ANZCTR - Registration

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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]

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

Condition category

Condition code

Public Health

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]

Baseline and 12 months after baseline

Secondary outcome [1]

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]

Baseline and 12 months after baseline

Secondary outcome [2]

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]

Continuous throughout the 12-month study period.

Secondary outcome [3]

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]

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]

Government body

Name [1]

Hunter New England Population Health

Address [1]

Locked Bag 10
Wallsend NSW 2287

Country [1]

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]

University

Name [1]

University of Newcastle

Address [1]

University Drive
Callaghan NSW 2308

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Locked Bag 1
New Lambton NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/03/2021

Approval date [1]

19/03/2021

Ethics approval number [1]

06/07/26/4.04

Ethics committee name [2]

The University of Newcastle Human Research Ethics Committee

Ethics committee address [2]

University Drive
Callaghan, NSW 2308

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

24/03/2021

Approval date [2]

29/03/2021

Ethics approval number [2]

H-2008-0343

Summary

Brief summary

The aim of this two-arm cluster-randomised controlled trial is to determine whether the less resource- and cost-intensive version of the PACE program (i.e., ePACE) is non-inferior with regards to increasing teachers’ implementation of classroom physical activity via Energisers, relative to the original PACE program. Eighty primary schools will be recruited to examine this.

In each of the two arms, teachers will receive support to increase the amount of physical activity time, in particular Energisers, they deliver across the school week. Schools in the ePACE program will receive executive support, access to an online portal, equipment pack vouchers and ongoing project officer support. The comparator (i.e., PACE) condition will include the original face-to-face in-school champion training, an educational session delivered to teachers by in-school champions as well as executive support, and information and resources to support implementation. Eighty primary schools will be randomly allocated to one of two intervention groups. The final trial endpoint is defined as 12 months after baseline.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Nicole Nathan

Address

Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287

Country

Australia

Phone

+61 2 49246257

Fax

[email protected]

Contact person for public queries

Name

Dr Nicole Nathan

Address

Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287

Country

Australia

Phone

+61 2 49246257

Fax

[email protected]

Contact person for scientific queries

Name

Dr Nicole Nathan

Address

Hunter New England Population Health
Locked Bag 10
Wallsend, NSW 2287

Country

Australia

Phone

+61 2 49246257

Fax

[email protected]

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
[email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Email
10279	Ethical approval	A copy of ethical approval can be obtained (once this is available) based on reasonable request.	[email protected]
10790	Study protocol	A 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.	[email protected]
10791	Informed consent form	Copies of the participant consent forms can be obtained based on reasonable request.	[email protected]
10835	Clinical study report	A 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.	[email protected]

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.

Trial Review

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Documents added automatically