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Trial registered on ANZCTR
Registration number
ACTRN12617000669392
Ethics application status
Approved
Date submitted
5/05/2017
Date registered
9/05/2017
Date last updated
9/05/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
Primary school Physical Education and Physical Literacy (PEPL) support system: a quasi randomised controlled trial
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Scientific title
Introduction of a trained Physical Education Physical Literacy (PEPL) coach into a group of primary schools: its effect on school culture, the teaching of physical education and on physical literacy of the students. A quasi-randomised controlled trial in Geelong in the state of Victoria, Australia
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Secondary ID [1]
291827
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Nil
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Universal Trial Number (UTN)
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Trial acronym
PEPL
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Linked study record
ACTRN12615000066583
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Health condition
Health condition(s) or problem(s) studied:
physical inactivity
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Condition category
Condition code
Public Health
302589
302589
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0
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Epidemiology
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention involves the appointment of a trained physical educator whom we refer to as a “Physical Education Physical Literacy (PEPL) coach”. The coach will use a socio-ecological framework approach to improve physical activity levels and physical literacy at the child (participant) level by targeting barriers at the teacher, school, family, and community level. Barriers to physical activity and physical literacy will be identified using surveys and questionnaires completed at the start of the study.
The PEPL coach will be assigned to a cluster of 8 geographically linked schools on a full-time working basis for the 10 month study period.
Examples of day to day activities of the Coachr will include:
1) Teacher level: providing assistance, resources, modelling, support and professional development for generalist classroom teachers to improve the planning, quality and delivery of physical education classes.
2) Family level: Encouraging parents (through educational materials) to provide more opportunities and support for their child to by physically active
3) School level: assisting schools to develop and/or improve their school physical activity policy and climate
4) Community level: encouraging sports clubs to receive new participants and facilitating community role models to visit schools to promote physical activity.
Adherence to the intervention will be monitored using school and teacher attendance records
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Intervention code [1]
297979
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Behaviour
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Intervention code [2]
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Lifestyle
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Comparator / control treatment
The Control is a group of 8 schools of similar socioeconomic, teaching structure and size which continue their usual practice of physical education and sport
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Control group
Active
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Outcomes
Primary outcome [1]
302004
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Quality and quantity of physical education and sport taught by the generalist classroom teacher. Assessed by SOFIT (System For Observing Fitness Instruction Time)
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Assessment method [1]
302004
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Timepoint [1]
302004
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10 months after the quasi-randomisation
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Primary outcome [2]
302005
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Classroom teacher perception of personal PE teaching competence,and confidence. Assessed by a customised questonnaire
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Assessment method [2]
302005
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Timepoint [2]
302005
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10 months after quasi-randomisation
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Primary outcome [3]
302006
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Physical activity during Physical Education classes assessed by accelerometers
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Assessment method [3]
302006
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Timepoint [3]
302006
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10 months after quasi-randomisation
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Secondary outcome [1]
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Student perceived competence in physical education and sport. Assessed by CY-PSPP (Physical Self-Perception Profile) questionnaire
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Assessment method [1]
334504
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Timepoint [1]
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10 months after quasi-randomisation
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Secondary outcome [2]
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Day to day physical activity patterns assessed by accelerometers
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Assessment method [2]
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Timepoint [2]
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10 months after quasi-randomisation
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Secondary outcome [3]
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Student enjoyment of physical education and sport. Assessed by PACES (Physical Activity Enjoyment Scale) questionnaire
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Assessment method [3]
334573
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Timepoint [3]
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10 months after quasi-randomisation
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Eligibility
Key inclusion criteria
Healthy children in government public schools
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Minimum age
10
Years
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Maximum age
12
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
None
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Schools in the study are separated geographically to such and extent that teachers and students are not likely to collaborate and share ideas;
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Our model fits within the general framework of general linear mixed model; similar to the model associated with publications concerning our previous quasi-randomized control trial, the LOOK (Lifestyle of our Kids) Project (search Telford RD for papers)
The design structure involves three levels: Level 1 is the School; Level 2 is the Child within school; Level 3 involves the repeat observations (i.e. longitudinal observations) on a child.
Consider the variable MVPA (Moderate and Vigorous Physical Activity)as an example of a response variable of interest
MVPA = constant + Group effect+ SES effect + + school random effect + Sex effect + Sex.Group interaction +child random effect + Year effect + Sex.Year effect + Group.Year effect + possible interactions between fixed effects + within-child random error
Group in the intervention or control group
The Group.Year effect is the effect of the intervention
Restricted maximum likelihood is used to estimate variance components and weighted least squares for estimating fixed effects. Statistical significance of effects is assessed by calculating adjusted Wald statistics. General model checking procedures will be routinely used to identify aberrant data and to check the model assumptions.
With regard to sample size calculations and statistical assumptions, Professor Ross Cunningham (research team member and statistical consultant) makes the following comments: 1) It is not possible to undertake a formal power analysis with sufficient precision for the current study 2) Statistical knowledge gained from the LOOK study indicates that 16 schools will ensure internal validity of the design i.e. there is sufficient information to estimate the 'experimental' error and intervention and control effects with adequate precision 3) At least 20 children in each school is needed to estimate school effects with high precision. Window of opportunity for testing at the start and the end of the year precludes greater numbers of schools and students.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
6/02/2017
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Date of last participant enrolment
Anticipated
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Actual
27/02/2017
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Date of last data collection
Anticipated
9/02/2018
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Actual
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Sample size
Target
350
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Accrual to date
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Final
340
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Canberra
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Address [1]
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Locked Bag 1,
University of Canberra,
ACT 2601
AUSTRALIA
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Country [1]
296326
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Australia
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Primary sponsor type
University
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Name
University of Canberra
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Address
Locked Bag 1,
University of Canberra,
ACT 2601
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]
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Address [1]
295333
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Country [1]
295333
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
297556
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University of Canberra Human Research Ethics Committee
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Ethics committee address [1]
297556
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University of Canberra
University Drive
Bruce
ACT 2617
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Ethics committee country [1]
297556
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Australia
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Date submitted for ethics approval [1]
297556
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18/11/2016
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Approval date [1]
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25/01/2017
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Ethics approval number [1]
297556
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16-216
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Summary
Brief summary
The Physical Education Physical Literacy (PEPL) project evaluates a support system designed to assist primary schools to create a physically active culture, increase student opportunities for physical activity, and to enhance the content and delivery of physical education. This study continues on from a previous research project conducted in Victoria (ACTRN12615000066583)
The system is guided by a PEPL coach - an expert physical educator working in a network of 8 schools who tailors the support system to meet individual school needs. The objectives of the PEPL coach include:
1) Develop a school climate that understands the benefits of PEPL for student learning and development
2) Provide in-class lesson modelling and professional development for the generalist classroom teacher
3) Increase opportunities for students to take part in physical education and physical literacy activities outside of physical education time
4) To develop relationships between schools, community organisations and sporting clubs
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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 Rohan Telford
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Address
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University of Canberra
University Drive
Bruce
ACT 2617
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Country
74426
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Australia
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Phone
74426
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+61 2-62068883
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Fax
74426
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Email
74426
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[email protected]
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Contact person for public queries
Name
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Dr Rohan Telford
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Address
74427
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University of Canberra
University Drive
Bruce
ACT 2617
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Country
74427
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Australia
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Phone
74427
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+61 2-62068883
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Fax
74427
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Email
74427
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[email protected]
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Contact person for scientific queries
Name
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Dr Rohan Telford
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Address
74428
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University of Canberra
University Drive
Bruce
ACT 2617
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Country
74428
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Australia
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Phone
74428
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+61 2-62068883
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Fax
74428
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Email
74428
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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.
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