Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001089729
Ethics application status
Approved
Date submitted
8/06/2022
Date registered
5/08/2022
Date last updated
2/02/2025
Date data sharing statement initially provided
5/08/2022
Date results provided
2/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Randomised Controlled Trial Examining the Potential Impact of the Sustaining Play, Sustaining Health (SPSH) Program in Early Childhood Education and Care Services
Scientific title
A pilot randomised controlled trial to assess the impact of a sustainability strategy on the sustainment of outdoor free play programs in early childhood education and care services.
Secondary ID [1] 306975 0
None
Universal Trial Number (UTN)
Trial acronym
SPSH (Sustaining Play, Sustaining Health) trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Inactivity 326091 0
Obesity 326615 0
Condition category
Condition code
Public Health 323402 323402 0 0
Health promotion/education
Public Health 323403 323403 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 6-month pilot intervention will be delivered specifically in Early Childhood Education and Care (ECEC) services and will target ECEC service Nominated Supervisors (NS) and Educators to support their implementation of a sustainability strategy to continue to provide indoor-outdoor free play routines. The potential unstructured free play activities that may occur throughout this intervention will be either outdoor free play only or indoor-outdoor free play (where periods of free play are located in both the indoor and outdoor environments, where children can move freely between the two). Specifically, ECEC services will be supported to implement a sustainability strategy that will help to integrate indoor-outdoor free play routines into their daily routine and service policy. The intervention was designed to target 20 barriers associated with the sustainment of physical activity programs in the ECEC setting, mapped to the domains of the Integrated Sustainability Framework developed by Shelton and colleagues (2018). This resulted in the development of eight strategies that sought to address these barriers and support the sustainment of improving implementation outcomes in the setting. The sustainability strategy, includes i) identifying an opinion leader to act as a key driver of the sustainability strategy, ii) re-affirming the services' intent for continuity, iii) providing the service with technical support and educational resources to self-direct the strategy, iv) developing a formal sustainment blueprint, v) engaging family and community members, vi) reviewing and changing service policy to integrate indoor-outdoor free play routines and vii) developing an ongoing monitoring plan to self-direct the sustainment of the Evidence-Based Intervention (EBI) well after the intervention period. The delivery of the strategy will include a minimum of 4 remotely delivered scheduled contacts including, 2 meetings via videoconference, and 2 support emails. Contacts will target the NS and an educator responsible for supporting the implementation of physical activity programs in the ECEC service. The intervention will be delivered by experienced health promotion officers employed by a local health promotion unit with tertiary qualifications in health. The development of the 6-month sustainability strategy was overseen by an advisory group consisting of implementation and behavioural scientists, health promotion staff and health policymakers.

a) Identify opinion leaders at the service: To target the barriers; lack of administrative buy-in and support/leadership/management and lack of program leaders/facilitators/champions, ECEC services will be asked to identify any key drivers of implementation or “educationally influential” colleagues, who could be the service manager or another existing staff member e.g., Room Leader. This person(s) will be invited to participate in service contacts along with the centre manager/NS. The health promotion officer will determine the existing roles and influence of these staff members in current implementation processes as a component of the first 30–60-minute introductory meeting video call contact. The sustainability strategy will be discussed and additional roles or tasks for these key staff members will be co-developed as part of the process of undertaking a sustainability action plan (see strategy d for more detail).

b) Re-affirm intent of continuity: To address the barriers; lack of motivation/interest, limited cost-effectiveness/feasibility of program, time required to implement and record uptake of the program, and competing resources, responsibilities and curriculum demands, services will be supported to reaffirm the services’ intent of continuity and readiness for long term implementation of the EBI. To do this, the health promotion officer will explicitly ask the NS and the opinion leader regarding their intention to continue the implementation of their current indoor-outdoor free play program during the introductory videoconference call. To explore the likelihood of sustaining long-term change, the health promotion officer will also ascertain the services’ motivations behind their original implementation, determine any barriers and facilitators to ongoing EBI implementation, and readiness to implement a sustainability strategy to enhance integration into usual care. As part of supporting a commitment to long-term change, the health promotion officer will facilitate the services to draft ideas for a formal “motivational statement” for the implementation of the EBI. Services will be supported to use this as part of the staff and community communications, as well as for inclusion in policy and procedure updates as appropriate.

c) Provide local technical assistance to support integrating strategies: To address the barriers; lack of training/professional development opportunities to upskill, and lack of clear data on effectiveness of program, we will provide local technical assistance in the form of 2, 30–60-minute videoconference calls from the health promotion officer at months 1 and 3, and a minimum of 2 policy review emails at months 2 and 4. throughout the intervention period to assist them with implementing the sustainability strategy. Each contact will draw on continuous quality improvement principles to review progress on the sustainability action plan and provide feedback on the integration of sustainability strategies. The first call will occur after recruitment and will focus on introducing the trial, explaining the roles of the opinion leader and the NS (see a), understanding any determinants of sustainability for the service (see b), and discussing the development of the sustainability action plan (see d). The second video call will be at the 3-month time point which will focus on the services’ progress with their sustainability action plan and any experienced challenges. The first email will be before the initial support call at recruitment to provide the service with a resource pack. The 2 emails will consist of providing feedback on the services’ policy, through the use of a template and suggestions of amendments (see g). Additional support contacts may occur at time points outside of those specified if further support is required and will be recorded as part of adaptations to the program.

d) Develop a formal sustainment blueprint: Services will be supported to develop an action plan t implement the sustainability strategy. This action plan will allow for the identification of strategies to be put in place as well as sustainability strategies that may have already been undertaken (fully or partially). Examples of strategies include notifying families, community members and staff of indoor-outdoor free play, updating the service policy, and conducting indoor-outdoor free play as part of daily routine. Progress with the plan will be monitored at the second 3-month contact and support provided to meet the plan as required.

e) Distribute educational materials: A digital resource pack developed or adapted from materials previously used by the research team to target determinants of sustainability will be emailed to the services. The health promotion officer will then discuss the content of the resource pack as part of the introductory video call. The resources provided are designed to assist with potential determinants to both maintaining long-term EBI implementation and support implementation of the sustainability action plan. Resources include fact sheets of external organisations which support outdoor free play, how outdoor free play aligns with the sector accreditation standards, a summary of the general health recommendations during the pandemic relating to outdoor play, Australian Physical Activity guidelines, family and service templates to include as part of orientation packages, a service policy template and tips for maintaining indoor-outdoor free play routines across all seasons. Additionally, to support ongoing support from families, newsletter communication snippets to be used in service family newsletters will be provided. Further resources will be developed and provided tailored to the service’s specific needs.

f) Engaging with family members: This strategy will include the provision of resources including 6 newsletter communication snippets including information around benefits of outdoor free play, outdoor play in various seasons and outdoor play and general health recommendations. These are to be used in service family newsletters or service social media groups at the perusal of the service, with a minimum to send out 1 newsletter snippet throughout the 6-month intervention. Another strategy to engage with family members and the community is through the use of a template for the inclusion of indoor-outdoor free play in the family orientation package. Services will be asked to distribute these using their usual communication channels.

g) Reviewing and embedding change into policy: This strategy aims to ensure that the commitment to sustain indoor-outdoor free play routines is reflected in relevant service policy. At the 2-month and 4-month timepoint contact, the health promotion officer will review the services policies and suggest potential changes to promote the continuation of indoor-outdoor free play practices.

h) Develop an ongoing monitoring strategy: At the initial contact, an “ongoing monitoring plan” item will be added to the sustainability action plan to develop a way of ensuring ongoing monitoring. Services will be encouraged to develop their own plan during the intervention contacts with the health promotion officers to ensure the EBI continues to be implemented long-term. Alternatively, services are provided with the option to continue to use the Free Play Record (FPR) developed by the research team as a way of continuing to document implementation twice a year.
Intervention code [1] 323480 0
Lifestyle
Comparator / control treatment
The delivery of intervention components will be under the control of the research team and will not be provided to the control group services during the intervention period. The 10 ECEC services in the control group will receive ‘usual care’. This includes the provision of a generic email with a link to the NSW government's general health recommendations during the global pandemic.
Control group
Active

Outcomes
Primary outcome [1] 331222 0
Acceptability, feasibility, and impact of the SPSH program for the sustainment of indoor–outdoor free-play programs (for this trial, defined as the ongoing implementation of evidence-based practice) in ECEC services. Acceptability: The nominated supervisor/service manager at the intervention service was asked to report via an online survey on seven items using a 5-point Likert scale, capturing information related to the acceptability (e.g., attitude, burden, ethicality of the program, coherence, effectiveness, self-efficacy, opportunity costs) of the SPSH program (the sustainment strategies). This survey also consisted of an open-ended item to capture general comments made by the service managers on the acceptability of the SPSH program. Generally, one on the scale indicates disagreement with the statement, while response option five indicates agreement with the statement, except for Burden (domain two) and Opportunity costs (domain six), which were in the reverse order. These items were underpinned by the Theoretical Framework of Acceptability (TFA), a validated framework used to assess the acceptability of healthcare interventions from the perspectives of the recipients. High acceptability was defined as scores above the neutral rating (i.e., scores >3), and low acceptability was defined as scores =3, consistent with other studies using this framework. Feasibility Nominated Supervisors were asked to report via an online survey, using a 5-point Likert scale (strongly disagree to strongly agree) the extent to which they agree that the SPSH program sustainment support was feasible (i.e. continuing to implement the SPSH program seems possible, easy, and doable) and it’s fit within the service. This survey also consisted of an open-ended item to capture any further comments on the general feasibility of the SPSH program. This survey was adapted from the Feasibility of Intervention measure (61). A total mean of =4 (higher scores) indicated greater feasibility, while =2 (lower scores) indicated lower feasibility, consistent with the recommendations of Weiner et al. (2017). Impact: The delivery of indoor–outdoor free-play program was assessed at baseline, six-months, and 12-months post baseline via the Free Play Record (FPR). The FPR asked nominated supervisors or opinion leaders to report on the number of minutes children spent in the indoor-only, outdoor-only, and indoor-outdoor play environments as part of free play sessions. We considered the SPSH program to be useful as supporting some level of sustainment if the mean minutes of indoor-outdoor free play in the intervention group were higher than that in the control group. Adoption: Adoption of the SPSH program was assessed by determining how many strategies within the “Sustainability Action Plan” were marked as “complete” by the end of the intervention period (approximately the six-month time point). This indicates the number of strategies applied and therefore adopted by the service throughout the duration of the intervention, according to the intentions of the SPSH program. For a service to be considered “adopting SPSH recommendations”, the service needed to have completed at least one action from each of the four broad sustainment strategies.
Timepoint [1] 331222 0
6-months post-intervention commencement
Secondary outcome [1] 409232 0
Feasibility of use of trial methods to inform the conduct of a fully powered RCT. Feasibility of trial methods: To assess whether the trial methods were feasible and replicable, project records were used to report consent rate, percentage of missing data from completion of the FPR, comparison of consenter/non-consenter characteristics, attrition rate, withdrawal and reasons and contamination. Fidelity: Fidelity was assessed using project records, where the research team documented the extent to which each sustainment strategy was delivered by the HPOs and accepted by the service, both during recruitment and intervention delivery on an internal spreadsheet. For each intervention contact, the HPOs recorded time spent, staff involved and whether it was completed.
Timepoint [1] 409232 0
6-month post-intervention commencement
Secondary outcome [2] 409233 0
Barriers and facilitators to the sustainment of indoor–outdoor free-play programs in ECEC services. At baseline and the six-months follow-up, nominated Supervisors were asked to report via a 9-item online/telephone survey, using a 5-point Likert scale (completely disagree to completely agree) the extent to which they agree with statements relating to potential barriers and facilitators to sustaining the evidence-based intervention (indoor-outdoor free play). This survey included an adapted version of the validated measure of sustainability determinants framed across the constructs of the Integrated Sustainability Framework – the IMPRESS-C.
Timepoint [2] 409233 0
Baseline, 6-months post-intervention commencement
Secondary outcome [3] 409680 0
The direct cost of each sustainment strategy delivered by the HPOs, including labour (i.e., HPO preparation, administration and delivery of the program) was calculated, as per previous analysis. In addition, the cost for nominated supervisor/opinion leaders to receive the SPSH program delivered by the HPOs, and time taken to implement the strategies were also calculated.
Timepoint [3] 409680 0
12-months post-intervention commencement

Eligibility
Key inclusion criteria
Early Childhood Education and Care services will be the primary participants in the trial. Services will be eligible to participate if they:
1. are in the NSW, Australia region
2. are a long day care or preschool service
3. report implementing indoor-outdoor free play routines for most of the day (i.e., defined as equal to or less than 30 minutes of indoor-only free play per day) of a randomly selected week since July 2021.
4. 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. Implemented indoor–outdoor free play programs prior to the introduction of the COVID-19 guidance (July 2021) at the time of completion of a telephone interview/survey by the research team
2. had a nominated supervisor or staff who did not understand English as they could not participate adequately in the evaluation
3. Cater exclusively for special needs children
4. 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)
Following baseline data collection, an independent research team member used a computerised random number generator to block randomise services in a 1:1 ratio to either the intervention group or control group. Nominated Supervisors/service managers were notified of their group allocation via email following completion and quality checking of consent, eligibility, and baseline data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation (between two to four) was used to ensure group allocation was approximately equal.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
This pilot RCT will be conducted as an open trial as the sustainability strategy cannot be delivered without revealing the allocation of services. Therefore, services will not be blinded to group allocation, however, outcome assessors and those conducting data cleaning and data analysis will remain blinded to service allocation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses were performed using SPSS statistical software and Microsoft Excel. The main data collection point is six-months post baseline, with potential impact outcomes also assessed at 12-months post baseline. For all outcomes, we assessed for normality and used non-parametric tests where non-normality is observed.

Acceptability and Feasibility: At six-months post baseline, descriptive statistics (mean and standard deviation (SD) or median and range when non-normal) were generated for both acceptability and feasibility outcomes.

Impact: Total minutes of indoor-only, outdoor-only, and indoor-outdoor free play, were analysed separately at baseline, six-months, and 12-months post baseline for each group (intervention and control). The impact of the intervention was calculated by averaging the number of minutes for each play environment for each service. These averages were then used to obtain descriptive statistics and conduct normality and non-parametric analysis.
Normality was assessed using the Shapiro-Wilk test and due to non-normality non-parametric tests were then used to compare intervention and control group differences. This included the Mann-Whitney U test for between-group differences, in which a p-value was reported (p-value = 0.05 =statistically significant).

Adoption: The number of completed strategies was summed to determine how many strategies were completed by each service, and then a mean was calculated, to show the average number of strategies completed by all intervention services.

Feasibility of trial methods: Feasibility of the trial methods was analysed using descriptive statistics at both baseline, six-months and 12-months post baseline.

Barriers/facilitators:: The outer contextual factors and processes domains from the IMPRESS-C were scored individually at both baseline and six-months post baseline.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2022
Actual
26/09/2022
Date of last participant enrolment
Anticipated
19/09/2022
Actual
12/01/2023
Date of last data collection
Anticipated
29/09/2023
Actual
27/03/2024
Sample size
Target
20
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311288 0
Government body
Name [1] 311288 0
National Health and Medical Research Council
Country [1] 311288 0
Australia
Funding source category [2] 311440 0
Hospital
Name [2] 311440 0
Hunter New England Population Health
Country [2] 311440 0
Australia
Funding source category [3] 311441 0
Government body
Name [3] 311441 0
NSW Centre for Population Health
Country [3] 311441 0
Australia
Funding source category [4] 311442 0
University
Name [4] 311442 0
Swinburne University of Technology
Country [4] 311442 0
Australia
Funding source category [5] 318327 0
University
Name [5] 318327 0
Deakin University
Country [5] 318327 0
Australia
Primary sponsor type
Individual
Name
A/Professor Serene (Sze Lin) Yoong
Address
Swinburne University of Technology
John St, Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 312650 0
Individual
Name [1] 312650 0
Ms Noor (Nina) Imad
Address [1] 312650 0
Swinburne University of Technology John St, Hawthorn VIC 3122
Country [1] 312650 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310793 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 310793 0
Ethics committee country [1] 310793 0
Australia
Date submitted for ethics approval [1] 310793 0
29/04/2022
Approval date [1] 310793 0
16/05/2022
Ethics approval number [1] 310793 0
2019/ETH12353
Ethics committee name [2] 311049 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 311049 0
Ethics committee country [2] 311049 0
Australia
Date submitted for ethics approval [2] 311049 0
29/04/2022
Approval date [2] 311049 0
23/05/2022
Ethics approval number [2] 311049 0
H-2008-0343
Ethics committee name [3] 311336 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [3] 311336 0
Ethics committee country [3] 311336 0
Australia
Date submitted for ethics approval [3] 311336 0
14/06/2022
Approval date [3] 311336 0
06/07/2022
Ethics approval number [3] 311336 0
20225523-10247
Ethics committee name [4] 316962 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [4] 316962 0
Ethics committee country [4] 316962 0
Australia
Date submitted for ethics approval [4] 316962 0
21/03/2023
Approval date [4] 316962 0
17/04/2023
Ethics approval number [4] 316962 0
2023-062

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

Contacts
Principal investigator
Name 118886 0
A/Prof Serene (Sze Lin) Yoong
Address 118886 0
Swinburne University of Technology John St, Hawthorn VIC 3122
Country 118886 0
Australia
Phone 118886 0
+61 3 49246122
Fax 118886 0
Email 118886 0
[email protected]
Contact person for public queries
Name 118887 0
Noor (Nina) Imad
Address 118887 0
Swinburne University of Technology John St, Hawthorn VIC 3122
Country 118887 0
Australia
Phone 118887 0
+61 0434626008
Fax 118887 0
Email 118887 0
[email protected]
Contact person for scientific queries
Name 118888 0
Noor (Nina) Imad
Address 118888 0
Swinburne University of Technology John St, Hawthorn VIC 3122
Country 118888 0
Australia
Phone 118888 0
+61 0434626008
Fax 118888 0
Email 118888 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?




Results publications and other study-related documents

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