ANZCTR - Registration

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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

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]

None

Universal Trial Number (UTN)

Trial acronym

AWARE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Physical activity

Condition category

Condition code

Public Health

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]

Prevention

Intervention code [2]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Baseline, 9 months post baseline (primary end point) and 18 months post baseline for a subset of schools recruited in 2021.

Secondary outcome [6]

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]

Baseline, 9 months post baseline (primary end point) and 18 months post baseline for a subset of schools recruited in 2021.

Secondary outcome [7]

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]

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]

Government body

Name [1]

NSW Ministry of Health

Address [1]

100 Christie Street
St Leonards, NSW 2065

Country [1]

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]

University

Name [1]

University of Newcastle

Address [1]

University Drive
Callaghan NSW 2308

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Research Ethics Committee

Ethics committee address [1]

Lot 1, Kookaburra Circuit
New Lambton Heights NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/09/2020

Approval date [1]

10/11/2020

Ethics approval number [1]

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

A/Prof Luke Wolfenden

Address

Hunter New England Population Health
Booth Building
Longworth Avenue
Wallsend, NSW 2287

Country

Australia

Phone

+61 0249246567

Fax

luke.wolfenden@health.nsw.gov.au

Contact person for public queries

Name

Nicole McCarthy

Address

Hunter New England Population Health
Booth Building
Longworth Avenue
Wallsend, NSW 2287

Country

Australia

Phone

+61 0249426669

Fax

nicole.mccarthy@health.nsw.gov.au

Contact person for scientific queries

Name

Nicole McCarthy

Address

Hunter New England Population Health
Booth Building
Longworth Avenue
Wallsend, NSW 2287

Country

Australia

Phone

+61 0249426669

Fax

nicole.mccarthy@health.nsw.gov.au

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
luke.wolfenden@health.nsw.gov.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9588	Study protocol			Nicole.McCarthy@health.nsw.gov.au	NA
9589	Ethical approval	NA		Nicole.McCarthy@health.nsw.gov.au	NA

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Cluster 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.	2022	https://dx.doi.org/10.1136/bmjopen-2022-064692

N.B. These documents automatically identified may not have been verified by the study sponsor.

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