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
5/08/2022
Date data sharing statement initially provided
5/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the feasibility, acceptability and potential impact of utilising a strategy to increase the sustainment of outdoor free play programs 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
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
The acceptability of the sustainability strategy using a quantitative measure capturing information related to the acceptability (attitude towards the sustainability strategy, burden, ethicality of the strategy, coherence, effectiveness, self-efficacy) of the sustainability strategy. These items are underpinned by the Theoretical Framework of Acceptability, a validated framework to assess the acceptability of healthcare interventions from the perspectives of intervention delivers and recipients. This survey includes 7 items where the NS will be asked to rate their level of agreement with the acceptability items on a Likert scale from 1 to 5, where a higher score indicates higher acceptability. This measure will also include an additional item for NS to provide further comments on the acceptability of the sustainability strategy. These responses will be collected via a semi-structured 15-minute interview with a member of the research team or via an online survey completed by the Nominated Supervisor.
Timepoint [1] 331222 0
6-months post-intervention commencement
Primary outcome [2] 331223 0
Assess the feasibility of trial methods for a fully powered RCT. This will be assessed using project records to report consent rate, percentage of missing data from completion of the FPR, comparison of consent/non-consenter characteristics and attrition rate. This will be done by the research team documenting this data during recruitment and intervention delivery in a spreadsheet.
Timepoint [2] 331223 0
6-month post-intervention commencement
Primary outcome [3] 331675 0
The feasibility of the sustainability strategy using the Feasibility of Intervention quantitative Measure including 3 items where the NS will be asked to rate their level of agreement with the feasibility items on a Likert scale from 1 to 5 where 1 = strongly disagree, 2=disagree, 3 = no opinion, 4 = agree and 5 = strongly agree. This measure will also include an additional item for NS to provide any further comments on the feasibility of the sustainability strategy. This questionnaire will capture information related to the feasibility (practicality, ease of implementation, suitability of sustainability strategy for everyday use) of the sustainability strategy and its fit in the daily routine at the service. These questions are adapted from the Feasibility of Intervention measure and responses which will be collected via a semi-structured 15-minute interview with a member of the research team or via an online survey completed by the Nominated Supervisor.
Timepoint [3] 331675 0
6-month post-intervention commencement
Secondary outcome [1] 409232 0
Sustainment of an indoor-outdoor free play routine using a Free Play Record (self-reported) measure created by the research team. Data on the minutes children are provided with indoor-only, indoor-outdoor and outdoor-only free play during a randomly selected week will be collected via the FPR developed to assess service implementation of indoor-outdoor free play policies and the number of minutes of outdoor play. The FPR is adapted from existing ECEC measures and is similar to those used in primary schools. The FPR asks services to report on the amount of time children spend in the indoor only, indoor-outdoor, and outdoor only environments during free play periods at the service. The FPR will be provided to the nominated supervisors or room leaders of the ECEC service electronically via email by the research team, at baseline and follow up. The room leader/NS(s) will be asked to fill out the record for each session of free play throughout the day across the selected week (5 consecutive days) and return the completed record to the research team.
Timepoint [1] 409232 0
Baseline. 6-month and 12-month post-intervention commencement
Secondary outcome [2] 409233 0
Assess the barriers and facilitators to sustainment of the EBI (indoor-outdoor free play) using a measure developed by the research team. This will be collected via a semi-structured 15-minute interview with a member of the research team or via an online survey completed by the Nominated Supervisor. This survey collects information regarding the programs, policies and practices related to physical activity for children at the service to better understand what factors influence the ongoing delivery of PA and nutrition EBIs in the ECEC setting. This survey consists of 9 items where the NS will be asked to rate their level of agreement with these items on a Likert scale from 1 to 5. Where 1 = completely disagree, 2=disagree, 3 = neither agree nor disagree, 4 = agree and 5 = completely agree.
Timepoint [2] 409233 0
Baseline, 6-months post-intervention commencement
Secondary outcome [3] 409680 0
A cost consequence analysis will be conducted by calculating the amount of time spent by the health promotion officers on developing resources, administration work and the delivery of the intervention, multiplied by their hourly wage. We will also assess cost from a services perspective by asking nominated supervisors to report any estimated costs from participating in the intervention.
Timepoint [3] 409680 0
12-months post-intervention commencement
Secondary outcome [4] 412517 0
Fidelity will be assessed using the sustainability action plan developed by the research team (internal measure) which will be completed by both the health promotion officer and the opinion leader during the scheduled support calls throughout the 6-month intervention period to determine how many sustainability strategies out of the minimum 6 were put into practice.
Timepoint [4] 412517 0
6-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. Are implementing any indoor-only free play (defined as implementing more than 30 minutes of indoor-only free play per day) at the time of completion of a telephone interview by the research team (in response to Department of Education guidance to introduce more outdoor free play)
2. Do not understand English
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, a statistician independent of the study will randomly allocate services in a 1:1 ratio to either receiving the sustainability strategy or the usual care control group. and services will be notified of their trial allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician independent of the study will generate sequence allocation using a computerised random number function. Block randomisation in groups of four will be used to ensure group allocation is 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
All statistical analysis will be undertaken in 2022 SAS Analytics. All data will be analysed using descriptive statistics. Chi-square analyses will be used to compare characteristics of consenting and non-consenting services, as well as service characteristics between intervention and control groups at baseline. The main data collection point is at 6 months post-baseline. Separate analyses will be performed at each follow-up time point (6 and 12 months) for the FPR. The continuous outcome will be synthesised as total minutes of indoor only free play, indoor-outdoor and outdoor only minutes. FPR data will be analysed using a negative binomial regression model.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2022
Actual
Date of last participant enrolment
Anticipated
19/09/2022
Actual
Date of last data collection
Anticipated
29/09/2023
Actual
Sample size
Target
20
Accrual to date
Final
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
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
Locked Bag No: 1
New Lambton NSW 2305
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
University Dr, Callaghan NSW 2305
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
John St, Hawthorn VIC 3122
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

Summary
Brief summary
Early Childhood Education and Care (ECEC) settings are a particularly important setting to reach young children with physical activity (PA) promotion efforts. As children aged 3-5 years spend an average of 25-35 hours a week in ECEC services, these settings provide a broad reach for intervention delivery to increase child activity at a population level. In light of the lack of sustained implementation documented following the introduction of outdoor free play public health policies, the aim of this study is to assess the feasibility, acceptability, and potential impact of a sustainability strategy to increase the sustainment of recent indoor-outdoor free play practice in ECEC services. The 6-month intervention will target ECEC service Nominated Supervisors (NS), and an educator responsible for supporting the implementation of physical activity programs in the ECEC service. Specifically, services will be supported to continue to deliver the evidence-based intervention; indoor-outdoor free play through the development of eight sustainability strategies. This will be compared to a control group that does not receive the sustainability strategy. It is hypothesised that the sustainability strategy will be feasible to implement, acceptable to ECEC services, and will produce sustained implementation of indoor-outdoor free play compared to the control group.
Trial website
Trial related presentations / publications
Public notes
Aim: To assess the feasibility, acceptability, and potential impact of a sustainability strategy to increase the sustainment of recent indoor-outdoor free play practice in ECEC services.
Design: The study will employ a pilot, parallel-group randomised controlled trial design with 20 ECEC services located in NSW, Australia who implementing indoor-outdoor free play routines for most of the day since July 2021 (i.e., defined as equal to or less than 30 minutes of indoor-only free play per day). ECEC services will be randomised to receive either the sustainability strategy intervention or a usual care control. ECEC services and staff delivering the intervention will not be blinded to group allocation, however, outcome assessors and those conducting data cleaning and data analysis will remain blinded to service allocation.

Intervention: The 6-month intervention will target ECEC service Nominated Supervisors (NS), and an educator responsible for supporting the implementation of physical activity programs in the ECEC service. . Specifically, services will be supported to continue to deliver the evidence-based intervention; indoor-outdoor free play through the development of eight sustainability strategies.

Outcome: The primary outcomes are to; i) describe the acceptability, feasibility and potential impact of a sustainability strategy on the sustainment of indoor-outdoor free play routines, ii) to assess the feasibility of trial methods to inform the conduct of a fully powered RCT assessing the impact of a sustainability strategy on the sustainment of indoor-outdoor free play practices in ECEC services and iii) barriers and facilitators to the delivery sustainment of indoor-outdoor free play routines. The NS within the service will report on the acceptability and feasibility of the sustainability strategy at the 6-month follow up time point using a quantitative survey developed by the research team.

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
syoong@swin.edu.au
Contact person for public queries
Name 118887 0
Mrs 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
nimad@swin.edu.au
Contact person for scientific queries
Name 118888 0
Mrs 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
nimad@swin.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?




Results publications and other study-related documents

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