Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001160921
Ethics application status
Approved
Date submitted
3/11/2011
Date registered
7/11/2011
Date last updated
7/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing an educational program to improve sun protective behaviour of Queensland teenagers.
Scientific title
You can still be HOT! in the shade: Testing an educational program to improve sun protective behaviour of Queensland teenagers.
Secondary ID [1] 273323 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
HOT! project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sun preventative-behaviours 279095 0
Condition category
Condition code
Public Health 279283 279283 0 0
Health promotion/education
Cancer 279300 279300 0 0
Non melanoma skin cancer
Skin 279301 279301 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention focuses on: (1) encouraging supportive sun protective attitudes and beliefs, (2) fostering perceptions of normative support for sun protection behaviour, and (3) increasing perceptions of control/self-efficacy over using sun protection. The study will involve 4 public and 4 private schools in Queensland. Intervention sessions will be facilitated by trained persons from either Cancer Council Queensland or Queensland University of Technology. Facilitators and Queensland University of Technology researcher staff will be authorised to deliver the intervention with secondary school students during school hours, and all study staff directly involved with the participants and the running of the intervention will have a current Positive Notice Blue Card (a safety check card that allows access to work with children). The facilitators and Queensland University of Technology researcher staff will follow the directions of supervising school staff regarding access to child participants and the location of testing. Testing will take place in an accessible area designated by the school principal or supervising teacher, in proximity to normal classroom activities. As required by the Health & Safety requirements for Queensland schools, the supervising teacher will be aware of the intervention testing circumstances. Assistance will be available from school staff when required. The facilitators and Queensland University of Technology researcher staff will follow the required procedures for visitors to the school.

Each intervention session of 1 hour per session and occurring once a week over a three week timeline will address a different construct. Week one will be designed to encourage supportive sun protection related attitudes and beliefs. Week two will focus on fostering perceptions of friendship group normative support for sun protection. Week three will aim to increase perceptions of control/self-efficacy over using sun protection. Activities for the intervention will include group based discussions, practical sessions on being sun safe (e.g., applying sunscreen correctly), watching relevant sun safety DVDs, and students creating their own internet and/or text message campaigns to encourage sun safety amongst young people. At the conclusion of each session, participants and facilitators will evaluate program content, materials, and delivery.
Intervention code [1] 283671 0
Prevention
Intervention code [2] 283672 0
Lifestyle
Intervention code [3] 283673 0
Behaviour
Comparator / control treatment
A no-treatment control group is used but participants randomised to the control group will be offered the opportunity to receive the intervention material at the completion of the project (a ‘wait-list control group’).
Control group
Active

Outcomes
Primary outcome [1] 279902 0
Participants' sun protective-behaviour as measured by self-report using standard theory of planned behaviour items
Timepoint [1] 279902 0
at baseline and at 1 and 4 weeks post intervention
Primary outcome [2] 279903 0
Participants' intentions to sun-protect as measured by self-report using standard theory of planned behaviour items
Timepoint [2] 279903 0
at baseline and at 1 and 4 weeks post intervention
Secondary outcome [1] 294725 0
Participants' attitude toward sun-protection as measured by self-report using standard theory of planned behaviour items
Timepoint [1] 294725 0
at baseline and at 1 and 4 weeks post intervention
Secondary outcome [2] 294726 0
Participants' perception of normative support for sun-protection as measured by self-report using standard theory of planned behaviour items
Timepoint [2] 294726 0
at baseline and at 1 and 4 weeks post intervention
Secondary outcome [3] 294727 0
Participants' perception of control/self-efficacy toward sun-protection as measured by self-report using standard theory of planned behaviour items
Timepoint [3] 294727 0
at baseline and at 1 and 4 weeks post intervention

Eligibility
Key inclusion criteria
Eligibility criteria includes male and female students aged 12 to 17 years from public and private secondary schools across metropolitan and regional areas of Queensland, Australia.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
A convenience sample of schools will be recruited using a maximum variation sampling method to ensure participating schools range in social-demographic status and geographical location. Schools will be approached to participate by the study team using an information package by phone, email and face-to-face discussions. The information package will include a letter to the school principal, background information about the study, questionnaire items, and the participant intervention workbook. Consenting schools will be requested to identify teachers (and their students) that will be accessible to the research team. Active consent will be obtained from both the student participating and their legal guardian. Consenting schools will then be randomised to the intervention or a wait-listed control group and allocated to these groups via a process involving the contacting of the holder of the allocation schedule who is “off site”.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting schools will be randomised in a 1:1 ratio to the intervention or a wait-listed control group using a computer-generated random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 4722 0
4068
Recruitment postcode(s) [2] 4723 0
4170
Recruitment postcode(s) [3] 4724 0
4551
Recruitment postcode(s) [4] 4725 0
4567
Recruitment postcode(s) [5] 4726 0
4207
Recruitment postcode(s) [6] 4727 0
4670

Funding & Sponsors
Funding source category [1] 284151 0
Government body
Name [1] 284151 0
Australian Research Council
Country [1] 284151 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Cancer Council Queensland
Address
553 Gregory Terrace
Fortitude Valley QLD 4006
Country
Australia
Secondary sponsor category [1] 269113 0
None
Name [1] 269113 0
Address [1] 269113 0
Country [1] 269113 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272114 0
University Human Research Ethics Committee, Queensland University of Technology
Ethics committee address [1] 272114 0
Ethics committee country [1] 272114 0
Australia
Date submitted for ethics approval [1] 272114 0
Approval date [1] 272114 0
15/07/2011
Ethics approval number [1] 272114 0
1100000768
Ethics committee name [2] 272115 0
Department of Education and Training
Ethics committee address [2] 272115 0
Ethics committee country [2] 272115 0
Australia
Date submitted for ethics approval [2] 272115 0
Approval date [2] 272115 0
19/09/2011
Ethics approval number [2] 272115 0
550/27/119
Ethics committee name [3] 272116 0
Catholic Education Archdiocese of Brisbane
Ethics committee address [3] 272116 0
Ethics committee country [3] 272116 0
Australia
Date submitted for ethics approval [3] 272116 0
Approval date [3] 272116 0
22/08/2011
Ethics approval number [3] 272116 0
A11.096 JS:em ref:172

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

Contacts
Principal investigator
Name 33349 0
Address 33349 0
Country 33349 0
Phone 33349 0
Fax 33349 0
Email 33349 0
Contact person for public queries
Name 16596 0
Katherine White
Address 16596 0
School of Psychology and Counselling, Queensland University of Technology, Victoria Park Road, Kelvin Grove. Brisbane, Queensland 4059
Country 16596 0
Australia
Phone 16596 0
+61 7 31384689
Fax 16596 0
+61 7 31384660
Email 16596 0
[email protected]
Contact person for scientific queries
Name 7524 0
Katherine White
Address 7524 0
School of Psychology and Counselling, Queensland University of Technology, Victoria Park Road, Kelvin Grove. Brisbane, Queensland 4059
Country 7524 0
Australia
Phone 7524 0
+61 7 31384689
Fax 7524 0
+61 7 31384660
Email 7524 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
No additional documents have been identified.