Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000470796
Ethics application status
Approved
Date submitted
17/04/2013
Date registered
24/04/2013
Date last updated
30/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing an online intervention to improve the sun protective behaviour of Australian adults.
Scientific title
Testing an online intervention which utilises the theory of planned behaviour to improve the sun protective behaviour of Australian adults.
Secondary ID [1] 282359 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sun preventative-behaviours 288932 0
Condition category
Condition code
Public Health 289271 289271 0 0
Health promotion/education
Cancer 289317 289317 0 0
Non melanoma skin cancer
Cancer 289318 289318 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interactive intervention will be delivered during one online session lasting between 20 and 25 minutes. The intervention will address 3 different constructs, (1) designed to encourage supportive sun protection related attitudes and beliefs, (2) fostering perceptions of friendship group normative support for sun protection and (3) increase perceptions of control/self-efficacy over using sun protection. A series of questions/ quizzes will be used to encourage supportive sun protection related attitudes and beliefs. Animated scenarios depicting situations in which one character is faced with opposition from an important referent to performing sun protective behaviour will be used to foster perceptions of friendship group normative support for sun protection. A series of questions will be used to prompt participants to consider how they would respond and how they may prevent the situation from occurring. An increase in perception of control/self-efficacy over using sun protection will be the aim of a set of animated scenarios and questions which ask participants to consider scenario specific barriers to sun protective behaviour and to suggest solutions to the barriers. Increasing intention to sun protect will be addressed through setting sun safe goals and through the creation of a contract outlining intention.
Intervention code [1] 286986 0
Prevention
Intervention code [2] 286987 0
Lifestyle
Intervention code [3] 286988 0
Behaviour
Comparator / control treatment
Participants will be randomly allocated to the intervention group (n = 200), the information only group (n = 200) or the control group (n=20). The information only group will be asked to view an 8 minute online DVD and three fact sheets relating to sun-protective behaviour which are currently available from Cancer Council Queensland’s website.

The control group will not be asked to do anything beyond completing the 3 questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 289376 0
Primary Outcome 1: Participants’ sun protective-behaviour as measured by self-report through the use of an online questionnaire developed by the researchers, using standard theory of planned behaviour items.
Timepoint [1] 289376 0
Timepoint: at baseline, immediately following intervention and at 1 and 4 weeks post intervention
Primary outcome [2] 289377 0
Primary Outcome 2: Participants’ intentions to sun-protect as measured by self-report through the use of an online questionnaire developed by the researchers, using standard theory of planned behaviour items.
Timepoint [2] 289377 0
Timepoint: at baseline, immediately following intervention and at 1 and 4 weeks post intervention
Secondary outcome [1] 302371 0
Secondary Outcome 1: Participants’ attitude toward sun-protection as measured by self-report through the use of an online questionnaire developed by the researchers, using standard theory of planned behaviour items.
Timepoint [1] 302371 0
Timepoint: at baseline, immediately following intervention and at 1 and 4 weeks post intervention
Secondary outcome [2] 302372 0
Secondary Outcome 2: Participants’ perception of normative support for sun-protection as measured by self-report through the use of an online questionnaire developed by the researchers, using standard theory of planned behaviour items.
Timepoint [2] 302372 0
Timepoint: at baseline, immediately following intervention and at 1 and 4 weeks post intervention
Secondary outcome [3] 302373 0
Secondary Outcome 3: Participants’ perception of control/self-efficacy toward sun-protection as measured by self-report through the use of an online questionnaire developed by the researchers, using standard theory of planned behaviour items.
Timepoint [3] 302373 0
Timepoint: at baseline, immediately following intervention and at 1 and 4 weeks post intervention

Eligibility
Key inclusion criteria
Eligibility criteria include male and female adults, living in metropolitan, regional, and coastal areas of Queensland, Australia.
Minimum age
18 Years
Maximum age
No limit
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)
Participants from a previous research study relating to sun protection who have already provided their consent to be contacted for participation in further research studies, will receive an email invitation to participate in the main research study.

Additionally, Australian adults (approximately equal numbers of males and females) living in metropolitan, regional and coastal areas will be approached via QUT media releases, through use of recruitment notices in newsletters and newspapers, radio stations, and community billboards, through QUT classifieds and websites and email lists and through snow balling techniques.
Participants will be provided with information via email on a participant recruitment flyer. They will be provided with an online link to the participant information sheet and will provide their consent to participate by ticking a box indicating they agree to participate. Participants will be randomly allocated to their treatment group via a computer generated number sequence after completion of the first questionnaire.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting participants who have completed the first questionnaire will be randomised in a 200:200:20 ratio to the intervention or information only or control group using a computer-generated random number sequence.
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/03/2013
Actual
5/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
420
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 287126 0
Government body
Name [1] 287126 0
Australian Research Council
Country [1] 287126 0
Australia
Funding source category [2] 287127 0
Charities/Societies/Foundations
Name [2] 287127 0
Cancer Council Queensland
Country [2] 287127 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Kelvin Grove Campus
Cnr Musk and Victoria Park Rd
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 285899 0
None
Name [1] 285899 0
Address [1] 285899 0
Country [1] 285899 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289133 0
University Human Research Ethics Committee, Queensland University of Technology
Ethics committee address [1] 289133 0
Queensland University of Technology, 88 Musk Avenue Kelvin Grove Campus, GPO Box 2434, BRISBANE QLD 4001
Ethics committee country [1] 289133 0
Australia
Date submitted for ethics approval [1] 289133 0
Approval date [1] 289133 0
20/12/2012
Ethics approval number [1] 289133 0
1200000658

Summary
Brief summary
The aim of this study is to evaluate the effect of an online intervention in improving the sun protective behaviour of Australian adults. Who is it for? You may be eligible to join this study if you are aged 18 years or above and live in metropolitan, regional or coastal areas of Queensland, Australia. Trial details: Participants in this trial will be randomly (by chance) allocated to one of three groups: the intervention group, the information only group, or the control group. Participants in the intervention group will receive the online intervention which focuses on encouraging supportive sun protective attitudes and beliefs, fostering perceptions of normative support for sun protection behaviour and increasing perceptions of control/self-efficacy over using sun protection. It will be delivered during one online session lasting between 20 and 25 minutes. Participants in the information only group will be asked to view a short online DVD and three fact sheets relating to sun-protective behaviour which are currently available from Cancer Council Queensland’s website. Data on intentions to sun protect and sun protection behaviour will be collected via questionnaire immediately prior to the intervention (Time 1), immediately following the intervention (Time 2) and at one week (Time 3) and four weeks (Time 4) post-intervention. The control group will not be asked to do anything beyond completing the 3 questionnaires. The study will provide valuable information about the effectiveness of the intervention in improving the sun protective behaviour of Australian adults – a population which has the highest incident rates of skin cancer in the world (Queensland).
Trial website
http://sunsafestudy.com.au
Trial related presentations / publications
Katherine M. White, Ross McD. Young, Anna L. Hawkes, Catherine Cleary, Stuart Leske, Louise Starfelt, Kylie Wihardjo (2013, April). A randomised controlled trial of an online theory-based intervention to improve adult Australians' sun-protective behaviours. Paper presented at the APS Health Psychology Conference Cairns
Public notes

Contacts
Principal investigator
Name 39402 0
Prof Katherine White
Address 39402 0
School of Psychology and Counselling, Queensland University of Technology, Victoria Park Road, Kelvin Grove. Brisbane, Queensland 4059, AUSTRALIA
Country 39402 0
Australia
Phone 39402 0
+61 07 3138 4689
Fax 39402 0
Email 39402 0
km.white@qut.edu.au
Contact person for public queries
Name 39403 0
Prof Katherine White
Address 39403 0
School of Psychology and Counselling, Queensland University of Technology, Victoria Park Road, Kelvin Grove. Brisbane, Queensland 4059, AUSTRALIA
Country 39403 0
Australia
Phone 39403 0
+61 07 3138 4689
Fax 39403 0
Email 39403 0
km.white@qut.edu.au
Contact person for scientific queries
Name 39404 0
Prof Katherine White
Address 39404 0
School of Psychology and Counselling, Queensland University of Technology, Victoria Park Road, Kelvin Grove. Brisbane, Queensland 4059, AUSTRALIA
Country 39404 0
Australia
Phone 39404 0
+61 07 3138 4689
Fax 39404 0
Email 39404 0
km.white@qut.edu.au

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

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