Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000255886
Ethics application status
Approved
Date submitted
28/02/2012
Date registered
29/02/2012
Date last updated
29/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Does participant awareness of study focus and assessment of drinking influence subsequent alcohol consumption?
Scientific title
Does participant awareness of study focus and assessment of drinking influence subsequent alcohol consumption?
Secondary ID [1] 279763 0
NIL
Universal Trial Number (UTN)
U1111-1127-3643
Trial acronym
HARBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social desirability bias 285628 0
Condition category
Condition code
Public Health 285821 285821 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behavioural: All participants will be randomised to one of three web-based surveys (Groups A, B or C). All participants will answer the same questions on lifestyle behviours including socialisation, fast food intake, drinking and physical activity. Group A will be told they are completing a Lifestyle Survey while Group B will be told the focus of the survey is alcohol intake. Group C will also be told the focus of the survey is alcohol intake but they will answer a series of extra questions about the impact of alcohol on their behaviour and lifestyle before answering the same lifestyle questions as Group A and B. All surveys will take less than 10 minutes to complete. All participants will be asked to complete a second, follow-up survey 4 weeks later and this will take less than 5 minnutes to complete.
Intervention code [1] 284079 0
Behaviour
Comparator / control treatment
Comparison of awareness of study focus and assessment of drinking
Control group
Active

Outcomes
Primary outcome [1] 286334 0
Self-reported volume of alcohol consumption in the previous 4 weeks measured using an abbreviated version of the Alcohol Use Disorders Identification Test (AUDIT C).
Timepoint [1] 286334 0
1 month follow-up
Secondary outcome [1] 295625 0
Self-reported frequency of drinking in the previous 4 weeks measured using an abbreviated version of the Alcohol Use Disorders Identification Test (AUDIT C).
Timepoint [1] 295625 0
Amount per occassion over the 4 week period following baseline survye completion.

Eligibility
Key inclusion criteria
English speaking adults
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
Students will be invited to participate via an email sent to their student addresses by each participating university. This email will contain a hyperlink to a webpage with study information sheet and a registration box for their email address. Once they have entered their email address, which is taken as consent to partiicpate in the study, an email is sent by the research team to them with a link to the survey. Clicking on this link will randomly assign participants to one of three different surveys groups A, B or C. Randomisation will occur without their knowledge.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be effected automatically by computer using a random number generator.
Masking / blinding
Blinded (masking used)
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4000
Accrual to date
Final
Recruitment outside Australia
Country [1] 4070 0
New Zealand
State/province [1] 4070 0
Dunedin

Funding & Sponsors
Funding source category [1] 284659 0
Government body
Name [1] 284659 0
Australian Research Council
Country [1] 284659 0
Australia
Primary sponsor type
Individual
Name
A/Pro Kypros Kypri
Address
University of Newcastle, School of Medicine and Public Health, Callaghan Drive, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 283565 0
None
Name [1] 283565 0
Address [1] 283565 0
Country [1] 283565 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286662 0
University of Otago Human Ethics Committee
Ethics committee address [1] 286662 0
University of Otago
Clocktower Building
364 Leith Walk
Dunedin 9016
Ethics committee country [1] 286662 0
New Zealand
Date submitted for ethics approval [1] 286662 0
17/01/2012
Approval date [1] 286662 0
20/01/2012
Ethics approval number [1] 286662 0
Variation to 10/148

Summary
Brief summary
This study aims to test two experimental hypotheses:
1) A comparison of awareness and lack of awareness of study focus, and
2) Assessment of awareness versus non-awareness of monitoring behaviour.
The focus is on whether answering specific questions within the research assessment questionnaire causes participants to think differently about their behaviour, and to subsequently act upon it.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33659 0
Address 33659 0
Country 33659 0
Phone 33659 0
Fax 33659 0
Email 33659 0
Contact person for public queries
Name 16906 0
Dr Amanda Wilson
Address 16906 0
University of Newcastle, School of Medicine and Public Health, Callaghan Drive, Callaghan 2308 NSW
Country 16906 0
Australia
Phone 16906 0
+61 2 49138297
Fax 16906 0
Email 16906 0
amanda.wilson@newcastle.edu.au
Contact person for scientific queries
Name 7834 0
A/Prof Kypros Kypri
Address 7834 0
University of Newcastle, School of Medicine and Public Health, Callaghan Drive, Callaghan 2308 NSW
Country 7834 0
Australia
Phone 7834 0
+61 2 49138231
Fax 7834 0
Email 7834 0
kypros.kypri@newcastle.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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomized trial seeking to induce the Hawthorne effect found no evidence for any effect on self-reported alcohol consumption online.2019https://dx.doi.org/10.1016/j.jclinepi.2018.11.016
N.B. These documents automatically identified may not have been verified by the study sponsor.