Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001265369
Ethics application status
Approved
Date submitted
24/08/2017
Date registered
1/09/2017
Date last updated
28/05/2021
Date data sharing statement initially provided
14/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of an intervention to facilitate the implementation of scheduled physical activity in NSW primary schools.
Scientific title
Evaluation of the efficacy of a multi-component implementation support intervention on mean minutes of physical activity scheduled by primary school teachers each week
Secondary ID [1] 292712 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Activity 304477 0
Condition category
Condition code
Public Health 303813 303813 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To support schools implement scheduled physical activity across the school week a 12 month (4 school term) multi-component implementation support strategy will be offered to schools. Baseline measurements will occur prior to the intervention beginning in Term 4. The intervention will consist of the following;

1. 1 x 5hr face to face training delivered by trained PE teachers for primary school stage coordinators to help with the scheduling of PE, sport and other physical activity will occur at the start of the intervention (i.e. Term 4) to align with schools' planning phase for the following year;
2. 1 x 2hr face to face professional development for all teachers to increase the quality and activity of PE and sport will occur at the beginning of the school year (i.e. Term 1);
3. Resources including example schedules, policy, manuals that support the teaching of PE that are existing resources of the Department of Education or developed specificially for the trial and pedometers for teachers to use with students to increase activity in PE and sport;
4. On-going support via telephone and email and an on-line portal to support the implementation of the policy.
Intervention code [1] 298954 0
Prevention
Intervention code [2] 298955 0
Lifestyle
Intervention code [3] 298956 0
Behaviour
Comparator / control treatment
Usual practice (no intervention) – 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. They will be offered the intervention after the 18 month follow up assessments have occurred.
Control group
Active

Outcomes
Primary outcome [1] 303173 0
The mean minutes of physical activity scheduled by primary school teachers across the school week measured via teachers’ class timetable. Teachers will provide their weekly class schedule reporting the minutes of physical activity scheduled
Timepoint [1] 303173 0
Baseline, 12 months (primary outcome) and 18 months post baseline
Secondary outcome [1] 338126 0
Students’ physical activity- mean physical activity counts per minute will be measured objectively using wrist-worn accelerometers, by students in grade 2-3 at all schools for 5 consecutive school days. Data will be analysed for whole school day as well as segmented.
Timepoint [1] 338126 0
Baseline and 12 months post baseline
Secondary outcome [2] 338127 0
Teacher physical activity - teachers mean physical activity counts per minute will be measured objectively using wrist-worn accelerometers, for 5 consecutive days and complete selected items from the NSW Adult Population Health Survey (NSW Centre for Epidemiology and Evidence 2015). Data will be analysed for whole school day as well as segmented
Timepoint [2] 338127 0
Baseline and 12 months post-baseline
Secondary outcome [3] 338128 0
Teacher wellbeing - teachers complete the Perceived Stress Scale (Cohen 1983).
Timepoint [3] 338128 0
Baseline and 12 months post-baseline
Secondary outcome [4] 338130 0
Student’s on-task behaviour- teachers will complete selected items from the Teaching and Learning International Survey (OECD 2010)
Timepoint [4] 338130 0
Baseline and 12 months post-baseline
Secondary outcome [5] 338131 0
Cost-effectiveness- 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 implementation 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] 338131 0
12 months post-baseline
Secondary outcome [6] 338252 0
Students’ physical activity- mean minutes of MVPA per day will be measured objectively using wrist-worn accelerometers, by students in grade 2-3 at all schools for 5 consecutive school days. Data will be analysed for whole school day as well as segmented.
Timepoint [6] 338252 0
Baseline and 12 months post baseline
Secondary outcome [7] 338253 0
Teacher physical activity - teachers mean minutes of MVPA will be measured objectively using wrist-worn accelerometers, for 5 consecutive days and complete selected items from the NSW Adult Population Health Survey (NSW Centre for Epidemiology and Evidence 2015). Data will be analysed for whole school day as well as segmented
Timepoint [7] 338253 0
Baseline and 12 months post baseline

Eligibility
Key inclusion criteria
Primary schools within the Hunter New England and North Coast Diocese will be invited to participate.
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 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
Completed
Date of first participant enrolment
Anticipated
1/10/2017
Actual
1/10/2017
Date of last participant enrolment
Anticipated
20/12/2017
Actual
1/03/2018
Date of last data collection
Anticipated
Actual
1/07/2019
Sample size
Target
60
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297356 0
Government body
Name [1] 297356 0
Hunter New England Population Health
Country [1] 297356 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] 296332 0
None
Name [1] 296332 0
Address [1] 296332 0
Country [1] 296332 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298452 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 298452 0
Ethics committee country [1] 298452 0
Australia
Date submitted for ethics approval [1] 298452 0
Approval date [1] 298452 0
15/05/2017
Ethics approval number [1] 298452 0
6/7/26/4.04
Ethics committee name [2] 298453 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 298453 0
Ethics committee country [2] 298453 0
Australia
Date submitted for ethics approval [2] 298453 0
Approval date [2] 298453 0
17/07/2017
Ethics approval number [2] 298453 0
H-2008-0343
Ethics committee name [3] 298454 0
Catholic Schools Office – Maitland Newcastle Diocese
Ethics committee address [3] 298454 0
Ethics committee country [3] 298454 0
Australia
Date submitted for ethics approval [3] 298454 0
26/07/2017
Approval date [3] 298454 0
10/08/2017
Ethics approval number [3] 298454 0
2012277

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

Contacts
Principal investigator
Name 77138 0
Dr Nicole Nathan
Address 77138 0
Hunter New England Population Health
Longworth Avenue
Wallsend, NSW 2287
Country 77138 0
Australia
Phone 77138 0
+61 2 49246257
Fax 77138 0
+ 61 2 49246209
Email 77138 0
[email protected]
Contact person for public queries
Name 77139 0
Nicole Nathan
Address 77139 0
Hunter New England Population Health
Longworth Avenue
Wallsend, NSW 2287
Country 77139 0
Australia
Phone 77139 0
+ 61 2 49246257
Fax 77139 0
+ 61 2 49246209
Email 77139 0
[email protected]
Contact person for scientific queries
Name 77140 0
Nicole Nathan
Address 77140 0
Hunter New England Population Health
Longworth Avenue
Wallsend, NSW 2287
Country 77140 0
Australia
Phone 77140 0
+ 61 2 49246257
Fax 77140 0
+ 61 2 49246209
Email 77140 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
240Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA cluster randomised controlled trial of an intervention to increase the implementation of school physical activity policies and guidelines: study protocol for the physically active children in education (PACE) study.2019https://dx.doi.org/10.1186/s12889-019-6492-z
EmbaseThe impact of an implementation intervention that increased school's delivery of a mandatory physical activity policy on student outcomes: A cluster-randomised controlled trial.2022https://dx.doi.org/10.1016/j.jsams.2021.12.005
N.B. These documents automatically identified may not have been verified by the study sponsor.