Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000393752
Ethics application status
Approved
Date submitted
11/02/2022
Date registered
8/03/2022
Date last updated
25/01/2023
Date data sharing statement initially provided
8/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Activated OSHC on physical activity and screen time in children attending Outside School Hours Care (OSHC)
Scientific title
Activated OSHC: The effect of a multi-site guideline implementation randomised controlled trial on physical activity and screen time in children attending Outside School Hours Care (OSHC).
Secondary ID [1] 306268 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 325018 0
excessive recreational screen time 325019 0
Condition category
Condition code
Public Health 322456 322456 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The newly developed Australian Outside School Hours Care (OSHC) physical activity and screen time guidelines are intended to support children to achieve 15 minutes of physical activity before school and 30 minutes after school by scheduling 45 minutes and 90 minutes respectively of opportunity for active play. Screen time scheduling should be limited to no more than 30 minutes during before school care and no more than 60 minutes during after school care. “Activated OSHC” is an online training and accreditation program, aimed at improving adherence to the guidelines. The Activated OSHC program provides the following custom-designed resources:
a) “Becoming an Activated OSHC” how-to guide: This guide describes the process of completing the components to become an “Activated OSHC” (i.e., all staff to complete training modules, develop an approved physical activity, and screen time policy). It is expected that the OSHC director and OSHC educators will read the “how-to guide”. The “how-to guide” takes approximately 25 minutes to read.

b) Online training resources: A series of four online training modules using written information, interactive activities, short videos and quizzes will be provided.
1. Importance of Change describes the benefits of becoming an “Activated OSHC”. It describes the OSHC physical activity and screen time guidelines, the benefits of physical activity for children, and the importance of staff role-modelling of healthy physical activity behaviours. It identifies and addresses barriers and enablers that OSHC educators face when trying to get children to engage in more physical activity.
2. Making physical activity fun describes how to make physical activity fun and increase physical activity scheduling, including practical tips on increasing children's participation (e.g., avoiding lines or elimination games) and enabling children to choose how to be active (e.g., which games and how they're played).
3. Savouring screen time describes how to reduce screen time (e.g., when to schedule screen time) and how to provide active screen-based games rather than passive, sedentary screens. It also describes how to inform and involve families in the new scheduling changes.
4. Becoming an Activated OSHC examines staff knowledge of the OSHC physical activity and screen time guidelines, including scheduling, guideline limits, and ways to increase physical activity and reduce screen time.

c) Posters: Printable posters reminding staff, children and families about the guidelines will be provided for display in OSHC services. It is recommended that services use at least one poster, located in a high traffic area, in direct view of children and staff. The posters will have a strong visual focus, with limited text. The purpose of the posters is to remind and reinforce the new physical activity and screen time guidelines for OSHC.

d) Family communication resources: OSHC services will receive printable resources (brochures plus newsletter-suited text) they can use to help families understand OSHC programming changes, and support integration into positive physical activity and screen time practices at home. Services will be encouraged to hand out the resources to all families during the intervention period. The brochure will take approximately 3 minutes to read, and the newsletter content will take approximately 30 seconds to read.

After completing the baseline assessments, participants in the intervention group will be emailed the web address to the Activated OSHC website. The email will include directions on how to complete the Activated OSHC training modules, and a video link to demonstrate use of the website. The training modules are self-paced and enable users to save their progress and return to the website as work capacity allows. Each module will take approximately 15 minutes to complete (60 minutes in total). OSHC Directors and Educators will be encouraged to complete the training. The online training modules are not intended to be time structured program so that it enables services flexibility to complete the training according to their scheduling, staffing and other commitments (e.g. National accreditation assessments). Instead, services will be encouraged to complete the training within 3 months of starting the study; with a reminder sent at 3 months if not completed. At the end of the study, website analytics including number of logins and module completions, and views of videos/content will be used to monitor use of resources
Intervention code [1] 322688 0
Behaviour
Comparator / control treatment
Waitlist control group: The control group will be waitlisted for the duration of the 12-month study. No restrictions regarding concomitant training and resources will be applied. The control group will receive access to the "Activated OSHC" materials (Activated OSHC Manual, online training platform, posters, and communication resources) at the end of 12 months.
Control group
Active

Outcomes
Primary outcome [1] 330431 0
The proportion of services meeting OSHC physical activity and screen time guidelines will be assessed using an OSHC director-reported instrument previously developed and validated by the research team.
Timepoint [1] 330431 0
Baseline
3 months after baseline
12 months after baseline (primary endpoint)
Secondary outcome [1] 406177 0
Children’s physical activity and screen time behaviour will be measured using the System for Observing Play and Leisure Activity in Youth (SOPLAY) direct observation tool. Two assessors conduct continuous visual scans of children's play zones for an entire care session to describe the conditions of each play zone (e.g., whether it has physical activity equipment present) and the number of children engaging in sedentary activities, walking or vigorous activities. The directly observed data will be used to calculate the proportion of OSHC sessions spent in physical activity and recreational screen time.
Timepoint [1] 406177 0
Baseline
3 months after baseline
12 months after baseline
Secondary outcome [2] 406178 0
Educators’ support of children’s physical activity will be collected using the System for Observing Staff Promotion of Activity and Nutrition (SOSPAN) direct observation tool. Alongside each SOPLAY visual scan, a scan is performed categorising the presence and behaviour of staff in relation to physical activity (engaged, instructing, promoting, discouraging, withholding, disabling behaviours, or off-task). Data will be used to determine the proportion of care sessions that OSHC educators demonstrate physical activity supporting behaviours.
Timepoint [2] 406178 0
Baseline
3 months after baseline
12 months after baseline
Secondary outcome [3] 406179 0
Implementation process outcomes:
Determinants of implementation behaviour will be measured using purpose-designed survey items (mapped onto the Theoretical Domains Framework) that assess various domains relating to the implementation of physical activity and screen time in OSHC (knowledge, skills, role and identity, beliefs about capabilities, beliefs about consequences, intentions, environmental context and resources, social influences, behavioural regulation).
Timepoint [3] 406179 0
Baseline
3 months after baseline
12 months after baseline
Secondary outcome [4] 406180 0
Acceptability: OSHC directors in the intervention group (n=96) will complete purpose-designed survey items at 3 and 12 months evaluating specific components of the program, for example, which components they used, how important the components were (5-point Likert scale), and how satisfied they were with components (5-point Likert scale).
Timepoint [4] 406180 0
3 months after baseline
12 months after baseline
Secondary outcome [5] 406181 0
Preference using Discrete Choice Experiment: OSHC directors in the intervention group (n=96) will complete a purpose-designed discrete choice experiment, where they will be asked to indicate their preferences for a series of hypothetical intervention packages. Each question will present two hypothetical intervention packages, which vary in a range of attributes (i.e., what is provided in the intervention). Participants choose which intervention (intervention 1 or intervention 2) they prefer.
Timepoint [5] 406181 0
12 months after baseline - intervention group only
Secondary outcome [6] 406182 0
Resource Use:
Logs of how the online resources were used will be downloaded at 12 months from the intervention services.
Timepoint [6] 406182 0
12 months after baseline – intervention group only
Secondary outcome [7] 406679 0
Cost-effectiveness outcome using a purpose-designed survey. The survey provides information on the number of staff employed, hours spent on Activated OSHC, cost of resources and any other costs incurred with the Activated OSHC program.
Timepoint [7] 406679 0
12 months after baseline – intervention group only

Eligibility
Key inclusion criteria
Eligible OSHC services must provide both before school care and after school care. Additionally, they must be located within 120 km of Adelaide, Perth, or Newcastle, or be in one of the following regional areas: SA: Riverland, Eyre and Western, Far North, Yorke and MidNorth; NSW: Central Coast and Hunter region; WA: Augusta-Margaret River, Busselton, Bunbury. For practical reasons, convenience sampling will be applied in regional areas.
At each OSHC service, there are 2 participant groups:
1. Among eligible OSHC services, all directors who speak English and have internet access will be eligible to participate.
2. All children at participating OSHC services will be eligible to participate.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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 computer program (REDCap) will be used to randomise OSHC services to either the intervention or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
OSHC services will be randomised in a 1:1 allocation ratio to either the intervention or control group. A computer-generated randomisation table will be imported into REDcap for implementation. Randomisation will be stratified based on state and SES tertile. Block randomisation will be used to ensure group allocation is equal.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be performed following the intention to treat principles, with the OSHC service as the unit of analysis.
Primary analysis:
1. Mixed effects multivariable logistic regression will be used to determine group x time changes in the proportion of intervention and control services with programming schedules that meet the OSHC sector physical activity and screen time guidelines. The model will be adjusted by the stratification factors (state and SES tertile). If assumptions warrant it, multiple imputation will be used to replace missing data.
Secondary analyses:
1. Mixed effects Poisson regression will be used to determine group x time changes in children's physical activity.
2. Mixed effects Poisson regression will be used to determine group x time changes in children's screen time behaviours.
3. Cost effectiveness will be analysed using the incremental cost effectiveness ratio, based on improvements in the primary outcome. An assessment of the sensitivity of the results obtained with respect to variation in measured resource use, effectiveness and/or unit costs will be undertaken using appropriate one way and multiway sensitivity analyses.
4. Quantitative acceptability/feasibility data will be analysed descriptively.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
22/08/2022
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
192
Accrual to date
42
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA

Funding & Sponsors
Funding source category [1] 310619 0
Government body
Name [1] 310619 0
Medical Research Future Fund (MRFF), Australian Government Department of Health - PPHR Initiative 2020 Maternal First 2000 Days and Childhood Health grant
Country [1] 310619 0
Australia
Funding source category [2] 310753 0
Government body
Name [2] 310753 0
National Health and Medical Research Council (NHMRC) Partnership Grant
Country [2] 310753 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 311824 0
University
Name [1] 311824 0
University of Newcastle
Address [1] 311824 0
Wallsend Health Campus,
Booth Building 1st Floor
University Drive
Callaghan NSW 2308
Country [1] 311824 0
Australia
Secondary sponsor category [2] 311983 0
University
Name [2] 311983 0
University of Western Australia
Address [2] 311983 0
PO Box 855
West Perth, WA 6872
Country [2] 311983 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310223 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 310223 0
Ethics committee country [1] 310223 0
Australia
Date submitted for ethics approval [1] 310223 0
22/12/2021
Approval date [1] 310223 0
27/04/2022
Ethics approval number [1] 310223 0
Ethics committee name [2] 310330 0
Approved
Ethics committee address [2] 310330 0
Ethics committee country [2] 310330 0
Australia
Date submitted for ethics approval [2] 310330 0
30/04/2022
Approval date [2] 310330 0
20/06/2022
Ethics approval number [2] 310330 0
Ethics committee name [3] 310331 0
Approved
Ethics committee address [3] 310331 0
Ethics committee country [3] 310331 0
Australia
Date submitted for ethics approval [3] 310331 0
30/04/2022
Approval date [3] 310331 0
25/05/2022
Ethics approval number [3] 310331 0

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

Contacts
Principal investigator
Name 116906 0
Prof Carol Maher
Address 116906 0
University of South Australia
City East Campus
GPO Box 2471
Adelaide SA 5001
Country 116906 0
Australia
Phone 116906 0
+61 8 8302 2315
Fax 116906 0
Email 116906 0
[email protected]
Contact person for public queries
Name 116907 0
Carol Maher
Address 116907 0
University of South Australia
City East Campus
GPO Box 2471
Adelaide SA 5001
Country 116907 0
Australia
Phone 116907 0
+61 8 8302 2315
Fax 116907 0
Email 116907 0
[email protected]
Contact person for scientific queries
Name 116908 0
Carol Maher
Address 116908 0
University of South Australia
City East Campus
GPO Box 2471
Adelaide SA 5001
Country 116908 0
Australia
Phone 116908 0
+61 8 8302 2315
Fax 116908 0
Email 116908 0
[email protected]

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
No additional documents have been identified.