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DEFINITIONS
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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
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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
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Secondary ID [1]
310426
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Medical Research Future Fund MRFF: APP2022912
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Secondary ID [2]
311619
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Healthway: 34818
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Secondary ID [3]
311620
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Australian Research Council Centre of Excellence for Children and Families over the Life Course: CE200100025
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Universal Trial Number (UTN)
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Trial acronym
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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.
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Health condition
Health condition(s) or problem(s) studied:
Physical inactivity
331192
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Condition category
Condition code
Public Health
327968
327968
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
326822
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Prevention
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Intervention code [2]
328078
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Lifestyle
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Intervention code [3]
328079
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Behaviour
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline (primary endpoint)
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Secondary outcome [1]
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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).
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Assessment method [1]
432212
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Timepoint [1]
432212
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Baseline
12 months after baseline
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Secondary outcome [2]
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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.
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Assessment method [2]
432213
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Timepoint [2]
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24 months after baseline
30 months after baseline
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Secondary outcome [3]
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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.
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Assessment method [3]
432215
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Timepoint [3]
432215
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12 months after baseline
24 months after baseline
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Secondary outcome [4]
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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).
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Assessment method [4]
432218
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Timepoint [4]
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18 months after baseline
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Secondary outcome [5]
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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)
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Assessment method [5]
433027
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Timepoint [5]
433027
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Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
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Secondary outcome [6]
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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)
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Assessment method [6]
433028
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Timepoint [6]
433028
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Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
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Secondary outcome [7]
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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)
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Assessment method [7]
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Timepoint [7]
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Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
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Secondary outcome [8]
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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)
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Assessment method [8]
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Timepoint [8]
433030
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Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
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Secondary outcome [9]
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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)
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Assessment method [9]
433031
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Timepoint [9]
433031
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Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
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Secondary outcome [10]
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Effectiveness outcome (i), item 6: The amount of screen time provided each day to children
Assessment method: educator-reported instrument (Play Active website survey)
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Assessment method [10]
433032
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Timepoint [10]
433032
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Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
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Secondary outcome [11]
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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)
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Assessment method [11]
433033
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Timepoint [11]
433033
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Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
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Secondary outcome [12]
433034
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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)
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Assessment method [12]
433034
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Timepoint [12]
433034
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Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
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Secondary outcome [13]
433035
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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)
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Assessment method [13]
433035
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Timepoint [13]
433035
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Baseline (defined as the Play Active website self-assessment step)
12 months after baseline
24 months after baseline
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Secondary outcome [14]
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Dissemination (recruitment) outcome 1: Number of services registered
Assessment method: Website analytics
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Assessment method [14]
433036
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Timepoint [14]
433036
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2 months after baseline
4 months after baseline
6 months after baseline
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Secondary outcome [15]
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Dissemination (recruitment) outcome 2: Number of services becoming Play Active members
Assessment method: Website analytics
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Assessment method [15]
433037
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Timepoint [15]
433037
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6 months after baseline
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Secondary outcome [16]
433038
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Dissemination (recruitment) outcome 3: Number of services renewing membership
Assessment method: Website analytics
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Assessment method [16]
433038
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Timepoint [16]
433038
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30 months after baseline
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Secondary outcome [17]
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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)
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Assessment method [17]
433039
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Timepoint [17]
433039
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2 months after baseline
4 months after baseline
6 months after baseline
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Secondary outcome [18]
433040
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Process evaluation outcome - reach: The number and geographic spread of ECEC services registering at least one staff member
Assessment method: Website analytics
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Assessment method [18]
433040
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Timepoint [18]
433040
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Each 6 months after baseline
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Secondary outcome [19]
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Process evaluation outcome - adoption: The number and geographic spread of ECEC services purchasing membership
Assessment method: Website analytics
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Assessment method [19]
433041
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Timepoint [19]
433041
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Each 6 months after baseline
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Secondary outcome [20]
433042
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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
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Assessment method [20]
433042
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Timepoint [20]
433042
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Each 6 months after baseline
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Secondary outcome [21]
433043
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Process evaluation outcome - engagement (ii): The number and geographic spread of ECEC services using SMS and email prompts
Assessment method: Website analytics
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Assessment method [21]
433043
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Timepoint [21]
433043
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Each 6 months after baseline
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Secondary outcome [22]
433044
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Process evaluation outcome - acceptability: ECEC staff self-reported acceptability
Assessment method: Play Active website survey
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Assessment method [22]
433044
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Timepoint [22]
433044
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6 months after baseline
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Secondary outcome [23]
433045
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Process evaluation outcome - appropriateness: ECEC staff self-reported appropriateness
Assessment method: Play Active website survey
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Assessment method [23]
433045
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Timepoint [23]
433045
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6 months after baseline
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Secondary outcome [24]
433046
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Process evaluation outcome - feasibility ECEC staff self-reported feasibility
Assessment method: Play Active website survey
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Assessment method [24]
433046
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Timepoint [24]
433046
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6 months after baseline
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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.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/05/2024
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Actual
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Date of last participant enrolment
Anticipated
31/10/2024
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Actual
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Date of last data collection
Anticipated
30/04/2027
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Actual
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Sample size
Target
741
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Medical Research Future Fund
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Address [1]
314634
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X
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Country [1]
314634
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Australia
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Funding source category [2]
315928
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Government body
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Name [2]
315928
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Healthway
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Address [2]
315928
0
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Country [2]
315928
0
Australia
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Funding source category [3]
315929
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Government body
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Name [3]
315929
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Australian Research Council Centre of Excellence for Children and Families over the Life Course (Life Course Centre)
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Address [3]
315929
0
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Country [3]
315929
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Australia
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Funding source category [4]
315930
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Charities/Societies/Foundations
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Name [4]
315930
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Cancer Council WA
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Address [4]
315930
0
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Country [4]
315930
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Australia
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Funding source category [5]
315931
0
Charities/Societies/Foundations
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Name [5]
315931
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YMCA WA
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Address [5]
315931
0
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Country [5]
315931
0
Australia
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Funding source category [6]
315932
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Charities/Societies/Foundations
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Name [6]
315932
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Australian Childcare Alliance WA
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Address [6]
315932
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Country [6]
315932
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Australia
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Funding source category [7]
315933
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Charities/Societies/Foundations
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Name [7]
315933
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Play Matters Collective
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Address [7]
315933
0
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Country [7]
315933
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Australia
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Funding source category [8]
315934
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Government body
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Name [8]
315934
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Department of Local Government, Sport and Cultural Industries, Western Australia
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Address [8]
315934
0
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Country [8]
315934
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Australia
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Funding source category [9]
315935
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Charities/Societies/Foundations
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Name [9]
315935
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Early Childhood Australia
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Address [9]
315935
0
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Country [9]
315935
0
Australia
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Funding source category [10]
315936
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Government body
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Name [10]
315936
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Health and Wellbeing Queensland
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Address [10]
315936
0
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Country [10]
315936
0
Australia
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Funding source category [11]
315937
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Charities/Societies/Foundations
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Name [11]
315937
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Australian Childcare Alliance SA
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Address [11]
315937
0
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Country [11]
315937
0
Australia
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Funding source category [12]
315938
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Charities/Societies/Foundations
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Name [12]
315938
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Goodstart Early Learning
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Address [12]
315938
0
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Country [12]
315938
0
Australia
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Funding source category [13]
315939
0
Charities/Societies/Foundations
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Name [13]
315939
0
Early Childhood Australia WA
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Address [13]
315939
0
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Country [13]
315939
0
Australia
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Funding source category [14]
315940
0
Charities/Societies/Foundations
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Name [14]
315940
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Play Australia
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Address [14]
315940
0
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Country [14]
315940
0
Australia
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Funding source category [15]
315941
0
Charities/Societies/Foundations
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Name [15]
315941
0
Nature Play Australia
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Address [15]
315941
0
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Country [15]
315941
0
Australia
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Funding source category [16]
315942
0
Charities/Societies/Foundations
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Name [16]
315942
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Australian Childcare Alliance QLD
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Address [16]
315942
0
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Country [16]
315942
0
Australia
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Funding source category [17]
315943
0
Commercial sector/Industry
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Name [17]
315943
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Sonas Childcare
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Address [17]
315943
0
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Country [17]
315943
0
Australia
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Funding source category [18]
315944
0
Commercial sector/Industry
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Name [18]
315944
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Sagewood
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Address [18]
315944
0
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Country [18]
315944
0
Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Associate Professor Hayley Christian, Telethon Kids Institute
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Address
X
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Country
Australia
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Secondary sponsor category [1]
316596
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University
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Name [1]
316596
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University of Western Australia
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Address [1]
316596
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X
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Country [1]
316596
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Australia
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Secondary sponsor category [2]
318081
0
University
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Name [2]
318081
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University of South Australia
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Address [2]
318081
0
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Country [2]
318081
0
Australia
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Secondary sponsor category [3]
318082
0
University
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Name [3]
318082
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University of Queensland
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Address [3]
318082
0
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Country [3]
318082
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313655
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The University of Western Australia Human Research Ethics Committee
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Ethics committee address [1]
313655
0
http://www.research.uwa.edu.au/staff/human-research/welcome-to-HREO
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Ethics committee country [1]
313655
0
Australia
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Date submitted for ethics approval [1]
313655
0
31/08/2023
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Approval date [1]
313655
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27/11/2023
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Ethics approval number [1]
313655
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2023/ET000187
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Hayley Christian
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Address
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Telethon Kids Institute 15 Hospital Ave Nedlands WA 6009
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Country
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Australia
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Phone
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+61 407 087 030
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Fax
128898
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Email
128898
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[email protected]
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Contact person for public queries
Name
128899
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Ms Jenny Beer
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Address
128899
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Telethon Kids Institute 15 Hospital Ave Nedlands WA 6009
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Country
128899
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Australia
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Phone
128899
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+61 8 6319 1218
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Fax
128899
0
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Email
128899
0
[email protected]
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Contact person for scientific queries
Name
128900
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Ms A/Prof Hayley Christian
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Address
128900
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Telethon Kids Institute 15 Hospital Ave Nedlands WA 6009
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Country
128900
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Australia
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Phone
128900
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+61 407 087 030
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Fax
128900
0
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Email
128900
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified full dataset
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When will data be available (start and end dates)?
Available from 12 months after anticipated project end date, with no end date
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Available to whom?
Academics and research staff
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Available for what types of analyses?
Any purpose approved by the Principal Investigator and relevant ethics committees.
Query!
How or where can data be obtained?
Please contact the Principal Investigator via email on
[email protected]
Query!
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.
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