Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000066583
Ethics application status
Approved
Date submitted
4/11/2014
Date registered
23/01/2015
Date last updated
23/01/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Revitalising physical education, sport and physical literacy in primary schools: a quasi-randomised controlled trial
Scientific title
Introduction of a trained physical literacy facilitator into a group of primary schools: its effect on the teaching of physical education and organization of sport by generalist classroom teachers; and effect on physical activity of the children. A quasi-randomised controlled trial in metropolitan and regional districts in the state of Victoria.
Secondary ID [1] 285770 0
Nil
Universal Trial Number (UTN)
Trial acronym
PPLS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 292848 0
obesity 292849 0
Condition category
Condition code
Public Health 293148 293148 0 0
Epidemiology
Diet and Nutrition 294252 294252 0 0
Obesity

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 Literacy Facilitator”. The facilitator 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 facilitator will be assigned to a cluster of approximately 6-10 geographically linked schools on a full-time working basis for the 10 month study period.
Examples of day to day activities of the Physical Literacy Facilitator will include:
1) Teacher level: providing assistance, resources, 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
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] 290093 0
Lifestyle
Intervention code [2] 290729 0
Behaviour
Comparator / control treatment
The Control is a group of 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] 293002 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] 293002 0
one year after the quasi-randomization
Primary outcome [2] 293003 0
Child perceived competence and enjoyment of physical education and sport. Assessed by CY-PSPP (Physical Self-Perception Profile) and PACES (Physical Activity Enjoyment Scale) questionnaires
Timepoint [2] 293003 0
one year after the quasi-randomization
Primary outcome [3] 293004 0
Classroom teacher perception of personal PE teaching competence, importance and enjoyment. Assessed by a customised questonnaire
Timepoint [3] 293004 0
one year after quasi-randomization
Secondary outcome [1] 310124 0
general day to day and school physical activity assessed by accelerometers
Timepoint [1] 310124 0
one year after quasi-randomization
Secondary outcome [2] 310125 0
body composition of children assessed by skinfold
Timepoint [2] 310125 0
one year after quasi-randomization
Secondary outcome [3] 311218 0
cardiovascular fitness of children assessed by the multi-stage fitness test
Timepoint [3] 311218 0
one year after quasi-randomization

Eligibility
Key inclusion criteria
healthy children in government public schools
Minimum age
6 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)
Quasi-randomization is limited to the level of schools. Of 16 schools in the western and north-western suburbs of Melbourne, principals and teachers of each school are invited to participate through meetings and discussion of the design, and provided with information sheets. Grade 5 children make up the sample of the school population to be tested before and after the intervention. Parents and guardians are provided with information sheets and consent forms signed prior to beginning the trial. Allocation involved contacting the holder of the allocation schedule who was "off site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A cross tabulation method will be used to determine which schools are quasi-randomly allocated to the intervention and control schools; as a pure random selection may introduce inadvertent bias. Variables considered are: School Size (>300 or < 300); specialist PE resident teacher or not; ethnicity (<30% or >30% ethnic backgrounds.
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;
All schools in the geographical area have include children from families of non English speaking ethnicity, mainly from middle-eastern countries.
Phase
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
Not yet recruiting
Date of first participant enrolment
Anticipated
2/02/2015
Actual
Date of last participant enrolment
Anticipated
25/02/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289835 0
Government body
Name [1] 289835 0
Victorian Department of Education and Early Childhood Development
Country [1] 289835 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] 288525 0
Government body
Name [1] 288525 0
Victorian Department of Education and Early Childhood Development
Address [1] 288525 0
Department of Education and Early Childhood Development
GPO Box 4367
MELBOURNE, Victoria 3001
Country [1] 288525 0
Australia
Other collaborator category [1] 278225 0
Other Collaborative groups
Name [1] 278225 0
School Governance Australia
Address [1] 278225 0
PO BOX 319
Flemington 3031
Victoria, Australia
Country [1] 278225 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291568 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 291568 0
Ethics committee country [1] 291568 0
Australia
Date submitted for ethics approval [1] 291568 0
15/09/2014
Approval date [1] 291568 0
07/10/2014
Ethics approval number [1] 291568 0
14-210

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 163 163 0 0
/AnzctrAttachments/366965-AJPH final.pdf
Attachments [2] 223 223 0 0
/AnzctrAttachments/366965-MSSE published IR.pdf
Attachments [3] 224 224 0 0
/AnzctrAttachments/366965-HYPERTENSIONAHA.108.123364v1.pdf
Attachments [4] 225 225 0 0
/AnzctrAttachments/366965-PE and Blood Lipds Telford et al 2013.pdf
Attachments [5] 226 226 0 0
/AnzctrAttachments/366965-Determinants of Obesity 2012.pdf

Contacts
Principal investigator
Name 50918 0
Prof Richard D Telford
Address 50918 0
UC Research Institute for Sport and Exercise
University of Canberra
University Drive
Bruce ACT 2617
Country 50918 0
Australia
Phone 50918 0
+61 2-62068883
Fax 50918 0
Email 50918 0
[email protected]
Contact person for public queries
Name 50919 0
Mandi Semple
Address 50919 0
UC Research Institute for Sport and Exercise
University of Canberra
University Drive
Bruce ACT 2617
Country 50919 0
Australia
Phone 50919 0
+61 2-62068883
Fax 50919 0
Email 50919 0
[email protected]
Contact person for scientific queries
Name 50920 0
Richard D Telford
Address 50920 0
UC Research Institute for Sport and Exercise
University of Canberra
University Drive
Bruce ACT 2617
Country 50920 0
Australia
Phone 50920 0
+61 2-62068883
Fax 50920 0
Email 50920 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
SourceTitleYear of PublicationDOI
EmbaseEffects of a Specialist-Led, School Physical Education Program on Bone Mass, Structure, and Strength in Primary School Children: A 4-Year Cluster Randomized Controlled Trial.2016https://dx.doi.org/10.1002/jbmr.2688
EmbaseOutcomes of a four-year specialist-taught physical education program on physical activity: A cluster randomized controlled trial, the LOOK study.2016https://dx.doi.org/10.1186/s12966-016-0388-4
EmbaseUsing compositional data analysis to explore accumulation of sedentary behavior, physical activity and youth health.2022https://dx.doi.org/10.1016/j.jshs.2021.03.004
N.B. These documents automatically identified may not have been verified by the study sponsor.