Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000437561
Ethics application status
Approved
Date submitted
23/04/2015
Date registered
7/05/2015
Date last updated
18/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial of an intervention to facilitate the implementation of school-based practices known to increase students’ moderate-to-vigorous physical activity.
Scientific title
Are primary-school students attending schools that receive a multi-component intervention to facilitate the implementation of school-based physical activity practices, more likely than students attending schools that receive no intervention, to increase their levels of moderate-to-vigorous physical activity?
Secondary ID [1] 286582 0
Nil known
Universal Trial Number (UTN)
-
Trial acronym
SCORES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity Prevention 294843 0
Condition category
Condition code
Public Health 295112 295112 0 0
Health promotion/education
Diet and Nutrition 295202 295202 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The physical activity practices to be implemented in schools are derived from the “Supporting Children’s Outcomes using Rewards, Exercise and Skills” (SCORES) program. These practices will allow us to evaluate the health service program. Practices include: a) Teacher professional development to deliver quality physical education lessons; b) Development of a school physical activity policy; c) Provision of recess and lunch physical activity sessions; d) Incentives to engage students in physical activity; and e) Parental engagement via newsletters. To facilitate the implementation of these practices, the following strategies will be used:-
1) Executive support: The school principal will be encouraged to demonstrate and communicate support for the SCORES program by: electing a school champion (teacher from the intervention school) to lead the intervention; speaking to teachers about the intervention at staff meetings; supporting teachers to participate in professional development training; and developing a school physical activity policy which outlines the teaching of fundamental movement skills, guidelines for recess and lunch-time physical activity sessions, and methods to engage parents such as providing newsletters.
2) Staff training: All teachers will be invited to attend an onsite, 90 minute professional development workshop facilitated by a qualified Personal Development, Health and Physical Education (PDHPE) teacher. The workshop will aim to build skills in delivering quality physical education lessons, including the teaching of Fundamental Movement Skills (FMS) and adherence to “Supportive, Active, Autonomous, Fair and Enjoyable” (SAAFE) teaching principles.
3) Tools and resources: Resources provided to teachers at the professional development workshop will include: the SCORES Activity Handbook; the SAAFE lesson plan template; the SAAFE checklist for self-assessment; SAAFE posters; a sample of a PDHPE scope and sequence; and a list of minimum equipment for lessons. Resources provided to school champions will include: a checklist of weekly tasks and reminders; idea sheets for recess and lunch-time activity sessions; and SCORES program newsletters for distribution to parents.
4) Academic detailing: A follow-up visit to the school by a support officer will take place one-month after the teachers’ professional development training. The support officer will conduct peer-teaching to assist teachers to use the SAAFE principles when planning their physical activity lessons and problem-solve any barriers to implementing the school’s physical activity policy.
5) Ongoing support: Short, 5 minute duration video clips demonstrating the SAAFE teaching principles will be emailed every 2 weeks to schools throughout the 2nd term of the intervention. Principals will be encouraged to show these videos at staff meetings. Support officers will conduct 1 observation of physical activity lessons in the 2nd term of the intervention and provide feedback to teachers using the SAAFE checklist. School champions will be sent fortnightly emails containing tips for how to continue to implement the SCORES program within the school.
6) Recognition and incentives: School champions will receive a SCORES program polo shirt as soon as all meetings, training sessions, and observation sessions have been scheduled. Teachers who attend the professional development workshop will receive whistles, lanyards, stickers and merit certificates, which can be presented to students who take part in recess and lunch-time activities. Schools will receive equipment packs once all of the SAAFE videos have been viewed at staff meetings.
7) Performance monitoring and feedback: Two reports regarding the school’s progress towards implementing the SCORES program will be provided to the principal and school champion (one report per term). The first report will be sent one week following peer-teaching, and the second report will be sent one week after the physical education lesson observations.
The overall duration is 9 months (3 school terms)
Intervention code [1] 291697 0
Prevention
Intervention code [2] 291698 0
Behaviour
Intervention code [3] 291761 0
Lifestyle
Comparator / control treatment
Usual practice (no intervention) – consisting of usual school practices towards physical activity, which may or may not include professional development opportunities for teachers, physical activity resources, and/or school policies.
Control group
Active

Outcomes
Primary outcome [1] 294879 0
The primary outcome of interest is the level of students’ moderate-to-vigorous physical activity (MVPA). Total minutes of MVPA will be measured objectively using an accelerometer, worn by randomly selected Grade 3 to Grade 6 students from 10 intervention and 10 control schools, for 7 consecutive days. It is expected there will be an 11 minute difference between the mean MVPA of intervention group students and control group students.
Timepoint [1] 294879 0
The timepoint for data collection is 6 months post-intervention.
Secondary outcome [1] 314269 0
The secondary outcome of interest is the implementation of SAAFE principles during the teaching of physical education (PE) classes. Adherence to SAAFE principles will be objectively measured using the SAAFE checklist. A support officer will observe up to four physical education lessons per school, randomly selected across Grade 3 to Grade 6. It is expected that there will be a 10% difference (8 point difference on the SAAFE checklist) between the proportion of teachers that conduct PE lessons according to SAAFE principles at intervention schools, compared to control schools.
Timepoint [1] 314269 0
The timepoint for data collection is 6 months post-intervention.

Eligibility
Key inclusion criteria
A random selection of Government and Catholic primary schools within the Hunter New England Local Health District of NSW will be invited to participate.
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools from the Australian Independent Schools Association; schools catering exclusively for children requiring specialist care; and schools who are already implementing a physical activity intervention trial, will be ineligible to participate.

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)
A list of eligible Government and Catholic primary schools within the Hunter New England Local Health District of NSW will serve as the sample. 64 schools will be randomly selected from the list and allocated to either an intervention or control group in a 1:1 ratio.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation will be performed by an independent Statistician using a computerised random number function.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
-
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 32 intervention and 32 control schools will be recruited. Trial outcomes will be assessed for 10 intervention and 10 control schools by post-intervention comparison of between group differences. Trial outcomes include: 1) differences in the mean minutes of MVPA between intervention group students and control group students; and 2) differences in the mean SAAFE checklist score between teachers in the intervention group and teachers in the control group. If 4 lessons (4 teachers) are observed per school, this will result in data from 40 experimental teachers and 40 control teachers, which will allow detection of a true difference in the mean score between both groups of 15% with a power of 0.8 and a Type 1 error probability of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/10/2014
Actual
7/10/2014
Date of last participant enrolment
Anticipated
3/04/2015
Actual
3/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 9546 0
2350 - Armidale
Recruitment postcode(s) [2] 9547 0
2323 - Ashtonfield
Recruitment postcode(s) [3] 9548 0
2278 - Barnsley
Recruitment postcode(s) [4] 9549 0
2280 - Belmont
Recruitment postcode(s) [5] 9550 0
2404 - Bingara
Recruitment postcode(s) [6] 9551 0
2322 - Black Hill
Recruitment postcode(s) [7] 9552 0
2338 - Blandford
Recruitment postcode(s) [8] 9553 0
2405 - Boomi
Recruitment postcode(s) [9] 9554 0
2359 - Bundarra
Recruitment postcode(s) [10] 9555 0
2290 - Charlestown
Recruitment postcode(s) [11] 9556 0
2325 - Congewai
Recruitment postcode(s) [12] 9557 0
2427 - Crowdy Head
Recruitment postcode(s) [13] 9558 0
2328 - Denman
Recruitment postcode(s) [14] 9559 0
2290 - Gateshead
Recruitment postcode(s) [15] 9560 0
2264 - Dora Creek
Recruitment postcode(s) [16] 9561 0
2420 - Dungog
Recruitment postcode(s) [17] 9562 0
2337 - Ellerston
Recruitment postcode(s) [18] 9563 0
2283 - Fennell Bay
Recruitment postcode(s) [19] 9564 0
2370 - Glen Innes
Recruitment postcode(s) [20] 9565 0
2422 - Gloucester
Recruitment postcode(s) [21] 9566 0
2360 - Gilgai
Recruitment postcode(s) [22] 9567 0
2427 - Harrington
Recruitment postcode(s) [23] 9568 0
2360 - Inverell
Recruitment postcode(s) [24] 9569 0
2354 - Kentucky
Recruitment postcode(s) [25] 9570 0
2358 - Kingstown
Recruitment postcode(s) [26] 9571 0
2327 - Kurri Kurri
Recruitment postcode(s) [27] 9572 0
2320 - Maitland
Recruitment postcode(s) [28] 9573 0
2291 - Merewether Heights
Recruitment postcode(s) [29] 9574 0
2329 - Merriwa
Recruitment postcode(s) [30] 9575 0
2324 - Millers Forest
Recruitment postcode(s) [31] 9576 0
4380 - Mingoola
Recruitment postcode(s) [32] 9577 0
2400 - Moree
Recruitment postcode(s) [33] 9578 0
2264 - Morisset
Recruitment postcode(s) [34] 9579 0
2519 - Mount Pleasant
Recruitment postcode(s) [35] 9580 0
2281 - Nords Wharf
Recruitment postcode(s) [36] 9581 0
2388 - Pilliga
Recruitment postcode(s) [37] 9582 0
2336 - Rouchel
Recruitment postcode(s) [38] 9583 0
2343 - Spring Ridge
Recruitment postcode(s) [39] 9584 0
2422 - Stratford
Recruitment postcode(s) [40] 9585 0
2381 - Tambar Springs
Recruitment postcode(s) [41] 9586 0
2340 - Tamworth
Recruitment postcode(s) [42] 9587 0
2430 - Taree
Recruitment postcode(s) [43] 9588 0
2291 - The Junction
Recruitment postcode(s) [44] 9589 0
2400 - Tulloona
Recruitment postcode(s) [45] 9590 0
2430 - Upper Lansdowne
Recruitment postcode(s) [46] 9591 0
2358 - Uralla
Recruitment postcode(s) [47] 9592 0
2382 - Boggabri
Recruitment postcode(s) [48] 9593 0
2354 - Walcha
Recruitment postcode(s) [49] 9594 0
2388 - Wee Waa
Recruitment postcode(s) [50] 9595 0
2286 - West Wallsend
Recruitment postcode(s) [51] 9596 0
2306 - Windale
Recruitment postcode(s) [52] 9597 0
2322 - Woodberry
Recruitment postcode(s) [53] 9598 0
2354 - Woolbrook
Recruitment postcode(s) [54] 9599 0
2354 - Yarrowitch
Recruitment postcode(s) [55] 9600 0
2410 - Yetman

Funding & Sponsors
Funding source category [1] 291142 0
Self funded/Unfunded
Name [1] 291142 0
Country [1] 291142 0
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Locked Bag 10
Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 289824 0
None
Name [1] 289824 0
Address [1] 289824 0
Country [1] 289824 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292719 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 292719 0
Ethics committee country [1] 292719 0
Australia
Date submitted for ethics approval [1] 292719 0
Approval date [1] 292719 0
27/09/2006
Ethics approval number [1] 292719 0
06/07/26/4.04
Ethics committee name [2] 292720 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 292720 0
Ethics committee country [2] 292720 0
Australia
Date submitted for ethics approval [2] 292720 0
Approval date [2] 292720 0
27/01/2009
Ethics approval number [2] 292720 0
H-2008-0343
Ethics committee name [3] 292721 0
NSW Department of Education and Communities – State Education Research Approval Process (SERAP)
Ethics committee address [3] 292721 0
Ethics committee country [3] 292721 0
Australia
Date submitted for ethics approval [3] 292721 0
Approval date [3] 292721 0
11/06/2014
Ethics approval number [3] 292721 0
2012277
Ethics committee name [4] 292722 0
Catholic Education Office
Ethics committee address [4] 292722 0
Ethics committee country [4] 292722 0
Australia
Date submitted for ethics approval [4] 292722 0
Approval date [4] 292722 0
24/09/2010
Ethics approval number [4] 292722 0
722

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

Contacts
Principal investigator
Name 56738 0
A/Prof Luke Wolfenden
Address 56738 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Australia
Country 56738 0
Australia
Phone 56738 0
+ 61 2 4924 6567
Fax 56738 0
+ 61 2 4924 6215
Email 56738 0
[email protected]
Contact person for public queries
Name 56739 0
Rachel Sutherland
Address 56739 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 56739 0
Australia
Phone 56739 0
+ 61 2 4924 6133
Fax 56739 0
+ 61 2 4924 6490
Email 56739 0
[email protected]
Contact person for scientific queries
Name 56740 0
Luke Wolfenden
Address 56740 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 56740 0
Australia
Phone 56740 0
+ 61 2 4924 6567
Fax 56740 0
+ 61 2 4924 6215
Email 56740 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
EmbaseAn RCT to Facilitate Implementation of School Practices Known to Increase Physical Activity.2017https://dx.doi.org/10.1016/j.amepre.2017.08.009
N.B. These documents automatically identified may not have been verified by the study sponsor.