Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000926639
Ethics application status
Approved
Date submitted
19/08/2014
Date registered
28/08/2014
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a SunSmart policy intervention: a cluster randomized controlled trial of a primary school-based health promotion program
Scientific title
Evaluation of a SunSmart policy intervention with primary school students and teachers in New South Wales to improve the quality of sun protection behaviours adopted by children during recess and lunch periods of the school day and the role modelling of sun protection behaviour by teachers.
Secondary ID [1] 285187 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin cancer 292788 0
Condition category
Condition code
Public Health 293088 293088 0 0
Health promotion/education
Cancer 293140 293140 0 0
Malignant melanoma
Cancer 293141 293141 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
5 x Primary Schools – Community, school and student derived sun protection policy (Intervention group) (Intervention Period - 20 school weeks)

Each of the intervention groups (parents, teachers and students) will work with researchers to devise policy changes to improve sun protection behaviours that are adopted by children during periods when students are exposed to ultraviolet light.
The behaviours sought to be modified include;
a) Students wearing of wide brim hats and sunscreen during UV exposed periods of the day
b) Students playing in shaded areas during periods of high UV exposure
c) Teachers role-modelling the wearing of hats and sunglasses during exposed periods of the day

The policy will be implemented by working with teachers (the primary change agent in schools) through professional learning workshops whereby they are given and develop their own strategies in how to model and encourage sun safe practices in primary school-aged children. These workshops will be guided by focus groups conducted with grade 6 students, parents and other teachers in the school community as to what are the enablers and barrieris to effective promotion of sun safe behaviours. The policies will also be required to adhere to the three pillars of the Health-Promoting Schools Framework.

Objective direct observation data collection will be used to monitor adhearence of teacher role-modelling behaviour. Post follow-up focus groups may also be conducted with teachers and students (time and funding pending) to ascertain the perceived adherence to the intervention.
Intervention code [1] 290053 0
Lifestyle
Intervention code [2] 290054 0
Prevention
Intervention code [3] 290055 0
Behaviour
Comparator / control treatment
15 x Primary Schools - Existing school sun protection policy
(Control/Comparison group)
Control group
Active

Outcomes
Primary outcome [1] 292949 0
Primary outcome 1: Primary students wearing hats will be assessed via direct observation (SOPLAY Instrument) of shaded and exposed playground areas during recess, lunch, school sport and during physical education classes
Timepoint [1] 292949 0
Timepoint: At baseline (3 months of observations during Term 4 - 2014) prior to randomisation, at one year (During Term 4 -2015) after randomisation and intervention and again in three months (During Term 1 - 2016) as a follow-up after the Summer School Holidays
Primary outcome [2] 292950 0
Primary outcome 2: Grade 6 students wearing of sunscreen will be assessed by measuring the consumption of sunscreen provided to these classes.
Timepoint [2] 292950 0
Timepoint: At baseline (3 months of observations during Term 4 - 2014) prior to randomisation, at one year (During Term 4 -2015) after randomisation and intervention and again in three months (During Term 1 - 2016) as a follow-up after the Summer School Holidays
Primary outcome [3] 292951 0
Primary outcome 3: Teacher wearing of hats and sunglasses will be assessed via direct observation (SOPLAY Instrument) of shaded and exposed playground areas during recess, lunch, school sport and during physical education classes
Timepoint [3] 292951 0
Timepoint: At baseline (3 months of observations during Term 4 - 2014) prior to randomisation, at one year (During Term 4 -2015) after randomisation and intervention and again in three months (During Term 1 - 2016) as a follow-up after the Summer School Holidays
Secondary outcome [1] 309999 0
Nil
Timepoint [1] 309999 0
Nil

Eligibility
Key inclusion criteria
1. Primary school students and teachers in existing NSW government schools with a sun protection policy.
2. Schools must fall within the Greater Western Sydney catchment area
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-government schools

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Simple randomisation using a bias-coin algorithm to ensure that only 5 schools are allocated to the intervention and 15 to the control group by a researcher not involved in the study and who is “off-site” from other researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a bias-coin algorithm to ensure that only 5 schools are allocated to the intervention and 15 to the control group by a researcher not involved in the study and who is “off-site” from other researchers.
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
Intervention Group recieves policy and intervention support.

Control group continues with exisiting sun protection policy.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations were conducted to determine the sample size required to detect changes in the in the primary outcome of direct observations per observation period [Ref SOPLAY]. Calculations assumed baseline-posttest were based on 80% power, with alpha levels set at p < 0.05. Using the standard deviation (SD) of change from a previous SOPLAY study (SD =121.1), it was calculated that 5 observations per school, with 20 clusters (i.e., schools) would provide adequate power to detect a between group difference of d=.4 across the school day.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2014
Actual
1/09/2014
Date of last participant enrolment
Anticipated
19/09/2014
Actual
10/09/2014
Date of last data collection
Anticipated
Actual
20/12/2016
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289800 0
Charities/Societies/Foundations
Name [1] 289800 0
Cancer Council of NSW
Country [1] 289800 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
School of Education, Faculty of Human Sciences, Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 288490 0
University
Name [1] 288490 0
Charles Sturt University
Address [1] 288490 0
School of Teacher Education, Faculty of Education, Panorama Ave Bathurst NSW 2795
Country [1] 288490 0
Australia
Other collaborator category [1] 278100 0
University
Name [1] 278100 0
University of Sydney
Address [1] 278100 0
Faculty of Education and Social Work, Education Building A35 University of Sydney NSW 2006
Country [1] 278100 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291534 0
Charles Sturt University Human Research Ethics Committee
Ethics committee address [1] 291534 0
Ethics committee country [1] 291534 0
Australia
Date submitted for ethics approval [1] 291534 0
Approval date [1] 291534 0
13/06/2014
Ethics approval number [1] 291534 0
2014/062
Ethics committee name [2] 291535 0
State Education Research Approvals Process (SERAP)
Ethics committee address [2] 291535 0
Ethics committee country [2] 291535 0
Australia
Date submitted for ethics approval [2] 291535 0
Approval date [2] 291535 0
03/07/2014
Ethics approval number [2] 291535 0
2014148

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

Contacts
Principal investigator
Name 50774 0
Dr Dean Dudley
Address 50774 0
School of Education, Faculty of Human Sciences, Macquarie University NSW 2109
Country 50774 0
Australia
Phone 50774 0
+61 2 98504864
Fax 50774 0
Email 50774 0
[email protected]
Contact person for public queries
Name 50775 0
Kirsten Jackson
Address 50775 0
Skin Cancer Prevention Unit, Cancer Council NSW, 153 Dowling Street, Woolloomooloo NSW 2011
Country 50775 0
Australia
Phone 50775 0
+61 2 9334 1731
Fax 50775 0
Email 50775 0
[email protected]
Contact person for scientific queries
Name 50776 0
Dean Dudley
Address 50776 0
School of Education, Faculty of Human Sciences, Macquarie University NSW 2109
Country 50776 0
Australia
Phone 50776 0
+61 2 98504864
Fax 50776 0
Email 50776 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
EmbaseRationale and study protocol to evaluate the SunSmart policy intervention: a cluster randomised controlled trial of a primary school-based health promotion program.2015https://dx.doi.org/10.1186/s12889-015-1371-8
N.B. These documents automatically identified may not have been verified by the study sponsor.