Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000372987
Ethics application status
Approved
Date submitted
9/03/2020
Date registered
17/03/2020
Date last updated
4/08/2023
Date data sharing statement initially provided
17/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of an intervention to sustain primary schools’ implementation of a state-wide physical activity policy
Scientific title
Evaluation of a multi-component intervention to sustain primary schools’ implementation of a state-wide physical activity policy
Secondary ID [1] 299805 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Activity 315179 0
Condition category
Condition code
Public Health 313497 313497 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To support schools to sustain scheduled physical activity, in particular daily classroom energisers (i.e., short 5-10 minutes class time physical activity breaks), across the school week a multi-strategy sustainability intervention will be offered to schools.

1. Obtain executive support: Executive support will be obtained from educational leaders at the commencement of the study period to illustrate their endorsement of schools scheduling energisers every day. Support will also be communicated to the schools’ staff through an endorsement email template; and the school community through a framed certificate and fence sign to display highlighting them as an ‘Energiser school’.

2. Prompts and support to school champions: Project officers will provide email support to school champions throughout the intervention period to: i) remind teachers to schedule daily energisers; ii) address any new barriers that emerge with school champions; and iii) identify when and if school champion turnover occurs. If a new school champion is identified, project officers will contact them via email, welcoming school champions to their new role and providing them with relevant materials and resources for their role.

3. Provision of resources: A range of resources will be provided to teachers to motivate and remind them to schedule energisers each day, including timetable templates, infographics, resource cards and case studies of successful Energiser schools. Schools will also be provides with electronic resources which can be provided to parents and carers for newsletters and kinder orientation material which explains the importance of energisers and that they are an Energiser school.
Intervention code [1] 316056 0
Prevention
Intervention code [2] 316057 0
Lifestyle
Intervention code [3] 316058 0
Behaviour
Comparator / control treatment
Usual practice (no intervention) and reactive support – consisting of usual school practices towards physical activity in the school community, which may or may not include professional development opportunities for teachers, resources, and/or school policies. Schools will be provided with minimal reactive support if required. They will be offered the intervention after the 24 month follow up assessments have occurred.
Control group
Active

Outcomes
Primary outcome [1] 321955 0
The difference in the change in mean minutes of Energisers implemented by classroom teachers across the school day, assessed via class logbooks completed by teachers (i.e., self-report) at 12 and 24-month follow-up compared to baseline.
Timepoint [1] 321955 0
Baseline, 12 months and 24 months post baseline (primary outcome)
Secondary outcome [1] 380291 0
Difference in the change in mean minutes of overall physical activity and the individual components that make up total physical activity, including sport, physical education (PE), Energisers and other planned activities (e.g., active lessons) implemented by classroom teachers across the school week, assessed via class logbooks completed by teachers (i.e., self-report) at baseline, 12 and 24-month follow-up.
Timepoint [1] 380291 0
Baseline, 12 months and 24 months post baseline
Secondary outcome [2] 380292 0
Factors perceived to be influential to sustained scheduling of daily energisers from the perspective of both executives (i.e., principals) and implementers (i.e., teachers) will be assessed via Principal and teacher surveys.
Timepoint [2] 380292 0
Baseline, 12 months and 24 months post baseline
Secondary outcome [3] 381085 0
Perceived acceptability of the sustainability support strategies provided will be assessed via the Principal and teacher surveys.
Timepoint [3] 381085 0
12 months and 24 months post baseline
Secondary outcome [4] 381086 0
A prospective economic analysis measuring the incremental cost and outcomes of the sustainability strategies will be undertaken. Resource use for the intervention and usual practice will be prospectively identified and measured from project records (staff and consumables). Direct costs associated with the intervention are anticipated to include labour and program materials. Incremental cost will be calculated as the difference between intervention and usual care cost. The primary outcome for the economic analysis will align to the trial outcome, which is the between-group difference in the change in mean minutes of Energisers scheduled across the school day at 24 months follow-up compared to baseline. A ‘within trial’ economic analysis will assess program value by comparing incremental costs and benefits at the school level across the study arms. Uncertainty intervals will be calculated for the mean incremental cost result and incremental cost effectiveness ratio using non-parametric bootstrapping.
Timepoint [4] 381086 0
12 months and 24 months post baseline
Secondary outcome [5] 422544 0
Perceived feasibility of the sustainability support strategies provided previously will be assessed via the Principal and teacher surveys.
Timepoint [5] 422544 0
12 months and 24 months post baseline
Secondary outcome [6] 422545 0
Perceived appropriateness of the sustainability support strategies provided previously will be assessed via the Principal and teacher surveys.
Timepoint [6] 422545 0
12 months and 24 months post baseline
Secondary outcome [7] 425123 0
Data regarding the operational characteristics of schools will be collected using a combination of surveys of the school website as well as survey items completed by school principals and classroom teachers. Project officer records and survey items will be used to record delivery of sustainability support strategies, and exposure of individual schools and teachers to such strategies.
Timepoint [7] 425123 0
12 months and 24 months post baseline

Eligibility
Key inclusion criteria
Primary schools that have previously received implementation support to increase their scheduling of daily energisers across the school week within the Hunter New England, Illawarra Shoalhaven, Murrumbidgee and Norther New South Wales Local Health Districts will be invited to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
i) Schools catering exclusively for children requiring specialist care; ii) schools who have not previously received support to increase their scheduling of physical activity; and iii) schools already involved in a physical activity trial will be ineligible. School sectors that do not provide approval for study participation will also be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following baseline data collection and school recruitment, schools will be randomised in a 1:1 ratio to either an intervention or control group via a central randomisation process by computer. Block randomisation will be employed to ensure group allocation is approximately equal. Data collectors will be blind to group allocation. Due to the nature of the intervention school staff will be aware of their group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician will use a computerised random number function to randomise schools in a 1:1 ratio
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be undertaken under an intention to treat framework. Analysis of outcomes at 12-month follow-up will provide evidence of any immediate impact of the intervention. The 24-month follow-up will provide evidence of long-term sustainability of policy implementation and will represent the primary end-point. Teacher scheduling of Energisers will be the unit of analysis. Between-group differences in the change from baseline of the primary outcome will be assessed at each time-point using linear mixed models. Models will include fixed effects for treatment group (intervention vs control), time (baseline, 12-month, 24-month), a time-by-treatment group interaction term and pre-specified characteristics related to the outcome. A random level intercept for school will be included to account for the clustered design of the study. A random intercept for teacher clustered within school will also be included to account for potential repeated measures. All available data will be used in the analysis with missing data addressed via the linear mixed models assuming the data is missing at random. Teacher’s data will be analysed according to the experimental group their school was randomised to. All statistical tests will be 2 tailed with alpha of 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/06/2023
Actual
5/06/2023
Date of last participant enrolment
Anticipated
18/08/2023
Actual
Date of last data collection
Anticipated
9/06/2025
Actual
Sample size
Target
40
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304266 0
Government body
Name [1] 304266 0
Hunter New England Population Health
Country [1] 304266 0
Australia
Funding source category [2] 305206 0
Government body
Name [2] 305206 0
National Health and Medical Research Council (NHMRC) - Partnership Grant (APP1190373)
Country [2] 305206 0
Australia
Funding source category [3] 313997 0
Government body
Name [3] 313997 0
Department of Health and Aged Care, Medical Research Future Fund – Clinical Researcher Investigator Grant (APP1194785)
Country [3] 313997 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Locked Bag 10
Wallsend NSW 2287
Australia
Country
Australia
Secondary sponsor category [1] 304510 0
None
Name [1] 304510 0
Address [1] 304510 0
Country [1] 304510 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304721 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 304721 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 304721 0
Australia
Date submitted for ethics approval [1] 304721 0
17/02/2020
Approval date [1] 304721 0
18/02/2020
Ethics approval number [1] 304721 0
2019/ETH12353
Ethics committee name [2] 304723 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 304723 0
University Drive
Callaghan NSW 2308
Ethics committee country [2] 304723 0
Australia
Date submitted for ethics approval [2] 304723 0
19/02/2020
Approval date [2] 304723 0
26/02/2020
Ethics approval number [2] 304723 0
H-2008-0343
Ethics committee name [3] 304724 0
State Education Research Applications Process (SERAP)
Ethics committee address [3] 304724 0
NSW Department of Education
GPO Box 33 SYDNEY NSW 2001
Ethics committee country [3] 304724 0
Australia
Date submitted for ethics approval [3] 304724 0
25/02/2020
Approval date [3] 304724 0
26/02/2020
Ethics approval number [3] 304724 0
2017184

Summary
Brief summary
The aim of this randomised controlled trial is to provide sustainability support to schools to sustain classroom teacher’s scheduling of daily Energisers (i.e., short 5–10 minute bouts of physical activity that occur during class-time) across the school week from baseline to 12 and 24-month follow-up. Schools will be provided a series of support strategies including, obtaining executive support, prompts and support to school champions, and provision of resources. Approximately 40 primary schools in Hunter New England, Illawarra Shoalhaven, Murrumbidgee and Northern New South Wales Local Health Districts will be randomly allocated to either an intervention group or a control group. The final trial endpoint is 24 months post baseline.
Trial website
Trial related presentations / publications
Public notes
We submitted an ethics amendment to the Hunter New England Human Research Ethics Committee on the 25/04/2022 to add Murrumbidgee, Illawarra Shoalhaven and Northern NSW local health district sites to the study which is reflected in the updates in this registration. This was approved on the 23/05/2022.

We submitted a further ethics amendment to the Hunter New England Human Research Ethics Committee on the 29/10/2022 to make minor changes to the trial processes, change the primary trial outcome to scheduling of mean minutes of daily Energisers and modify the sustainability support strategies delivered to intervention schools, which is reflected in the updates in this registration. This was approved on the 1/11/2022.

Contacts
Principal investigator
Name 97998 0
Dr Nicole Nathan
Address 97998 0
Hunter New England Population Health
Longworth Avenue
Wallsend, NSW 2287
Country 97998 0
Australia
Phone 97998 0
+61 2 49246257
Fax 97998 0
+ 61 2 49246209
Email 97998 0
[email protected]
Contact person for public queries
Name 97999 0
Dr Nicole Nathan
Address 97999 0
Hunter New England Population Health
Longworth Avenue
Wallsend, NSW 2287
Country 97999 0
Australia
Phone 97999 0
+61 2 49246257
Fax 97999 0
+ 61 2 49246209
Email 97999 0
[email protected]
Contact person for scientific queries
Name 98000 0
Dr Nicole Nathan
Address 98000 0
Hunter New England Population Health
Longworth Avenue
Wallsend, NSW 2287
Country 98000 0
Australia
Phone 98000 0
+61 2 49246257
Fax 98000 0
+ 61 2 49246209
Email 98000 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?




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.