Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000201875
Ethics application status
Approved
Date submitted
24/11/2020
Date registered
26/02/2021
Date last updated
6/09/2022
Date data sharing statement initially provided
26/02/2021
Date results information initially provided
25/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Active WeAR Everyday (AWARE): The effect of wearing a sports uniform everyday on student fitness and physical activity at school.
Scientific title
A cluster randomised controlled trial to assess the effect of wearing a school sports uniform everyday on primary school students cardiorespiratory fitness and physical activity.
Secondary ID [1] 302684 0
None
Universal Trial Number (UTN)
Trial acronym
AWARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity 319476 0
Condition category
Condition code
Public Health 317440 317440 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves students in grades 4, 5 and 6 swapping their traditional school uniform for an active supportive uniform for approximately a 9 month period for all schools (up to 18 months for a sub group of schools recruited in 2021). Schools randomised to receive the intervention will introduce an ‘activity supporting’ school uniform. This may include the introduction of uniform options (e.g. shorts, polo shirt and sports shoes), or allowing children to wear their existing school sport uniform each day of the week. Parent and student surveys will assess what school uniform (i.e. active uniform or traditional uniform) students have been wearing to school, every day excluding sports days. In addition teacher surveys will assess the proportion of students in their class who have been wearing an active uniform vs. the traditional uniform on non-sports days. These survey items will be used to monitor intervention adherence.
Intervention code [1] 318876 0
Prevention
Intervention code [2] 318983 0
Lifestyle
Comparator / control treatment
Usual practice. Schools randomised to the control group will make no changes to their current uniform policy.
Control group
Active

Outcomes
Primary outcome [1] 325479 0
Cardiorespiratory fitness - will be measured in students from grades 4, 5 or 6 from all schools via the multistage fitness test, which is also known as the 20m shuttle run.
Timepoint [1] 325479 0
Baseline, 9 months post baseline (primary endpoint) and 18 months post baseline for a sub sample of schools that were recruited in 2021
Secondary outcome [1] 388074 0
Children's overall quality of life will be measured as a composite outcome in all students in grade 4, 5 and 6 using the Child Health Utility 9D questionnaire and the 27-item parent proxy KidScreen questionnaire. The WHO-5 well-being index and an adapted version of the Physical Activity Self-efficacy scale (PASE) will also be included.
Timepoint [1] 388074 0
Baseline, 9 months post baseline (primary endpoint) and 18 months post baseline for a sub sample of schools that were recruited in 2021
Secondary outcome [2] 388520 0
Mean step count will be measured objectively using wrist worn accelerometers by students in grade 4, 5 and 6 at all schools for 5 consecutive school days. Data will be analysed for whole day as well as segmented.
Timepoint [2] 388520 0
Baseline, 9 months post baseline (primary endpoint) and 18 months post baseline for a sub sample of schools that were recruited in 2021
Secondary outcome [3] 413367 0
Acceptability
Principals, teachers, parents and students will be asked via their respective surveys (designed by the research team) to report, on a 5-pont Likert scale (1- Strongly Disagree to 5 Strongly Agree), the extent they agree that since children have been wearing their sports uniform everyday the extent they agree that:
• Principals and Teachers- they prefer students wearing this uniform, students are more active, they (the teachers) are more active, it reflects poorly on the school, students are more disruptive.
• Parents- they prefer their child to wear this uniform, it makes their child more active at school, it makes their child more active outside of school, it has made it easier for their child to get ready for school, it reflects poorly on the school image, it has caused financial burden to their family.
• Students- they have enjoyed wearing their sports uniform, are more active at school, are more active after school, have found it easier to get ready for school in the morning, it makes the school look untidy and their teacher delivers more physical activity.
Timepoint [3] 413367 0
Baseline and 9 months post baseline (primary end point) and 18 months post baseline in a sub set of schools that were recruited in 2021.
Secondary outcome [4] 413368 0
Cost effectiveness
Cost effectiveness will be measured via the parent survey (designed by the research team) Parents will be asked to report on average how many sports and traditional uniforms they currently have for their child as well as how much they spend on school shoes and sports shoes per year. At follow-up, parents of children in both groups will be asked to report if they had to purchase any new uniforms or shoes for their child in the last 12 months.
Timepoint [4] 413368 0
Baseline, 9 months post baseline (primary end point) and 18 months post baseline in a sub set of schools recruited in 2021
Secondary outcome [5] 413369 0
Steps per minute
Steps per minute will be measured objectively using wrist worn accelerometers by students in grade 4, 5 and 6 at all schools for 5 consecutive school days. Data will be analysed for whole day as well as segmented.
Timepoint [5] 413369 0
Baseline, 9 months post baseline (primary end point) and 18 months post baseline for a subset of schools recruited in 2021.
Secondary outcome [6] 413677 0
School, student and parent characteristics- Data regarding school type (Government, Catholic, Independent) number of students, and the postcode of the locality of the school will be collected during a survey of school principals and classroom teachers (using measures developed specifically for this study), or collected from publicly available records (e.g. NSW Department of Education Website). Students’ sex, age and residential postcode will be collected from student consent forms. Parents will be asked to include their sex, date of birth and postcode (used to determine children’s sociodemographic and geographic location).
Timepoint [6] 413677 0
Baseline, 9 months post baseline (primary end point) and 18 months post baseline for a subset of schools recruited in 2021.
Secondary outcome [7] 413678 0
Adherence to uniform changes- Parents and students will be asked at follow-up, via their respective paper or online survey, to report what uniform students wore each day over the last week. These measures are designed specifically for this study.
Timepoint [7] 413678 0
9 months post baseline (primary end point) and 18 months post baseline for a subset of schools recruited in 2021

Eligibility
Key inclusion criteria
All government, catholic and independent primary schools who have a formal uniform policy, located in New South Wales, not participating in another physical activity intervention, and do not cater exclusively for only children who require specialist care, will be eligible to participate. Eligible schools will be identified by school uniform policies made available on the schools website and project officer records.
Parents, teachers and students from grades 4 and 5 in participating schools will be eligible.
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Randomisation will be undertaken by a central randomisation process conducted by an independent statistician, not involved in determining the eligibility of schools or in the recruitment of schools, using a computerised random number generator, following baseline data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation procedure (1:1) stratified by school sector (i.e. government, catholic, independent) will be used to randomise 24 schools to either:
a) Intervention group: who will introduce an activity supporting school uniform, (12
schools); or
b) Control group: who will maintain their current traditional school uniform, (12 schools)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Between group differences in trial outcomes at 9 and 18 month follow-up will be assessed using linear mixed models for continuous outcomes and generalized linear mixed models for dichotomous or categorical outcomes. The primary end-point will be 9 months follow-up. All models will include a random intercept for school to account for the clustered design of the trial, and fixed effects for group and the baseline value of the outcome. The primary analyses will be conducted under an intention-to-treat framework, with all available data analyzed. Multiple imputation will be used to address missing data. Per protocol analyses will also be conducted to explore differences between students who wore an active uniform to those who did not. An alpha level of 5% will be used to determine statistically significant differences. Planned exploratory analyses will examine effects by subgroups (e.g. gender and high and low activity levels), which will be assessed by including a sub group by experimental group interaction term in the models.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/03/2021
Actual
19/04/2021
Date of last participant enrolment
Anticipated
3/06/2022
Actual
3/06/2022
Date of last data collection
Anticipated
9/12/2022
Actual
Sample size
Target
1200
Accrual to date
Final
567
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307021 0
Government body
Name [1] 307021 0
NSW Ministry of Health
Country [1] 307021 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] 307591 0
University
Name [1] 307591 0
University of Newcastle
Address [1] 307591 0
University Drive
Callaghan NSW 2308
Country [1] 307591 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307152 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 307152 0
Lot 1, Kookaburra Circuit
New Lambton Heights NSW 2305
Ethics committee country [1] 307152 0
Australia
Date submitted for ethics approval [1] 307152 0
30/09/2020
Approval date [1] 307152 0
10/11/2020
Ethics approval number [1] 307152 0

Summary
Brief summary
The overall objective of this study is to assess the effectiveness of a simple, scalable intervention (an ‘activity supporting’ school uniform) in reducing cardiovascular risks in children attending primary school. The primary aim is to compare the difference between the intervention and control group in their mean cardio-respiratory fitness at 9 months (primary end-point) and 18 months follow up, as measured by a multistage fitness test. It is hypothesised that the intervention group will report a higher mean cardiovascular fitness compared to the control group.
Trial website
Trial related presentations / publications
Public notes
Due to disruptions caused by COVID-19 and school lockdowns recruitment and baseline data collection occurred in two waves. The first wave occurred in 2021 and includes the original baseline sample of students from grades 4 and 5 with both follow-up data collection points at 9 and 18-months. The second wave of school recruitment began in 2022 and to align with the first wave will include students in grades 5 and 6 and will only include follow-up at the primary end-point of 9-months. This is to ensure that the study complies with the necessary timelines.

Contacts
Principal investigator
Name 106214 0
A/Prof Luke Wolfenden
Address 106214 0
Hunter New England Population Health
Booth Building
Longworth Avenue
Wallsend, NSW 2287
Country 106214 0
Australia
Phone 106214 0
+61 0249246567
Fax 106214 0
Email 106214 0
[email protected]
Contact person for public queries
Name 106215 0
Mrs Nicole McCarthy
Address 106215 0
Hunter New England Population Health
Booth Building
Longworth Avenue
Wallsend, NSW 2287
Country 106215 0
Australia
Phone 106215 0
+61 0249426669
Fax 106215 0
Email 106215 0
[email protected]
Contact person for scientific queries
Name 106216 0
Mrs Nicole McCarthy
Address 106216 0
Hunter New England Population Health
Booth Building
Longworth Avenue
Wallsend, NSW 2287
Country 106216 0
Australia
Phone 106216 0
+61 0249426669
Fax 106216 0
Email 106216 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All De-identified individual participant data collected during the trial will be made available on reasonable request.
When will data be available (start and end dates)?
Data will be available from 12-months following publication of the trial results, with no specified end date but maintaining accordance with terms and conditions of data retention.
Available to whom?
De-identified data and data dictionaries will be made available on reasonable request, approved by the Principal Investigator.
Available for what types of analyses?
Approved on request by Principal Investigator.
How or where can data be obtained?
By request to the Principal Investigator, Luke Wolfenden
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9588Study protocol  [email protected] NA
9589Ethical approvalNA [email protected] NA



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCluster randomised controlled trial to determine the impact of an activity enabling uniform on primary school student's fitness and physical activity: study protocol for the Active WeAR Everyday (AWARE) study.2022https://dx.doi.org/10.1136/bmjopen-2022-064692
N.B. These documents automatically identified may not have been verified by the study sponsor.