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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
17/03/2020
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 sustain scheduled physical activity across the school week a multi-strategy sustainability intervention will be offered to schools. The 12-month intervention delivered across 4 school terms will consist of the following:

1. Sustainability support: Schools will have access to a project officer that will contact school Principals initially to conduct a face-to face meeting, followed by regular telephone or email contact with in-school champions (once per school term) over 12 months to facilitate sustainability actions, identify and co-develop potential solutions to address barriers and monitor progress.

2. In-school champions: School principals will nominate 1-2 school champions as key contacts, to motivate and lead co-ordination of sustainability support strategies. School champions will attend 1 x 6hr face-to-face training workshop delivered by trained project officers where they will receive: resources including example schedules, physical activity policies, manuals that support the teaching of PE; assistance with continuing to schedule weekly PE, sport and other physical activity; integrating their school's physical activity policy into their strategic plan; developing a sustainability action and school champion handover / training plan; and navigating the online program portal. Email reminders will be sent to in-school champions to monitor adherence when intervention milestones are due to be completed i.e. school physical activity policy, integration of school's physical activity policy into their strategic plan, online resources presented to classroom teachers, sustainability action plan inclusive of a school champion handover / training plan developed. Project officer records will also be used to monitor intervention fidelity.

3. Executive support: Project officers will work with school executives to facilitate embedding of the physical activity policy within the schools’ existing school plans. The embedding of the school physical activity practices will enable schools to goal set and facilitate performance feedback to schools. School principals will be asked to demonstrate support for the sustained implementation of the physical activity policy and related programs via their regular communication processes with staff (e.g. staff meetings).

4. Training for classroom teachers: Schools will be provided online training materials and resources developed by the research team that will be presented to all staff by in-school champions during staff meetings or other relevant professional learning opportunities. These materials are designed to increase their knowledge and facilitate discussion among teachers to maintain their weekly scheduling of physical activity. Only in-school champions will be required to access and complete the training on the online portal.

5. Building on existing communities of practice in schools: Project officers will work with school champions to develop peer teacher networks for each stage group (K-2; 3-4; 5-6) designed to improve professional practice and teaching standards to sustain physical activity scheduling.
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 mean weekly minutes of physical activity scheduled by primary school teachers at 12 and 24 month follow-up compared to baseline. Teachers will provide their weekly class schedule reporting the minutes of physical activity scheduled.
Timepoint [1] 321955 0
Baseline, 12 months and 24 months post baseline (primary outcome)
Secondary outcome [1] 376793 0
The proportion of primary school teachers meeting the recommended physical activity guidelines at 12 and 24 month follow-up compared to baseline. Teachers will provide their weekly class schedule reporting the minutes of physical activity scheduled, as per the primary outcome.
Timepoint [1] 376793 0
Baseline, 12 months and 24 months post baseline
Secondary outcome [2] 380291 0
The difference in mean weekly minutes of energisers scheduled by primary school teachers at 12 and 24 month follow-up compared to baseline. Teachers will provide their weekly class schedule reporting the minutes of physical activity scheduled, as per the primary outcome.
Timepoint [2] 380291 0
Baseline, 12 months and 24 months post baseline
Secondary outcome [3] 380292 0
Mediator factors hypothesised to underpin any sustainability strategy effects. Questions from the validated Integrated Sustainability Framework (ISF) tool will be asked in a survey completed by classroom teachers at 12 and 24 month follow-up to assess these factors.
Timepoint [3] 380292 0
12 months and 24 months post baseline
Secondary outcome [4] 381085 0
Acceptability of the sustainability support strategies. Questions from the validated Integrated Sustainability Framework (ISF) tool will be asked in a survey completed by classroom teachers at 12 and 24 month follow-up to assess the acceptability of support strategies.
Timepoint [4] 381085 0
12 months and 24 months post baseline
Secondary outcome [5] 381086 0
Cost effectiveness will be calculated from the perspective of the NSW government. Compared to usual practice, the incremental costs associated with the development and implementation of the sustainability support strategies will be calculated. Resource use categories will include personnel costs, materials and printing. Personnel costs included opportunity costs for the delivery of support strategies. Project records relating to intervention delivery, including costs, will be kept throughout the trial. Cost effectiveness will be reported as the mean incremental cost per compliant school. Uncertainty intervals will be calculated reflecting variation in cost and outcome at the school level.
Timepoint [5] 381086 0
12 months and 24 months post baseline

Eligibility
Key inclusion criteria
Primary schools that have previously received support to increase their scheduling of physical activity within the Hunter New England local health district will be invited to participate.
Minimum age
18 Years
Maximum age
No limit
Gender
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; iii) schools who's average weekly minutes of physical activity scheduled has decreased since they previously received support; and iv) 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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
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
Address [1] 304266 0
Locked Bag 10
Wallsend NSW 2287
Australia
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)
Address [2] 305206 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [2] 305206 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 assist teachers to sustain the amount of physical activity scheduled across the school week. Schools will be provided professional development, resources, time and access to a support officer to make these changes. Approximately 50 primary schools in Hunter New England 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

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
nicole.nathan@health.nsw.gov.au
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
nicole.nathan@health.nsw.gov.au
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
nicole.nathan@health.nsw.gov.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?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5640 0
Ethical approval
Citation [1] 5640 0
Link [1] 5640 0
Email [1] 5640 0
nicole.nathan@health.nsw.gov.au
Other [1] 5640 0
Type [2] 6984 0
Ethical approval
Citation [2] 6984 0
Link [2] 6984 0
Email [2] 6984 0
Other [2] 6984 0
Summary results
No Results