Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001128684
Ethics application status
Approved
Date submitted
15/09/2014
Date registered
23/10/2014
Date last updated
23/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
PACE: A school playground environmental and policy intervention to promote break time physical activity in primary-school-aged children.
Scientific title
In children aged 4-13years, does introducing school break time environmental and policy changes promote break time physical activity?
Secondary ID [1] 285331 0
Nil
Universal Trial Number (UTN)
U1111-1161-7022
Trial acronym
PACE: Physical Activity Children and the Environment
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 293056 0
Bullying 293057 0
Condition category
Condition code
Public Health 293328 293328 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three-month, 2-arm, pilot group randomised controlled trial. Children aged 4 to 13 years who attend four selected small primary schools (student population approx 300 students) will be recruited for this study. Tacit consent will be gained at all four schools for playground observational physical activity data for all children aged 4 to 13 years. In addition, children in Years 4, 5 and 6 will be given the opportunity to complete a Peer Relations Survey. Primary outcome data (accelerometry) will be collected on 50-60 randomly selected children in Years 4, 5 and 6 at each school. Written consent will be gained for children completing the Peer Relations Survey and for those who are to be fitted with accelerometers. Consent forms will be distributed through participating schools.
Following baseline measurements, schools will be randomised to either the intervention or a wait-list control group. The intervention schools will implement PACE (described below) following base line data collection in Term 2 of the school calendar. The intervention will run for 3 months. For ethical reasons and to minimize bias resulting from compensatory rivalry and resentful demoralization (Murray, 1998), we will offer the PACE intervention to the control schools at the completion of post-intervention assessment.
PACE is a multi-component intervention designed to modify the physical (introduction of non-fixed equipment such as balls, skipping ropes and hoops) and policy-related (e.g. length of break time, no hat no play, time available for play, access to large playground areas) school playground environments to promote break time physical activity. We will also assess the impact of psychosocial variables (bullying) on children’s playground physical activity levels. PACE is guided by Social Cognitive Theory, in particular the environmental determinants of behaviour which includes reciprocal determinism and facilitation (Glanz, Rimer, & Viswanath, 2008). Following discussion with school principals, school staff, students and parents will be informed about the PACE intervention at a staff meeting, school assembly and Parents & Friends (P&F) meeting respectively. Research staff, the Principal, two students and two staff members from each intervention school will be invited to be part of a committee to implement PACE. To be part of the intervention, schools must agree to allow children access to non-fixed equipment for each break period. Each classroom will be allocated a quota of equipment for use during the break which will be monitored by a student from each class and signed for by users. The following policy changes will be included in the intervention: a maximum 5 minutes sitting at recess and 10 minutes at lunch, minimum 5 minutes extension of each break period, introduction of a ‘no hat, play in the shade’ policy (as an alternative to ‘no hat, no play’), and a revision of policies to encourage maximum access to sporting fields.
Intervention code [1] 290252 0
Prevention
Intervention code [2] 290253 0
Lifestyle
Intervention code [3] 290254 0
Behaviour
Comparator / control treatment
Schools randomised to the control group will continue with their usual activities. The intervention strategies will be offered to these schools at the end of the 3 month intervention period in Term 4.
Control group
Active

Outcomes
Primary outcome [1] 293166 0
Potential efficacy/behaviour change: In school playground physical activity levels will be assessed using the SOPLAY observational tool.
Timepoint [1] 293166 0
Data will be collected at baseline and after 3 month follow-up
Primary outcome [2] 293167 0
Potential feasibility of the intervention assessed using a teacher survey. Feasibility will be assessed by recording the number of children recruited to the study, and the amount of useable data collected at each school (a priori aim is to collect data on 90% of consenting students at both baseline and follow-up).
Timepoint [2] 293167 0
Assessed during the intervention period from baseline to followup (3 month time period)
Primary outcome [3] 293223 0
Potential acceptability of the intervention using a teacher and student survey. Acceptability will be assessed by monitoring intervention fidelity at each school, and staff, student, and P & C evaluations of the success of each component of the intervention and feedback on its implementation.
Timepoint [3] 293223 0
Data will be collected at baseline and after 3 months at followup.
Secondary outcome [1] 310481 0
To determine whether bullying impacts children’s playground physical activity were assessed using accelerometers and bullying was assessed using a survey which was adapted from the validated Peer Victimisation Scale and the Peer Relations Questionnaire (Rigby and Slee 1993, Neary and Joseph 1994).
Timepoint [1] 310481 0
Data will be collected at baseline and after 3 months at followup.

Eligibility
Key inclusion criteria
Schools will be recruited based on similarities in student numbers- efforts will be made to try to match similar sized schools, existing policies and equipment- efforts will be made to recruit schools that do not have the proposed policies and equipment options for break time activity, and also their willingness to be involved in the study (including to be randomised).
Minimum age
4 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools will be excluded if they are not willing to be involved in the intervention component of the study

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)
Four Illawarra Primary schools will be recruited through the Catholic Education Office. Principals will be contacted via email to gauge their interest in the project. Schools will be recruited based on similarities in student numbers, existing policies and equipment, and their willingness to be involved in the study (including to be randomised). A member of the research team will meet with interested schools to discuss the study in more detail. Schools committing to participate will be provided with information sheets and consent forms for children in years 4-6. Following baseline measurements, schools will be randomised to either the intervention or a wait-list control group. Schools will be randomised by having an independent person draw folded pieces of paper with the schools codes on them from a hat. The intervention will run for 5-6 months.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot group randomized controlled trial the primary aims are to examine the potential feasibility, acceptability and potential efficacy of the intervention. These factors need to be examined prior to undertaking an adequately powered and larger scale trial, where intervention efficacy can be appropriately tested. The sample size of four schools, with 50-60 students in each school will be adequate to examine the aims of this pilot study (Riethmuller et al 2010).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
20/06/2011
Date of last participant enrolment
Anticipated
19/12/2011
Actual
28/11/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8700 0
2500 - West Wollongong
Recruitment postcode(s) [2] 8701 0
2526 - Unanderra
Recruitment postcode(s) [3] 8702 0
2530 - Dapto
Recruitment postcode(s) [4] 8703 0
2529 - Shellharbour

Funding & Sponsors
Funding source category [1] 289953 0
University
Name [1] 289953 0
University of Wollongong
Country [1] 289953 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
University of Wollongong
Northfields Avenue
Wollongong NSW
2522
Country
Australia
Secondary sponsor category [1] 288643 0
None
Name [1] 288643 0
Address [1] 288643 0
Country [1] 288643 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291670 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 291670 0
Ethics committee country [1] 291670 0
Australia
Date submitted for ethics approval [1] 291670 0
Approval date [1] 291670 0
18/05/2011
Ethics approval number [1] 291670 0
HE11/124

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

Contacts
Principal investigator
Name 51086 0
Dr Anne-Maree Parrish
Address 51086 0
School of Health and Society
University of Wollongong
Northfields avenue
Wollongong NSW
2522
Country 51086 0
Australia
Phone 51086 0
+61 2 4221 5098
Fax 51086 0
+ 61 2 4221 5945
Email 51086 0
[email protected]
Contact person for public queries
Name 51087 0
Anne-Maree Parrish
Address 51087 0
School of Health and Society
University of Wollongong
Northfields avenue
Wollongong NSW
2522
Country 51087 0
Australia
Phone 51087 0
+61 2 4221 5098
Fax 51087 0
+ 61 2 4221 5945
Email 51087 0
[email protected]
Contact person for scientific queries
Name 51088 0
Anne-Maree Parrish
Address 51088 0
School of Health and Society
University of Wollongong
Northfields avenue
Wollongong NSW
2522
Country 51088 0
Australia
Phone 51088 0
+61 2 4221 5098
Fax 51088 0
+ 61 2 4221 5945
Email 51088 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
EmbasePACE: A group randomised controlled trial to increase children's break-time playground physical activity.2016https://dx.doi.org/10.1016/j.jsams.2015.04.017
N.B. These documents automatically identified may not have been verified by the study sponsor.