Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000976189
Ethics application status
Approved
Date submitted
19/06/2019
Date registered
9/07/2019
Date last updated
17/11/2020
Date data sharing statement initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Do UV wrist-bands assist in sun protection?
Scientific title
Do UV wrist-bands assist in sun protection in healthy teenagers?
Secondary ID [1] 298541 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sunburn 313360 0
sun exposure 313361 0
skin cancer 313518 0
Condition category
Condition code
Cancer 311801 311801 0 0
Malignant melanoma
Cancer 311802 311802 0 0
Non melanoma skin cancer
Skin 311803 311803 0 0
Other skin conditions
Injuries and Accidents 311804 311804 0 0
Burns
Public Health 311952 311952 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this current research project is to test UV indicating bands to ascertain if these bands can facilitate sun protection behaviour. UV bands will change colour from white (inside) to purple (outside) when in the sun indicating sun protection is required. To assess this product we are conducting a cross-sectional study at the Schoolies Event of the Gold Coast. Schoolies or Schoolies week refers to the Australian tradition of year 12 high-school graduates having week-long holidays at the beach following the end of their final exams. The Schoolies event on the Gold Coast being held from November 16th – November 23rd 2019 is coordinated by the Safer Schoolies Initiative through the Department of Child Safety, Youth and Women. QUT researchers will work with the Safer Schoolies Initiative and have developed a UV wristband (silicon slider, approximately size of 10 cent coin), which will be incorporated into the design of the 2019 Schoolies event entry wrist-band. The silicon slider to attached to the wristband worn on the wrist.

QUT researchers will have a pop-up tent at the registration event and will ask interested Schoolie attendees to consent and participant in the study.

Intervention group: At the Schoolies registration event participants aged 15-18 will be recruited into the study. Approximately 20,000 School leavers attend this event each year. Participants are provided with a free tube of sunscreen (Cancer Council, SPF 50+) and will be instructed to use it in-line with the products labeling instructions. All Schoolies receive the UV indicating band regardless of whether they participate in this study. The UV band is also used to gain entry into Schoolies only events and participants must wear the UV band to gain entry. After consent, the participants recruited will also complete a brief baseline Questionnaire (3 minutes). Participants are asked to use the UV band “as they see fit” during the one-week schoolies event. There are no analytics from the wrist band, the wristband is designed that it cannot be removed once worn. No participant diaries. After using the UV band participants will be emailed an evaluation survey assessing satisfaction with the intervention device and self-reported sun protection habits, sunburn and sunscreen use.
Intervention code [1] 314792 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320474 0
sun exposure practices (using the Sun Protection Habits index by Glanz et al)
Timepoint [1] 320474 0
Online evaluation survey (single assessment conducted 7-days post completion of intervention)
Secondary outcome [1] 371743 0
satisfaction with use of UV band (Using questionnaire designed specifically for this study)
Timepoint [1] 371743 0
Online evaluation survey (single assessment conducted 7-days post completion of intervention)
Secondary outcome [2] 371744 0
sunburn incidence (yes/no);
Timepoint [2] 371744 0
Online evaluation survey (single assessment conducted 7-days post completion of intervention)
Secondary outcome [3] 372333 0
Sunscreen use (yes/no; frequency of use)
Timepoint [3] 372333 0
Online evaluation survey designed for this study (single assessment conducted 7-days post completion of intervention)

Eligibility
Key inclusion criteria
Registered to attend Year 12 Schoolies at the Gold Coast, 2019; 15-18 years of age;
Minimum age
15 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous history of skin cancer; sunscreen allergy

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/11/2019
Actual
16/11/2019
Date of last participant enrolment
Anticipated
16/11/2019
Actual
16/11/2019
Date of last data collection
Anticipated
7/12/2019
Actual
7/12/2019
Sample size
Target
150
Accrual to date
Final
663
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 26809 0
4217 - Gold Coast

Funding & Sponsors
Funding source category [1] 303087 0
University
Name [1] 303087 0
Queensland University of Technology
Country [1] 303087 0
Australia
Funding source category [2] 303088 0
Government body
Name [2] 303088 0
Department of Health, Queensland Health, Safer Schoolies Initiative
Country [2] 303088 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
60 Musk Avenue, Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 303070 0
None
Name [1] 303070 0
Address [1] 303070 0
Country [1] 303070 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303632 0
Queensland University of Technology University Human Research Ethics Committee [EC00171]
Ethics committee address [1] 303632 0
Ethics committee country [1] 303632 0
Australia
Date submitted for ethics approval [1] 303632 0
10/06/2019
Approval date [1] 303632 0
14/06/2019
Ethics approval number [1] 303632 0
1900000435

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

Contacts
Principal investigator
Name 94334 0
Dr Elke Hacker
Address 94334 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 94334 0
Australia
Phone 94334 0
+61 7 3138 9674
Fax 94334 0
Email 94334 0
[email protected]
Contact person for public queries
Name 94335 0
Elke Hacker
Address 94335 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 94335 0
Australia
Phone 94335 0
+61 7 3138 9674
Fax 94335 0
Email 94335 0
[email protected]
Contact person for scientific queries
Name 94336 0
Elke Hacker
Address 94336 0
Queensland University of Technology, Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove, QLD, 4059
Country 94336 0
Australia
Phone 94336 0
+61 7 3138 9674
Fax 94336 0
Email 94336 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?
Individual participant data that underlie the results reported after deidentification.
When will data be available (start and end dates)?
Data are available beginning 3 months and ending 5 years following article publication.
Available to whom?
Researchers conducting meta-analyses to be submitted to peer-review who provide a methodologically sound proposal.
Available for what types of analyses?
meta-analyses
How or where can data be obtained?
Proposals should be directed to [email protected] To gain access, data requesters will need to agree to a data access agreement. Data are available for 5 years after the article publication.


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
No additional documents have been identified.