural Industries, Western Australia
Country [8] 315934 0
Australia
Funding source category [9] 315935 0
Charities/Societies/Foundations
Name [9] 315935 0
Early Childhood Australia
Country [9] 315935 0
Australia
Funding source category [10] 315936 0
Government body
Name [10] 315936 0
Health and Wellbeing Queensland
Country [10] 315936 0
Australia
Funding source category [11] 315937 0
Charities/Societies/Foundations
Name [11] 315937 0
Australian Childcare Alliance SA
Country [11] 315937 0
Australia
Funding source category [12] 315938 0
Charities/Societies/Foundations
Name [12] 315938 0
Goodstart Early Learning
Country [12] 315938 0
Australia
Funding source category [13] 315939 0
Charities/Societies/Foundations
Name [13] 315939 0
Early Childhood Australia WA
Country [13] 315939 0
Australia
Funding source category [14] 315940 0
Charities/Societies/Foundations
Name [14] 315940 0
Play Australia
Country [14] 315940 0
Australia
Funding source category [15] 315941 0
Charities/Societies/Foundations
Name [15] 315941 0
Nature Play Australia
Country [15] 315941 0
Australia
Funding source category [16] 315942 0
Charities/Societies/Foundations
Name [16] 315942 0
Australian Childcare Alliance QLD
Country [16] 315942 0
Australia
Funding source category [17] 315943 0
Commercial sector/Industry
Name [17] 315943 0
Sonas Childcare
Country [17] 315943 0
Australia
Funding source category [18] 315944 0
Commercial sector/Industry
Name [18] 315944 0
Sagewood
Country [18] 315944 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Associate Professor Hayley Christian, Telethon Kids Institute
Address
X
Country
Australia
Secondary sponsor category [1] 316596 0
University
Name [1] 316596 0
University of Western Australia
Address [1] 316596 0
X
Country [1] 316596 0
Australia
Secondary sponsor category [2] 318081 0
University
Name [2] 318081 0
University of South Australia
Address [2] 318081 0
Country [2] 318081 0
Australia
Secondary sponsor category [3] 318082 0
University
Name [3] 318082 0
University of Queensland
Address [3] 318082 0
Country [3] 318082 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313655 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 313655 0
http://www.research.uwa.edu.au/staff/human-research/welcome-to-HREO
Ethics committee country [1] 313655 0
Australia
Date submitted for ethics approval [1] 313655 0
31/08/2023
Approval date [1] 313655 0
27/11/2023
Ethics approval number [1] 313655 0
2023/ET000187

Summary
Brief summary
Physically active play is critical during the early years of life for facilitating children’s health and development. Just one in three Australian children aged 2 to 5 years achieve the recommended three hours of daily physical activity. Early childhood education and care (ECEC) services are a key setting to intervene to improve physical activity levels.

Our prior research addressed the need for an ECEC specific physical activity policy. We successfully developed, implemented, and evaluated an evidence-informed ‘Play Active’ program (a Play Active policy with accompanying implementation support strategies) in a pilot trial of 79 ECEC services. With our partners, we are now investigating how best to scale-up Play Active to ensure its effective and fit for purpose. This scale-up research will reach more than 700 ECEC services and 100,000 children across Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128898 0
A/Prof Hayley Christian
Address 128898 0
Telethon Kids Institute 15 Hospital Ave Nedlands WA 6009
Country 128898 0
Australia
Phone 128898 0
+61 407 087 030
Fax 128898 0
Email 128898 0
Hayley.Christian@uwa.edu.au
Contact person for public queries
Name 128899 0
Ms Jenny Beer
Address 128899 0
Telethon Kids Institute 15 Hospital Ave Nedlands WA 6009
Country 128899 0
Australia
Phone 128899 0
+61 8 6319 1218
Fax 128899 0
Email 128899 0
Jenny.beer@telethonkids.org.au
Contact person for scientific queries
Name 128900 0
Ms A/Prof Hayley Christian
Address 128900 0
Telethon Kids Institute 15 Hospital Ave Nedlands WA 6009
Country 128900 0
Australia
Phone 128900 0
+61 407 087 030
Fax 128900 0
Email 128900 0
Hayley.Christian@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified full dataset
When will data be available (start and end dates)?
Available from 12 months after anticipated project end date, with no end date
Available to whom?
Academics and research staff
Available for what types of analyses?
Any purpose approved by the Principal Investigator and relevant ethics committees.
How or where can data be obtained?
Please contact the Principal Investigator via email on hayley.christian@uwa.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



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.