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Trial registered on ANZCTR


Registration number
ACTRN12619001229167
Ethics application status
Approved
Date submitted
31/07/2019
Date registered
5/09/2019
Date last updated
16/06/2021
Date data sharing statement initially provided
5/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preparing an effective school-based physical activity implementation strategy for scale-up: a randomized noninferiority trial.
Scientific title
Is an adapted school-based physical activity implementation strategy statistically noninferior to the original effective intervention in increasing the mean minutes of weekly physical activity scheduled by primary school teachers?
Secondary ID [1] 298892 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a follow-up to registration number: ACTRN12617001265369.

Health condition
Health condition(s) or problem(s) studied:
physical activity
 313861 0
Condition category
Condition code
Public Health 312274 312274 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adapted PACE
In a 2018 RCT, the multi-strategy Physically Active Children in Education (PACE) intervention was effective in supporting schools to implement a state-wide physical activity policy. Intervention schools scheduled significantly more physical activity across the school week compared to control schools. However, PACE may not be suitable for dissemination in its original format and a low intensity variation may be noninferior (and more scalable). The low intensity PACE intervention will consist of the following;
1. 1 × 5hr face-to-face training delivered by project officers (accredited by the state educational authority) for existing primary school staff who volunteer to take on the role of in-school champion (ISC) to help with the scheduling of PE, sport and other physical activity. Occurs at the start of the intervention (term 4) to align with schools’ planning phase for the upcoming school year.
2. 1 × 1hr face-to-face professional development for all teachers, delivered by the ISC at the beginning of the school year (term 1) with the goal to increase teachers scheduling of physical activity during the school day.
3. Resources either pre-existing from the Department of Education or developed specifically for the trial, such as an online portal, physical activity packs, example schedules, example policies, and manuals that support the teaching of PE.
4. 1 initial outreach to ISC and principals via e-mail or telephone delivered by project officers.
5.Project officers further support policy implementation via on-going distance communication (i.e., telephone and email) as well as the on-line portal.
Intervention code [1] 315162 0
Prevention
Intervention code [2] 315163 0
Lifestyle
Intervention code [3] 315164 0
Behaviour
Comparator / control treatment
Original PACE
The comparator will consist of the original PACE intervention including the following strategies;
1. 1 × 5hr face-to-face training delivered by project officers for existing primary school staff who volunteer to take on the role of in-school champion (ISC) to help with the scheduling of PE, sport and other physical activity. Occurs at the start of the intervention (term 4) to align with schools’ planning phase for the upcoming school year.
2. 1 × 1hr face-to-face professional development for all teachers, delivered by the project officers at the beginning of the school year (term 1) with the goal to increase teachers scheduling of physical activity during the school day.
3. Resources either pre-existing from the Department of Education or developed specifically for the trial, such as an online portal, physical activity packs, example schedules, example policies, and manuals that support the teaching of PE.
4. 1 face-to-face ISC outreach visit and one face-to-face principal outreach visit delivered by project officers.
5. Project officers further support policy implementation via on-going face-to-face communication in addition to telephone, e-mail and the on-line portal.
Control group
Active

Outcomes
Primary outcome [1] 320911 0
The mean minutes of physical activity scheduled by primary school teachers across the school week as measured by teachers’ daily activity log-books. Teachers will provide their weekly class schedule reporting the minutes of physical activity scheduled.
Timepoint [1] 320911 0
Baseline and 12 month follow-up
Secondary outcome [1] 373315 0
Mean minutes of planned PE, sport and other structured activities scheduled by primary school teachers across the school week as measured via teachers’ class timetable. Teachers will provide their weekly class schedule including reporting the minutes of each type of physical activity scheduled (i.e., planned PE, sport and other structured activities).
Timepoint [1] 373315 0
Baseline and 12 month follow-up
Secondary outcome [2] 373317 0
Cost effectiveness (i.e., the mean incremental cost per school) will be calculated from the perspective of the NSW government. The cost difference associated with the implementation of PACE will be calculated between the high intensity and low intensity versions of the intervention. Resource use categories will include personnel costs, materials and printing as detailed via project records maintained throughout the trial. Uncertainty intervals will be calculated reflecting variation in cost and outcome at the school level.
Timepoint [2] 373317 0
12 month follow-up
Secondary outcome [3] 373894 0
The implementation outcome of reach will be measured using process data recorded by project officers and surveys from teachers, principals and in-school champions. Process data records and surveys were designed specifically for the preceding PACE trial (registration ACTRN12617001265369) and adapted for use in this trial.
Timepoint [3] 373894 0
12 month follow-up
Secondary outcome [4] 374427 0
The implementation outcome of adoption will be measured using process data recorded by project officers and surveys from teachers, principals and in-school champions. Process data records and surveys were designed specifically for the preceding PACE trial (registration ACTRN12617001265369) and adapted for use in this trial.
Timepoint [4] 374427 0
12 month follow-up
Secondary outcome [5] 374428 0
The implementation outcome of implementation will be measured using process data recorded by project officers and surveys from teachers, principals and in-school champions. Process data records and surveys were designed specifically for the preceding PACE trial (registration ACTRN12617001265369) and adapted for use in this trial.
Timepoint [5] 374428 0
12 month follow-up
Secondary outcome [6] 374429 0
The perceived importance of PACE strategies will be qualitatively measured using interviews of in-school champions and project officers; and focus groups of teachers. Semi-structured interview guides and focus group guides were developed specifically for this study.
Timepoint [6] 374429 0
12 month follow-up

Eligibility
Key inclusion criteria
Primary schools within the Hunter New England (HNE) region.
Minimum age
6 Years
Maximum age
11 Years
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. 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, schools were randomised in a 1:1 ratio to either the low intensity or high intensity intervention arm via a central randomisation process by computer. Block randomisation ensured group allocation was approximately equal. Data collectors and school staff are blind to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician used a computerised random number function to randomise schools in a 1:1 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Noninferiority will be established if the difference in mean minutes of weekly scheduled physical activity by teachers in the high intensity arm and the low intensity arm is less than a pre-determined noninferiority margin.

The noninferiority margin for this study was set using fixed parameters from the prior PACE pilot and effectiveness trial. The resulting noninferiority margin is 17.9 mean minutes of weekly scheduled physical activity by teachers. This maintains 50% of the intervention effect.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/09/2018
Date of last participant enrolment
Anticipated
Actual
25/03/2019
Date of last data collection
Anticipated
20/12/2019
Actual
20/12/2019
Sample size
Target
50
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303433 0
Government body
Name [1] 303433 0
Hunter New England Population Health
Country [1] 303433 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] 303485 0
None
Name [1] 303485 0
Address [1] 303485 0
Country [1] 303485 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303966 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 303966 0
Ethics committee country [1] 303966 0
Australia
Date submitted for ethics approval [1] 303966 0
21/09/2018
Approval date [1] 303966 0
Ethics approval number [1] 303966 0
06/07/26/4.05
Ethics committee name [2] 303967 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 303967 0
Ethics committee country [2] 303967 0
Australia
Date submitted for ethics approval [2] 303967 0
Approval date [2] 303967 0
03/12/2018
Ethics approval number [2] 303967 0
H-2008-0343
Ethics committee name [3] 303968 0
Catholic Schools Office – Maitland Newcastle Diocese
Ethics committee address [3] 303968 0
Ethics committee country [3] 303968 0
Australia
Date submitted for ethics approval [3] 303968 0
Approval date [3] 303968 0
10/08/2017
Ethics approval number [3] 303968 0
2012277
Ethics committee name [4] 303969 0
NSW Department of Education School Policy and Information Management (SERAP)
Ethics committee address [4] 303969 0
Ethics committee country [4] 303969 0
Australia
Date submitted for ethics approval [4] 303969 0
Approval date [4] 303969 0
05/12/2018
Ethics approval number [4] 303969 0
2017184

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

Contacts
Principal investigator
Name 95402 0
Dr Nicole Nathan
Address 95402 0
Hunter New England Population Health
Longworth Avenue
WALLSEND, NSW 2287
Country 95402 0
Australia
Phone 95402 0
+61 2 49246257
Fax 95402 0
+ 61 2 49246490
Email 95402 0
Nicole.Nathan@health.nsw.gov.au
Contact person for public queries
Name 95403 0
Nicole Nathan
Address 95403 0
Hunter New England Population Health
Longworth Avenue
WALLSEND, NSW 2287
Country 95403 0
Australia
Phone 95403 0
+61 2 49246257
Fax 95403 0
+ 61 2 49246490
Email 95403 0
Nicole.Nathan@health.nsw.gov.au
Contact person for scientific queries
Name 95404 0
Nicole Nathan
Address 95404 0
Hunter New England Population Health
Longworth Avenue
WALLSEND, NSW 2287
Country 95404 0
Australia
Phone 95404 0
+61 2 49246257
Fax 95404 0
+ 61 2 49246490
Email 95404 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3643Ethical approval  cassandra.lane1@health.nsw.gov.au Available upon request



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.