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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.
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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
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Secondary ID [1]
292712
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Physical Activity
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Condition category
Condition code
Public Health
303813
303813
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
298954
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Prevention
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Intervention code [2]
298955
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Lifestyle
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Intervention code [3]
298956
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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Baseline, 12 months (primary outcome) and 18 months post baseline
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Secondary outcome [1]
338126
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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.
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Assessment method [1]
338126
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Timepoint [1]
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Baseline and 12 months post baseline
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Secondary outcome [2]
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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
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Assessment method [2]
338127
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Timepoint [2]
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Baseline and 12 months post-baseline
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Secondary outcome [3]
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Teacher wellbeing - teachers complete the Perceived Stress Scale (Cohen 1983).
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Assessment method [3]
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Timepoint [3]
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Baseline and 12 months post-baseline
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Secondary outcome [4]
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Student’s on-task behaviour- teachers will complete selected items from the Teaching and Learning International Survey (OECD 2010)
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Assessment method [4]
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Timepoint [4]
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Baseline and 12 months post-baseline
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Secondary outcome [5]
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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.
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Assessment method [5]
338131
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Timepoint [5]
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12 months post-baseline
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Secondary outcome [6]
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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.
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Assessment method [6]
338252
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Timepoint [6]
338252
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Baseline and 12 months post baseline
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Secondary outcome [7]
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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
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Assessment method [7]
338253
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Timepoint [7]
338253
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Baseline and 12 months post baseline
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Eligibility
Key inclusion criteria
Primary schools within the Hunter New England and North Coast Diocese will be invited to participate.
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Minimum age
6
Years
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Maximum age
11
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
Nil
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/10/2017
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Actual
1/10/2017
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Date of last participant enrolment
Anticipated
20/12/2017
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Actual
1/03/2018
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Date of last data collection
Anticipated
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Actual
1/07/2019
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Sample size
Target
60
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Accrual to date
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Final
62
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Hunter New England Population Health
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Address [1]
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Locked Bag 10
Wallsend NSW 2287
Australia
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Country [1]
297356
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Australia
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Primary sponsor type
Government body
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Name
Hunter New England Population Health
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Address
Locked Bag 10
Wallsend NSW 2287
Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
296332
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Address [1]
296332
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Country [1]
296332
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
298452
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
298452
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Locked Bag 1 New Lambton NSW 2305
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Ethics committee country [1]
298452
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Australia
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Date submitted for ethics approval [1]
298452
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Approval date [1]
298452
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15/05/2017
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Ethics approval number [1]
298452
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6/7/26/4.04
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Ethics committee name [2]
298453
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University of Newcastle Human Research Ethics Committee
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Ethics committee address [2]
298453
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University Drive Callaghan NSW 2308
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Ethics committee country [2]
298453
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Australia
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Date submitted for ethics approval [2]
298453
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Approval date [2]
298453
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17/07/2017
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Ethics approval number [2]
298453
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H-2008-0343
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Ethics committee name [3]
298454
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Catholic Schools Office – Maitland Newcastle Diocese
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Ethics committee address [3]
298454
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1/841 Hunter Street, Newcastle West 2302
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Ethics committee country [3]
298454
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Australia
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Date submitted for ethics approval [3]
298454
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26/07/2017
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Approval date [3]
298454
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10/08/2017
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Ethics approval number [3]
298454
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2012277
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Summary
Brief summary
The aim of this randomised control trial is to assist teachers to increase the amount of scheduled physical activity time they provide across a school week. Schools will be provided professional development, resources, time and access to a support officer to make these changes. Sixty primary schools in HNE and Mid north coast LHD’s will be randomly allocated to either an intervention group or a control group. The final trial endpoint is 18 months.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Nicole Nathan
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Address
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Hunter New England Population Health
Longworth Avenue
Wallsend, NSW 2287
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Country
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Australia
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Phone
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+61 2 49246257
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Fax
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+ 61 2 49246209
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Email
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nicole.nathan@hnehealth.nsw.gov.au
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Contact person for public queries
Name
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Nicole Nathan
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Address
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Hunter New England Population Health
Longworth Avenue
Wallsend, NSW 2287
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Country
77139
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Australia
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Phone
77139
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+ 61 2 49246257
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Fax
77139
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+ 61 2 49246209
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Email
77139
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nicole.nathan@hnehealth.nsw.gov.au
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Contact person for scientific queries
Name
77140
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Nicole Nathan
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Address
77140
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Hunter New England Population Health
Longworth Avenue
Wallsend, NSW 2287
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Country
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Australia
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Phone
77140
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+ 61 2 49246257
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Fax
77140
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+ 61 2 49246209
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Email
77140
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nicole.nathan@hnehealth.nsw.gov.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
nicole.nathan@hnehealth.nsw.gov.au
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
A 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.
2019
https://dx.doi.org/10.1186/s12889-019-6492-z
Embase
The impact of an implementation intervention that increased school's delivery of a mandatory physical activity policy on student outcomes: A cluster-randomised controlled trial.
2022
https://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.
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