Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000510842
Ethics application status
Approved
Date submitted
1/03/2021
Date registered
30/04/2021
Date last updated
30/04/2021
Date data sharing statement initially provided
30/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Is a low-intensity, low-cost implementation strategy (ePACE) as effective in increasing teachers’ implementation of classroom physical activity as the previously established Physically Active Children in Education (PACE) implementation intervention?
Scientific title
A two-arm cluster-randomised non-inferiority trial to assess whether a less intensive and lower cost implementation strategy to increase teachers’ implementation of classroom physical activity is non-inferior to an effective, full-scale implementation strategy.
Secondary ID [1] 303206 0
Nil known
Universal Trial Number (UTN)
U1111-1262-7971
Trial acronym
ePACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Activity 320345 0
Condition category
Condition code
Public Health 318259 318259 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This multi-component intervention seeks to support teachers’ scheduling and delivery of ‘Energisers’ (i.e., short 5–10 minute bouts of physical activity that occur during class-time). The intervention is built on extensive evidence from previous phases of the Physically Active Children in Education (PACE) program (described below as the comparator arm for this trial).

Following baseline data collection and randomisation, participating schools will receive all intervention materials and resources required to support the implementation of the physical activity policy at their school.

The adapted version of the program (i.e., ePACE) will consist of:

1. Executive support: At the study outset, principals will receive an information statement (specific to participation in this trial) via email outlining the importance and benefits of Energisers and be encouraged to show their support by communicating (e.g., via newsletters, assemblies and staff meetings) their expectations regarding the implementation of Energisers to the broader school community (i.e., staff, students and parents). In addition, there will be one follow-up email to principals to request a summary of how this was achieved.

2. In-school champion support: Following school enrollment, participating schools will be encouraged to nominate an in-school champion who drives the participation of teachers in the program and facilitates access to online learning (see point 3). Nominated in-school champions will be emailed a manual with guidance relating to their role (specific to this study) and asked to continue to promote the implementation of physical activity at their schools for the duration of the trial (i.e., 12 months) and beyond if possible.

3. Online learning: Participants allocated to this group will receive access to an online portal including educational content and resources and self-directed course modules specific to implementing the physical activity policy consisting of sample schedules and policies (i.e., developed specifically for the trial), action planning templates and instructions, short videos and quizzes and short activities that boost self-efficacy and motivation to implement Energisers. Following completion of baseline data collection and randomisation, participants will receive access to the online portal and be asked to complete all online course modules within 10 weeks. It is estimated that this will take no more than 3 hours (Note: participants can save their progress and return later if needed). Access to the online portal (i.e., resources and course), however, will be perpetual. That is, participants will be able to return to the portal for resources at any time during the 12-month study period and beyond. Website analytics will be used to monitor the uptake and usage of the online portal and course. We will encourage in-school champions to send a gentle reminder to participating teachers (after approximately 4 weeks; if deemed appropriate) to promote the completion of this component.

4. Equipment pack vouchers: Nominated in-school champions who have completed their online course will be able to request voucher codes from the research team to purchase basic sports equipment that may be used to facilitate the delivery of Energisers. These vouchers will have no expiry date and can be used when ordering directly from our nominated supplier who will deliver specifically branded sports equipment packs (i.e., including study logos) to schools.

5. Ongoing support: Participating schools will be able to seek support from project officers with any matters related to program implementation (via telephone and/or email).
Intervention code [1] 319511 0
Prevention
Intervention code [2] 319512 0
Lifestyle
Intervention code [3] 319513 0
Behaviour
Comparator / control treatment
The comparator arm will receive the multi-component strategy (i.e., PACE) that has previously been found to be effective in improving teachers' scheduling and delivery of ‘Energisers’. Specifically, the PACE program will include:

1. Executive support: At the study outset, principals will receive an information statement (specific to participation in this trial) via email outlining the importance and benefits of Energisers and be encouraged to show their support by communicating (e.g., via newsletters, assemblies and staff meetings) their expectations regarding the implementation of Energisers to the broader school community (i.e., staff, students and parents). In addition, there will be one follow-up email to principals to request a summary of how this was achieved.

2. In-school champion support: Following school enrollment, participating schools will be encouraged to nominate an in-school champion who will lead the implementation of the program. In-school champions will also receive an initial 15-minute support session via telephone or video chat following baseline data collection and randomisation, and be offered ongoing consultation with allocated project officers to address common implementation barriers. In-school champions will be asked to continue to promote the implementation of physical activity at their schools for the duration of the trial (i.e., 12 months) and beyond if possible.

3. In-school champion training: Following completion of baseline data collection and randomisation, nominated in-school champions will be invited to a face-to-face training day delivered by trained PE teachers, to help with the scheduling of physical activity across the school week (in alignment with the school’s planning for each term of the year)*. Attendance at the workshop will occur within approximately 10 weeks of randomisation. (Note: Training days will be scheduled during term time under consideration of usual activities). In addition, trained in-school champions will then be tasked with the delivery of one 1–2h teacher information and training session (held as part of the earliest possible school staff meeting, which typically occurs at the beginning of a new school term) and one 15-min follow-up teachers support session (during a subsequent staff meeting; approximately 10-12 weeks later).

4. Educational materials: School champions will receive a range of educational materials specific to implementing the physical activity policy consisting of sample schedules and policies, action planning templates and instructions (developed specifically for the trial).

5. Equipment pack vouchers: Nominated school champions will receive vouchers from the project team to purchase basic sports equipment that may be used to facilitate the delivery of Energisers. The research team will provide voucher codes to all in-school champions who attend the training day. These vouchers will have no expiry date and can be used when ordering directly from our nominated supplier who will deliver specifically branded sports equipment packs (i.e., including study logos) to schools.

6. Ongoing support: Participating schools will be able to seek support from project officers with any matters related to program implementation (via telephone and/or email).

* Face-to-face training days for in-school champions will be conducted online if local restrictions due to current outbreaks (i.e., virus pandemic) preclude face-to-face delivery.
Control group
Active

Outcomes
Primary outcome [1] 326240 0
Mean minutes of Energisers implemented by primary school teachers across the school week, assessed via class logbooks completed by teachers (i.e., self-report).
Timepoint [1] 326240 0
Baseline and 12 months after baseline
Secondary outcome [1] 390697 0
Mean minutes of total physical activity implemented by primary school teachers across the school week, inclusive of other forms of scheduled physical activity such as sport and physical education (PE), as well as Energisers and other planned activities (e.g., active lessons), assessed via class logbooks completed by teachers (i.e., self-report).
Timepoint [1] 390697 0
Baseline and 12 months after baseline
Secondary outcome [2] 390698 0
The costs associated with the development of the adapted program (ePACE) will be prospectively identified, measured and valued, as will the implementation costs for both ePACE and the original PACE program. Resource use categories will include personnel costs, materials and printing. Personnel costs will include opportunity costs for the delivery of support strategies. Project records relating to intervention delivery, including costs, will be kept throughout the trial. If ePACE is found to be non-inferior to the PACE program, a cost minimisation analysis will be undertaken to determine the intervention with the least cost. Uncertainty analysis will be undertaken for the estimated average cost of delivering both programs, reflecting variation in cost components across the sample.
Timepoint [2] 390698 0
Continuous throughout the 12-month study period.
Secondary outcome [3] 390702 0
Teacher-rated student engagement in class will be assessed using Lee & Reeve’s (2012) Teacher Rating Scale. This 4-item composite measure comprises behavioural, emotional, cognitive and agentic engagement.
Timepoint [3] 390702 0
Baseline and 12 months after baseline

Eligibility
Key inclusion criteria
We will include principals and teachers from primary schools in the Hunter New England region of New South Wales, Australia in this trial. Staff from all Government, Catholic, Central and Independent Primary Schools will be eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools catering exclusively for children requiring specialist care, and/or schools already involved in a physical activity trial will be ineligible.

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)
Baseline assessments will occur prior to the start of the intervention in Term 3 (i.e., July–September) of 2021. Following baseline data collection, schools will be stratified by local sector, school type (Government versus Non-Government Schools) and geographical location and randomly allocated in a 1:1 ratio to one of two intervention groups via a central computer-assisted randomisation process. Block randomisation will be employed to ensure group allocation is approximately equal. Data collectors will be blinded to group allocation. Due to the nature of the trial, participants 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 randomly allocate schools in a 1:1 ratio (i.e., 40 schools per arm).
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
The evaluation of the interventions will be based on a non-inferiority trial design and use a rolling recruitment method.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will assess whether the adapted version of the intervention (i.e., ePACE) is non-inferior to the original implementation intervention (i.e., PACE) with previously proven effectiveness. Non-inferiority will be established if the difference between the adapted and the original implementation intervention is less than the pre-specified non-inferiority margin of 8.3 minutes. The non-inferiority margin is based on results from our previous effectiveness trial, which maintains at least 50% of the original treatment effect of the original implementation intervention and is considered clinically meaningful.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/05/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
560
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307439 0
Government body
Name [1] 307439 0
Hunter New England Population Health
Country [1] 307439 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Locked Bag 10
Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 308112 0
University
Name [1] 308112 0
University of Newcastle
Address [1] 308112 0
University Drive
Callaghan NSW 2308
Country [1] 308112 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307520 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 307520 0
Ethics committee country [1] 307520 0
Australia
Date submitted for ethics approval [1] 307520 0
02/03/2021
Approval date [1] 307520 0
19/03/2021
Ethics approval number [1] 307520 0
06/07/26/4.04
Ethics committee name [2] 308226 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 308226 0
Ethics committee country [2] 308226 0
Australia
Date submitted for ethics approval [2] 308226 0
24/03/2021
Approval date [2] 308226 0
29/03/2021
Ethics approval number [2] 308226 0
H-2008-0343

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

Contacts
Principal investigator
Name 107530 0
Dr Nicole Nathan
Address 107530 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 107530 0
Australia
Phone 107530 0
+61 2 49246257
Fax 107530 0
Email 107530 0
nicole.nathan@health.nsw.gov.au
Contact person for public queries
Name 107531 0
Nicole Nathan
Address 107531 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 107531 0
Australia
Phone 107531 0
+61 2 49246257
Fax 107531 0
Email 107531 0
nicole.nathan@health.nsw.gov.au
Contact person for scientific queries
Name 107532 0
Nicole Nathan
Address 107532 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287
Country 107532 0
Australia
Phone 107532 0
+61 2 49246257
Fax 107532 0
Email 107532 0
nicole.nathan@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data and data dictionaries collected during the trial will be made available in de-identified form upon reasonable request, approved by the Principal Investigator.
When will data be available (start and end dates)?
Data will be available from 12 months after publication of the trial results, with no specified end date but adhering to terms and conditions of data retention.
Available to whom?
To anyone based on reasonable request, approved by the Principal Investigator.
Available for what types of analyses?
Analyses will be approved by the Principal Investigator, based on reasonable request.
How or where can data be obtained?
By request to the Principal Investigator, Dr Nicole Nathan
Nicole.Nathan@health.nsw.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10279Ethical approvalA copy of ethical approval can be obtained (once this is available) based on reasonable request. nicole.nathan@health.nsw.gov.au
10790Study protocolA copy of the study protocol can be obtained upon reasonable request (once published). If published open access, a DOI will be made available for this publication. nicole.nathan@health.nsw.gov.au
10791Informed consent formCopies of the participant consent forms can be obtained based on reasonable request. nicole.nathan@health.nsw.gov.au
10835Clinical study reportA copy of the study report can be obtained upon reasonable request (once published). If published open access, a DOI will be made available for this publication. nicole.nathan@health.nsw.gov.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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