Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 291827 0
Nil
Universal Trial Number (UTN)
Trial acronym
PEPL
Linked study record
ACTRN12615000066583

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 303142 0
Condition category
Condition code
Public Health 302589 302589 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 297979 0
Behaviour
Intervention code [2] 297980 0
Lifestyle
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
Control group
Active

Outcomes
Primary outcome [1] 302004 0
Quality and quantity of physical education and sport taught by the generalist classroom teacher. Assessed by SOFIT (System For Observing Fitness Instruction Time)
Timepoint [1] 302004 0
10 months after the quasi-randomisation
Primary outcome [2] 302005 0
Classroom teacher perception of personal PE teaching competence,and confidence. Assessed by a customised questonnaire
Timepoint [2] 302005 0
10 months after quasi-randomisation
Primary outcome [3] 302006 0
Physical activity during Physical Education classes assessed by accelerometers
Timepoint [3] 302006 0
10 months after quasi-randomisation
Secondary outcome [1] 334504 0
Student perceived competence in physical education and sport. Assessed by CY-PSPP (Physical Self-Perception Profile) questionnaire
Timepoint [1] 334504 0
10 months after quasi-randomisation
Secondary outcome [2] 334572 0
Day to day physical activity patterns assessed by accelerometers
Timepoint [2] 334572 0
10 months after quasi-randomisation
Secondary outcome [3] 334573 0
Student enjoyment of physical education and sport. Assessed by PACES (Physical Activity Enjoyment Scale) questionnaire
Timepoint [3] 334573 0
10 months after quasi-randomisation

Eligibility
Key inclusion criteria
Healthy children in government public schools
Minimum age
10 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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;
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
6/02/2017
Date of last participant enrolment
Anticipated
Actual
27/02/2017
Date of last data collection
Anticipated
9/02/2018
Actual
Sample size
Target
350
Accrual to date
Final
340
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 296326 0
University
Name [1] 296326 0
University of Canberra
Country [1] 296326 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
Locked Bag 1,
University of Canberra,
ACT 2601
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 295333 0
None
Name [1] 295333 0
Address [1] 295333 0
Country [1] 295333 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297556 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 297556 0
Ethics committee country [1] 297556 0
Australia
Date submitted for ethics approval [1] 297556 0
18/11/2016
Approval date [1] 297556 0
25/01/2017
Ethics approval number [1] 297556 0
16-216

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

Contacts
Principal investigator
Name 74426 0
Dr Rohan Telford
Address 74426 0
University of Canberra
University Drive
Bruce
ACT 2617
Country 74426 0
Australia
Phone 74426 0
+61 2-62068883
Fax 74426 0
Email 74426 0
[email protected]
Contact person for public queries
Name 74427 0
Rohan Telford
Address 74427 0
University of Canberra
University Drive
Bruce
ACT 2617
Country 74427 0
Australia
Phone 74427 0
+61 2-62068883
Fax 74427 0
Email 74427 0
[email protected]
Contact person for scientific queries
Name 74428 0
Rohan Telford
Address 74428 0
University of Canberra
University Drive
Bruce
ACT 2617
Country 74428 0
Australia
Phone 74428 0
+61 2-62068883
Fax 74428 0
Email 74428 0
[email protected]

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.