Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000254998
Ethics application status
Approved
Date submitted
11/02/2011
Date registered
8/03/2011
Date last updated
15/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Social Desirability Bias in response to a health behaviour survey
Scientific title
Experimental study of the effects of introducing social desirability bias in responses to a health behaviour survey.
Secondary ID [1] 253395 0
Nil
Universal Trial Number (UTN)
U1111-1119-0270
Trial acronym
SDB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social desirability bias in health survey responses 260950 0
Condition category
Condition code
Public Health 259087 259087 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behavioural: All participants will be asked to complete a short (5 minute) web-based survey. The initial part of the survey will be comprised of questions about physical activity, diet, smoking and alcohol intake. All participants will answer the same questions for each section apart from alcohol where participants will be randomised to one of two groups (A or B). The Group A survey will be titled “Recent Drinking” and followed by 3 questions regarding alcohol intake over the past 4 weeks. The Group B survey will be titled “Alcohol Use Disorders” and a brief introduction will say the questions are used to identify alcohol use disorders followed by 7 behavioural questions. They will then see a heading of “Recent Drinking” followed by the same 3 questions from Group A concerning alcohol intake over the past 4 weeks. The entire web-based survey will have a median completion time of less than 5 minutes.
Intervention code [1] 257841 0
Behaviour
Comparator / control treatment
Comparision of 2 survey types.
Control group
Active

Outcomes
Primary outcome [1] 262107 0
Self-reported volume of alcohol in the previous 4 weeks.
Timepoint [1] 262107 0
At the time of the survey
Primary outcome [2] 262195 0
Self-reported frequency of drinking in the previous 4 weeks.
Timepoint [2] 262195 0
A the time of the survey.
Primary outcome [3] 262196 0
Self-reported amount consumed per typical drinking occassion in the previous 4 weeks.
Timepoint [3] 262196 0
At the time of the survey.
Secondary outcome [1] 273169 0
Nil
Timepoint [1] 273169 0
Nil

Eligibility
Key inclusion criteria
English speaking adults who are 18 years and over
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
Treatment
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 address. This email will contain a hyperlink to the study Information Sheet. Clicking on this link to complete the survey will be taken as consent. A reminder email will be sent two weeks later. All participants will be asked to complete a short web-based survey. The initial part of the survey will be comprised of questions about physical activity, diet, smoking and alcohol intake. All participants will be randomised to one of two conditions (A or B) for the alcohol questions. Randomisation will occur without their knowledge.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be effected 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
Completed
Date of first participant enrolment
Anticipated
17/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258477 0
Government body
Name [1] 258477 0
Australian Research Council
Country [1] 258477 0
Australia
Primary sponsor type
Individual
Name
A/Prof Kypors Kypri
Address
University of Newcastle, School of Medicine and Public Health, Level 3, David Maddison Building, Corner Watt and King Streets, Newcastle, NSW 2300
Country
Australia
Secondary sponsor category [1] 257618 0
None
Name [1] 257618 0
Address [1] 257618 0
Country [1] 257618 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260453 0
Human Research Ethics Committee University of Newcastle
Ethics committee address [1] 260453 0
Human Research Ethics Administration
Research Services
Research Office
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 260453 0
Australia
Date submitted for ethics approval [1] 260453 0
01/09/2010
Approval date [1] 260453 0
07/02/2011
Ethics approval number [1] 260453 0
H-2010-1243

Summary
Brief summary
This study aims to test experimental hypotheses which will assist in improving the design of behavioural intervention trials, and inform the interpretation of findings reported to date, leading to better decisions about health policy and clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32086 0
Address 32086 0
Country 32086 0
Phone 32086 0
Fax 32086 0
Email 32086 0
Contact person for public queries
Name 15333 0
Dr Amanda Wilson
Address 15333 0
University of Newcastle, School of Medicine and Public Health, Level 3, David Maddison Building, Corner Watt and King Streets, Newcastle, NSW 2300
Country 15333 0
Australia
Phone 15333 0
+61 2 49138297
Fax 15333 0
Email 15333 0
[email protected]
Contact person for scientific queries
Name 6261 0
A/Prof Kypros Kypri
Address 6261 0
University of Newcastle, School of Medicine and Public Health, Level 3, David Maddison Building, Corner Watt and King Streets, Newcastle, NSW 2300
Country 6261 0
Australia
Phone 6261 0
+61 2 49138231
Fax 6261 0
Email 6261 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.