Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001266358
Ethics application status
Approved
Date submitted
24/08/2017
Date registered
1/09/2017
Date last updated
14/08/2019
Date data sharing statement initially provided
14/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Active Wear for Everyone (AWE): The effect of wearing the school sports uniform on children’s physical activity
Scientific title
A randomised controlled trial to measure the effect of school sports uniform attire on physical activity of primary school children
Secondary ID [1] 292714 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AWE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Activity 304480 0
Condition category
Condition code
Public Health 303816 303816 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sixty NSW primary schools will be randomised to either a one day intervention or control. Students in grades 2 and 3 attending the intervention schools will wear their sports uniform for one day (when they would normally wear a traditional uniform) and which is not their scheduled sports day. The one day that the students wear their sports uniform will be randomly allocated. Teachers will be asked to note which students forget to wear uniform on the particular day. Nothing else will be required of schools or students. Students in control schools will continue with normal uniform practices for the school week.
Intervention code [1] 298960 0
Prevention
Intervention code [2] 298961 0
Lifestyle
Comparator / control treatment
Usual practice (no change to uniform requirements)
Control group
Active

Outcomes
Primary outcome [1] 303177 0
Girl’s physical activity- mean minutes of MVPA per day will be measured objectively using wrist-worn accelerometers, by students in grade 2-3 at all schools for 5 consecutive school days. Data will be analysed for whole school day as well as segmented.
Timepoint [1] 303177 0
Baseline and for the one day during intervention exposure
Primary outcome [2] 303210 0
Girl’s physical activity- mean physical activity counts per minute will be measured objectively using wrist-worn accelerometers, by students in grade 2-3 at all schools for 5 consecutive school days. Data will be analysed for whole school day as well as segmented..
Timepoint [2] 303210 0
Baseline and for the one day during intervention exposure
Secondary outcome [1] 338144 0
All students’ physical activity- mean physical activity counts per minute will be measured objectively using wrist-worn accelerometers, by students in grade 2-3 at all schools for 5 consecutive school days. Data will be analysed for whole school day as well as segmented.
Timepoint [1] 338144 0
Baseline and for the one day during intervention exposure
Secondary outcome [2] 338251 0
All students’ physical activity-mean minutes of MVPA per day will be measured objectively using wrist-worn accelerometers, by students in grade 2-3 at all schools for 5 consecutive school days. Data will be analysed for whole school day as well as segmented.
Timepoint [2] 338251 0
Baseline and for the one day during intervention exposure

Eligibility
Key inclusion criteria
Catholic primary schools within the Hunter New England Local Health District and Mid North Coast Local Health District of NSW will be invited to participate. All grade 2 and 3 students at eligible schools will be invited to participate.
Minimum age
6 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools will be ineligible if they; cater exclusively for children requiring specialist care; are already involved in a physical activity trial; and/or currently only have a sports uniform that children wear each day. All students in grades 2 and 3 are eligible to participate in the trial

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)
Schools will be randomised in a 1:1 ratio to either an intervention or control group via a central randomisation process by computer Block randomisation will be employed to ensure group allocation is approximately equal. Data collectors will be blind to group allocation. Due to the nature of the intervention school staff will be aware of their group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician will use a computerised random number function to randomise schools in a 1:1 ratio
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/10/2017
Actual
23/10/2017
Date of last participant enrolment
Anticipated
20/12/2017
Actual
10/12/2017
Date of last data collection
Anticipated
Actual
15/12/2017
Sample size
Target
900
Accrual to date
Final
1500
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297357 0
Government body
Name [1] 297357 0
Hunter New England Population Health
Country [1] 297357 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Locked Bag 10
Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 296333 0
None
Name [1] 296333 0
Address [1] 296333 0
Country [1] 296333 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298455 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 298455 0
Ethics committee country [1] 298455 0
Australia
Date submitted for ethics approval [1] 298455 0
Approval date [1] 298455 0
08/08/2017
Ethics approval number [1] 298455 0
06/07/26/4.04
Ethics committee name [2] 298456 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 298456 0
Ethics committee country [2] 298456 0
Australia
Date submitted for ethics approval [2] 298456 0
Approval date [2] 298456 0
21/07/2017
Ethics approval number [2] 298456 0
H-2008-0343
Ethics committee name [3] 298457 0
Catholic Schools Office – Maitland Newcastle Diocese
Ethics committee address [3] 298457 0
Ethics committee country [3] 298457 0
Australia
Date submitted for ethics approval [3] 298457 0
26/07/2017
Approval date [3] 298457 0
10/08/2017
Ethics approval number [3] 298457 0
2012277

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

Contacts
Principal investigator
Name 77142 0
Dr Nicole Nathan
Address 77142 0
Hunter New England Population Health
Longworth Avenue
WALLSEND, NSW 2287
Country 77142 0
Australia
Phone 77142 0
+ 61 2 49246482
Fax 77142 0
+ 61 2 49246490
Email 77142 0
[email protected]
Contact person for public queries
Name 77143 0
Nicole McCarthy
Address 77143 0
Hunter New England Population Health
Longworth Avenue
WALLSEND, NSW 2287
Country 77143 0
Australia
Phone 77143 0
+ 61 2 49246482
Fax 77143 0
+ 61 2 49246209
Email 77143 0
[email protected]
Contact person for scientific queries
Name 77144 0
Nicole Nathan
Address 77144 0
Hunter New England Population Health
Longworth Avenue
WALLSEND, NSW 2287
Country 77144 0
Australia
Phone 77144 0
+ 61 2 49246257
Fax 77144 0
+ 61 2 49246209
Email 77144 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4019Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe impact of school uniforms on primary school student's physical activity at school: outcomes of a cluster randomized controlled trial.2021https://dx.doi.org/10.1186/s12966-021-01084-0
N.B. These documents automatically identified may not have been verified by the study sponsor.