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Trial registered on ANZCTR


Registration number
ACTRN12621000987864
Ethics application status
Approved
Date submitted
26/04/2021
Date registered
27/07/2021
Date last updated
27/10/2023
Date data sharing statement initially provided
27/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the impact of a multi-component implementation intervention on early childhood education and care (ECEC) services implementation of indoor-outdoor free play recommendations and the effect on opportunities for child outdoor free play.
Scientific title
A randomised trial of a multi-component implementation intervention on childcare service implementation of opportunities for outdoor free play consistent with sector recommendations.
Secondary ID [1] 303415 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 320723 0
Obesity 320725 0
Condition category
Condition code
Public Health 318567 318567 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention length has been reduced to approximately 6 months and some adaptations made to intervention components to align with new guidelines around outdoor free play.

The intervention will target early childhood education and care (ECEC) service Nominated Supervisors (NS), Service Champions (SC) and Educators to support their implementation of indoor-outdoor free play opportunities. Specifically, childcare services will be supported to provide or increase the time available for unrestricted access to outdoor play areas of the service, to allow children the opportunity to engage in outdoor free play.
The implementation intervention will seek to provide support to services to increase awareness of continuous free play recommendations, facilitate the process of amending service schedules and environments, and support childcare service educators with implementing changes as required. The intervention is designed to be flexible in delivery to accommodate the needs of the services, and a facilitation style approach will be applied. The research team will train health promotion officers (with qualifications in nutrition, health promotion and physical education) to deliver the following strategies via six key intervention components:
a) Identify and prepare champions:
Prior to the first intervention contact, ECEC services will be asked via email to nominate a service champion for the initiative. This may be the Service Manager or another existing staff member e.g. Room Leader, who will be responsible for supporting implementation of indoor-outdoor free play at the service. A position description for the champion will be provided outlining the expectations for the role. This includes overseeing the development and implementation of an action plan (see c) and monitoring implementation progress. As part of the audit and feedback process (see #) the nominated champion will be supported by the HPO to reflect on changes to practice, identify positive implementation outcomes for educators and children and share these observations with staff and parents. Throughout the intervention, the champion will also be asked to provide encouragement and recognition and/or further support to overcome indifference or behavioural challenges that may arise in regards to the intervention.
b) Educational Outreach visit(s):
Initially (week 1) a 30 minute face-to-face or online meeting will be undertaken with the Service Manager and appointed GOGA champion (and/or relevant room leader). The purpose of this meeting will be to orient the service to the implementation intervention (planned schedule of contacts with the service), provide and reinforce information on sector guidelines and provide supporting information on other benefits of increasing outdoor free play, and discussions around how indoor-outdoor free play may complement existing service philosophy and priorities. An action planning workbook (see c) will be provided and the steps to complete the workbook explained. In order to ensure the action plan has “all of service” input, the nominated supervisor and champion will be asked to plan an information session regarding the initiative for educators at the service (prioritising those in the 3-6 year old room) and identify a strategy to receive wider input from relevant staff into the action plan. The service will be asked to complete these activities prior to week 8 of the intervention. To inform staff of the initiative, the HPO will offer to present an information session (approx. 25 mins), for example, at a staff meeting, Alternatively the service may elect to receive a pre-recorded version of information session presentation for staff to watch, at a time of convenient. The Nominated supervisor/ champion will guide what process to take to obtain wider input on the action plan from educators. This could include a brainstorming session approx. 20 mins), facilitated by the HPO at the conclusion of the delivered presentation or the service may conduct this process independently as per their usual service procedures for consulting with staff.
c) Develop a formal implementation blueprint:
The HPO will provide an Action Plan workbook at the first educational outreach meeting and discuss how it is to be used to guide service development of a plan to implement indoor outdoor free play. The workbook includes: space to identify and document motivations and anticipated benefits of increasing outdoor free play opportunities, guidance around identifying suitable long and short term goals, an environmental checklist, problem solving tips and sample actions. The service champion will be asked to complete the work book and final action plan prior to week 8 of the intervention.
d) Provide local technical assistance:
The HPO will provide technical assistance at approximately weeks 6-8, week 8-10 and week 18-20.
3-7 weeks after the first educational outreach visit, the HPO will meet with the Nominated supervisor and/ or champion to view and discuss the service action plan. This visit will take approximately 20-30 minutes, and is an opportunity to ensure the action plan contains desired elements and appropriate timeframes for actions. The HPO will also provide positive reinforcement, facilitate reflection and provide problem solving advice and additional resources if required. The HPO will request an electronic copy of the final action plan to use as a reference during subsequent contacts.
At approximately week 8-10 and approximately week 18-20, the HPO will undertake a 10- 20 minute phone support call with the GOGA champion which will include reviewing progress with goals and actions, problem solving and setting any new goals or actions if required. This support will be tailored according to the preferences, needs and/or barriers of each service, and as such additional support calls may occur at time points outside of those specified and will be recorded as part of adaptations to the program.
e) Distribute educational materials:
At the first educational outreach visit, in addition to action plan workbook, the HPO will provide the Service Manager and GOGA champion with an electronic and hard copy information pack including information regarding how the intervention aligns with ECEC accreditation standards and COVID 19 social distancing guidance by the NSW Department of Education for ECEC services. Additionally, case studies and family newsletter snippets communicating changes at the service and the benefits of increasing opportunities for outdoor free play for families will be provided. A GOGA newsletter for all ECEC staff will be provided for distribution on four occasions throughout the intervention period and will include tips on overcoming common barriers to implementation (e.g. adverse weather, outdoor play resources and equipment).
f) Performance feedback and review:
ECEC services will receive written and verbal feedback on their performance against at approximately week 12 (mid-way through the intervention) via a phone (duration approximately 30 minutes). The HPO will provide the GOGA champion with a hard copy or electronic version of an observation tool to observe, record and reflect on both indoor and outdoor free play opportunities provided over a 5-day period. On completion, the GOGA champion will submit the tool to their HPO. Based on this data, a written feedback report comparing the current provision of opportunities for outdoor free play with service goals and with the provision of outdoor free play at baseline will be provided. Verbal performance feedback and recognition of achievements will also be provided by phone.

Over the 6 month intervention period, fidelity to the intervention delivery will be recorded by the HPO in a REDCap monitoring instrument specifically designed to capture timing, duration, and delivery of specific content outlined for each of the above components. Adaptations and/or additional strategies undertaken as a result of applying the flexible facilitation approach will also be classified and recorded in the monitoring instrument.

Intervention delivery modality will also adhere to general health requirements during the pandemic regarding appropriate contact with services and other agencies.
Intervention code [1] 319728 0
Behaviour
Comparator / control treatment
The control group will receive usual care from the health promotion team in the region. This may include email contact and newsletters and offer of online training from the state health promotion team. This does not typically target the implementation of indoor-outdoor play opportunities or focus explicitly on outdoor play opportunities. The research team will monitor such contact.
Control group
Active

Outcomes
Primary outcome [1] 326519 0
Mean minutes of time children have the opportunity to spend in the outdoor environment during unstructured free play time (as a continuous outcome).
Educators within the service will report on the duration (in minutes and/or hours) of outdoor and indoor-outdoor free play each day during their hours of operation. The research team will develop a detailed log that will be completed by educators or other relevant childcare staff. Any additional information not reported or essential to assess duration of outdoor and indoor-outdoor free play opportunities will be obtained via a follow up phone call by a trained member of the research team. Service routines and other supplementary documents (e.g. existing service records, policies) will also be reviewed to provide additional information, where necessary. This will be assessed daily for a one-week period (5 consecutive days), to calculate the average time per day. At the end of the 6-month intervention, we will also undertake a one-day observation as part of data quality checks.
Timepoint [1] 326519 0
Baseline, approximately 6 months (primary end-point) and 18 months post-intervention commencement.
Secondary outcome [1] 391756 0
Proportion of time (minutes) children have the opportunity to spend in the outdoor environment during unstructured free play time (as a continuous outcome) This is operationalised as the percentage of total free play minutes where services are providing children with access to the outdoor environment during free play period. Educators within the service will report on the duration (in minutes and/or hours) of indoor, outdoor, and indoor-outdoor free play during their hours of operation, everyday for a one week period (5 consecutive days). The research team will develop a detailed log that will be completed by educators or other relevant childcare staff. Any additional information not reported or essential to assess duration of free play opportunities will be obtained via a follow up phone call by a trained member of the research team. Service routines and other supplementary documents will also be reviewed to provide additional information, where necessary.
Timepoint [1] 391756 0
This change was made prior to recruitment. Baseline, approximately 6 months (primary end-point) and 18 months post-intervention commencement.
Secondary outcome [2] 391901 0
A cost consequence analysis will be conducted from the perspectives of the childcare and the health service service. The costs and resource use for the intervention and usual care will be derived from project records (staff and consumables), service supervisor and educator survey. Additional costs in the intervention group are anticipated to be labour (implementation support); time and resource costs. Where data are unavailable, the basis for assumptions will be detailed. It is anticipated that a synthesis of other studies will not be required to derive appropriate assumptions. The reportable outcomes will be mean cost per centre, mean incremental cost, and total cost to health providers used to calculate a composite score- the Incremental Cost Effectiveness Ratio (ICER)
Timepoint [2] 391901 0
6 months post-intervention commencement.
Secondary outcome [3] 397317 0
Level of educator interaction with children during free play.

This will be assessed using the movement environment rating scale (MOVERS). Members of the research team will observe interactions between educators and children for one session (morning or afternoon) lasting 3-4 hours. The MOVERS instrument includes 11 items across 4 subscales including; Curriculum, environment and resources for physical development; Pedagogy for physical development; and Supporting physical activity and critical thinking.
Timepoint [3] 397317 0
6 months post-intervention commencement.
Secondary outcome [4] 428270 0
Implementation of the indoor-outdoor (free flow-routine) recommendation during the entire service operation period (dichotomous outcome).

The proportion of service that have implemented indoor-outdoor recommendations for the entire service operation period will be compared between groups. Educators within the service will report on the duration (in minutes and/or hours) of outdoor and indoor-outdoor free play each day during their hours of operation. The research team will develop a detailed log that will be completed by educators or other relevant childcare staff. Any additional information not reported or essential to assess duration of outdoor and indoor-outdoor free play opportunities will be obtained via a follow up phone call by a trained member of the research team. Service routines and other supplementary documents (e.g. existing service records, policies) will also be reviewed to provide additional information, where necessary. This will be assessed daily for a one-week period (5 consecutive days). One day will be randomly selected to assess whether indoor-outdoor (free-flow routines) were fully implemented (defined as implemented during the entire service opening period).
Timepoint [4] 428270 0
Baseline, approximately 6 months (primary end-point) and 18 months post-intervention commencement.

Eligibility
Key inclusion criteria
Childcare services will be the primary participants in the trial. Services will be eligible to participate if they:
1. are based in Hunter New England region of New South Wales
2. are long day care or preschool-services
3. have an indoor-only free play opportunity during the day
4. have an educator/room supervisor that can understand English sufficiently to engage with the intervention
5. care for children aged 3-6 years
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Services will be excluded if they :
1. cater solely to special needs populations
2. are a Department of Education run service

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Services will be randomly allocated using a block randomisation procedure in a 1:1 ratio to either the intervention or control group. Randomization will be carried out centrally, where the individuals recruiting services will contact a central coordinator after consent has been sought.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An statistician independent to the study will generate sequence allocation using a computerised random number function. Allocation will be stratified by socioeconomic status (as determined by service postcode) given potential association with implementation of physical activity policies.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
With a conservative estimate of a 70% eligibility and 50% consent rate, and assuming a 20% loss-to-follow-up, a sample of 100 childcare services at baseline will provide a sample of 80 childcare services at 12 month follow-up. A total of 200 participants from 100 childcare service will be recruited (100 nominated supervisors and 100 educators) however the primary outcome assessment will occur at the level of the centres.
This remains unchanged.

Analyses will be performed under an intention to treat framework, with the childcare service as the unit of analysis. Intervention effects will be assessed using a linear regression model for the continuous primary outcome and a logistic regression model for the dichotomous secondary outcome, both of which will include a variable for treatment group. A separate analysis will be undertaken at 6 and 18-months. Multiple imputations will be performed as part of a sensitivity analysis for services lost to follow-up. A sensitivity analysis will also be undertaken, adjusting for service characteristics that appear imbalanced between groups at baseline. Additionally we will plan to undertake a subgroup analysis examining potential intervention effect among services with the lowest baseline outdoor free play opportunities (specified as the lowest third quartile).

For the primary outcome, the recruitment of approximately 100 services will allow the detection of an absolute difference of 27.28 minutes in the time children have the opportunity spend in the outdoor environment during unstructured free play, assuming a standard deviation of 43 minutes, with 80% power and an alpha of 0.05. An additional 27 minutes of outdoor free play time (estimating this will increase total outdoor free play opportunity time to >1 hour for most services) is associated with an increase of 10 minutes in child moderate-vigorous physical activity (MVPA) per day. An increase of 10 minutes in MVPA in children aged 3 to 6 years has been found to have clinically significant beneficial effects on fat mass and peak bone mass.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/08/2021
Actual
20/09/2021
Date of last participant enrolment
Anticipated
31/12/2021
Actual
29/03/2022
Date of last data collection
Anticipated
29/04/2024
Actual
Sample size
Target
200
Accrual to date
Final
208
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307832 0
Government body
Name [1] 307832 0
National Health and Medical Research Council
Country [1] 307832 0
Australia
Funding source category [2] 307941 0
Government body
Name [2] 307941 0
Hunter New England Population Health
Country [2] 307941 0
Australia
Funding source category [3] 308106 0
Government body
Name [3] 308106 0
NSW Centre for Population Health
Country [3] 308106 0
Australia
Primary sponsor type
Individual
Name
A/Prof Serene (Sze Lin) Yoong
Address
Deakin University, 221 Burwood Highway, Burwood VIC 3125, Australia
Country
Australia
Secondary sponsor category [1] 308538 0
Individual
Name [1] 308538 0
Dr Alice Grady
Address [1] 308538 0
University of Newcastle, c/o Booth Building, Longworth Avenue, Wallsend NSW 2287
Country [1] 308538 0
Australia
Secondary sponsor category [2] 308660 0
Individual
Name [2] 308660 0
Prof Luke Wolfenden
Address [2] 308660 0
University of Newcastle, c/o Booth Building, Longworth Avenue, Wallsend NSW 2287
Country [2] 308660 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307834 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 307834 0
Ethics committee country [1] 307834 0
Australia
Date submitted for ethics approval [1] 307834 0
15/10/2020
Approval date [1] 307834 0
15/12/2020
Ethics approval number [1] 307834 0
2019/ETH12353
Ethics committee name [2] 307850 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 307850 0
Ethics committee country [2] 307850 0
Australia
Date submitted for ethics approval [2] 307850 0
22/01/2021
Approval date [2] 307850 0
28/01/2021
Ethics approval number [2] 307850 0
H-2008-0343
Ethics committee name [3] 307851 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [3] 307851 0
Ethics committee country [3] 307851 0
Australia
Date submitted for ethics approval [3] 307851 0
15/02/2021
Approval date [3] 307851 0
19/02/2021
Ethics approval number [3] 307851 0
20215523-5944
Ethics committee name [4] 314032 0
Deakin University HREC
Ethics committee address [4] 314032 0
Ethics committee country [4] 314032 0
Australia
Date submitted for ethics approval [4] 314032 0
Approval date [4] 314032 0
21/03/2023
Ethics approval number [4] 314032 0
Ethics committee name [5] 314044 0
Deakin University HREC
Ethics committee address [5] 314044 0
Ethics committee country [5] 314044 0
Australia
Date submitted for ethics approval [5] 314044 0
Approval date [5] 314044 0
21/03/2023
Ethics approval number [5] 314044 0

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

Contacts
Principal investigator
Name 108670 0
A/Prof Serene (Sze Lin) Yoong
Address 108670 0
CIA has moved to Deakin Universiy, 221 Burwood Highway, Burwood VIC 3125, Australia
Country 108670 0
Australia
Phone 108670 0
+6134924 6122
Fax 108670 0
Email 108670 0
s.yoong@deakin.edu.au
Contact person for public queries
Name 108671 0
Serene (Sze Lin) Yoong
Address 108671 0
CIA has moved to Deakin Universiy, 221 Burwood Highway, Burwood VIC 3125, Australia
Country 108671 0
Australia
Phone 108671 0
+613 9214 4935
Fax 108671 0
Email 108671 0
s.yoong@deakin.edu.au
Contact person for scientific queries
Name 108672 0
Serene (Sze Lin) Yoong
Address 108672 0
CIA has moved to Deakin Universiy, 221 Burwood Highway, Burwood VIC 3125, Australia
Country 108672 0
Australia
Phone 108672 0
+613 9214 4935
Fax 108672 0
Email 108672 0
s.yoong@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled trial of an implementation strategy delivered at scale to increase outdoor free play opportunities in early childhood education and care (ECEC) services: a study protocol for the get outside get active (GOGA) trial.2022https://dx.doi.org/10.1186/s12889-022-12883-w
N.B. These documents automatically identified may not have been verified by the study sponsor.