Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000846022
Ethics application status
Approved
Date submitted
24/09/2010
Date registered
7/10/2010
Date last updated
15/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of awareness of study design on alcohol consumption reports in healthy university students
Scientific title
In healthy university students, does awareness of study design and treatment group allocation influence alcohol consumption?
Secondary ID [1] 252749 0
NIL
Universal Trial Number (UTN)
U1111-1117-2211
Trial acronym
ESDA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Harmful drinking 258250 0
The influence of research design on participant behaviour (the Hawthorne effect) 258308 0
Most effective way of debriefing trial participants 270786 0
Condition category
Condition code
Public Health 258429 258429 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Effects of Study Design and Allocation (ESDA)
Variation is the study description: Group A: participants advised they are in a cohort study at enrolment however no definition of this term is provided by the investigators; Group B: participants advised they are in a randomised controlled trial (RCT) of an alcohol educational intervention at enrolment however no definition of this term is provided by the investigators; Group C: participants advised they are in an intervention group of an alcohol educational intervention at enrolment however no definition of this term is provided by the investigators. Participants are asked to complete two short web-based surveys a month apart via an email. The baseline survey contains questions on alcohol intake and social behaviour. Participant whose answers indicates a moderate to high level of alcohol intake (indicated by a score of 4 or more on the Alcohol Use Disorders Identification Test – Consumption subscale [AUDIT-C] – ) are randomised to one of three groups (A, B or C). Those who score less than 4 on the AUDIT-C are provided with a link to Alcohol: The Basics, a page containing information about effects of alcohol, safe drinking levels and problems associated with drinking, such as drink-driving. Participants in the three experimental groups (A-C) are also given access the Alcohol: The Basics material via a hyperlink. The differences between groups are solely in the way the study is described to participants. Each participant is told they will be sent another survey by email in a month’s time. The second survey contains 8 questions about drinking patterns over the past month and their impressions of the study
Supplementary Trial: Trial of Ethical Debriefing (TED)
After the survey is completed, all study participants who completed the baseline survey will be randomised to one of two groups (A and B) to receive information about the element of deception involved which the trial, the rational behind this and a summary of results.
Group A will receive an email in with a brief introduction reminding participants about the study they were involved with, followed by Debriefing Information. The email will invite them to follow an embedded link to information about the protocol and a summary of the results. The link will take them to a webpage containing two further links. One link will connect to the published ESDA protocol, the other link will connect to a summary of results.
Group B will receive an email containing a brief introduction reminding participants about the study they were involved in and will invite them to follow an embedded link to further information about the study. The link will take them to a webpage where the Debriefing Information contained in the body of the Group A email, will be provided followed by two further links. One link will connect to the published ESDA protocol, the other link will connect to a summary of results.
The links will remain active for four weeks after the last email is sent.
Intervention code [1] 257267 0
Other interventions
Comparator / control treatment
Main Survey - Group A: participants will be advised they are in a cohort study at enrolment however no definition of this term is provided by the investigators; Group B: participants will be advised they are in a randomised controlled trial (RCT) at enrolment however no definition of this term is provided by the investigators; Group C: participants will be advised they are in an intervention group at enrolment however no definition of this term is provided by the investigators.
Additional Trial of Ethical Debriefing - Group A will be provided with Debriefing Information in the body of an email with a link to the published ESDA protocol and results summary. Group B will be invited by email to follow a link to Debriefing Information and further links to the published ESDA protocol paper and results summary.
Control group
Active

Outcomes
Primary outcome [1] 259275 0
Self-reported alcohol consumption measured using the Alcohol Use Disorders Identification Test (AUDIT C)
Timepoint [1] 259275 0
1 month after exposure to experimental condition
Primary outcome [2] 279797 0
Supplementary Trial: Trial of Ethical Debriefing
Numbers who click Protocol link (Groups A and B)
Timepoint [2] 279797 0
After completion of trial and analyses of results.
Primary outcome [3] 279798 0
Supplementary Trial: Trial of Ethical Debriefing
Numbers who click Results link (Groups A and B)
Timepoint [3] 279798 0
Supplementary Trial: Trial of Ethical Debriefing
After completion of trial and analyses of results.
Primary outcome [4] 279799 0
Supplementary Trial: Trial of Ethical Debriefing
Time spent on Results page (Groups A and B)
Timepoint [4] 279799 0
Supplementary Trial: Trial of Ethical Debriefing
After completion of trial and analyses of results.
Secondary outcome [1] 265697 0
Nil
Timepoint [1] 265697 0
Nil
Secondary outcome [2] 294470 0
Supplementary Trial: Trial of Ethical Debriefing
Time spent on Debrief page (For Group B only)
Timepoint [2] 294470 0
Supplementary Trial: Trial of Ethical Debriefing
After completion of trial and analyses of results.

Eligibility
Key inclusion criteria
English speaking university students over the age of 17 years
Minimum age
17 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)
Invitations to participate will be distributed to an entire university student population via their student email addresses. After reading the information sheet and consent form, those who chose to participate in the study will show their consent by clicking on an embedded link which will take them to the survey. Participants whose survey answers indicate a moderate to high level of alcohol intake (indicated by a score of 4 or more on the Alcohol Use Disorders Identification test – Consumption subscale [AUDIT-C]) will be randomised to one of three groups. Allocation is concealed as any participant eligible for randomisation (according to their answers) is autmoatically assigned to one of the three groups. This automated allocation occurrs as they are completing the study, by means of an computer program. Group A will be told they are in a cohort design, Group B will be told they are in the control arm of a randomised controlled trial of an alcohol educational intervention, Group C will be told they are in the intervention arm of a randomised controlled trial of an alcohol educational intervention. All groups will be presented with a link to a short piece of educational material about alcohol.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Supplementary Trial: Trial of Ethical Debriefing (TED)
Participants will be randomised to one of two debriefing methods 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
16/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5853
Accrual to date
Final
Recruitment outside Australia
Country [1] 2934 0
New Zealand
State/province [1] 2934 0
South Island

Funding & Sponsors
Funding source category [1] 257708 0
Government body
Name [1] 257708 0
Australian Research Council
Country [1] 257708 0
Australia
Primary sponsor type
Individual
Name
A/Prof Kypros Kypri
Address
University of Newcastle. School of Medicine and Public Health, Level 3, David Maddison Building, Corner Watt and King Sts, Newcastle. NSW 2300
Country
Australia
Secondary sponsor category [1] 256925 0
None
Name [1] 256925 0
Address [1] 256925 0
Country [1] 256925 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259743 0
University of Otago Ethics Committee
Ethics committee address [1] 259743 0
364 Leith Walk, Dunedin 9016. PO Box 56, Dunedin 9054, New Zealand
Ethics committee country [1] 259743 0
New Zealand
Date submitted for ethics approval [1] 259743 0
Approval date [1] 259743 0
25/07/2010
Ethics approval number [1] 259743 0
1/10/0148

Summary
Brief summary
Simply participating in a research study has the potential to modify participants’ behaviour in ways that can bias research findings (the ‘Hawthorne effect’); however there is little detailed study of how this works. We aim to study these effects in order to improve study designs and inform the interpretation of existing findings. In particular, the findings of this research will assist us in the interpretation of a study currently occurring at seven New Zealand universities. In that study participants complete brief web-based alcohol screening and those with hazardous drinking are then randomly allocated to a control group or to receive assessment and personalised feedback on their drinking.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31685 0
Address 31685 0
Country 31685 0
Phone 31685 0
Fax 31685 0
Email 31685 0
Contact person for public queries
Name 14932 0
Amanda Wilson
Address 14932 0
School of Medicine and Public Health
Level 3, David Maddison Clinical Sciences Building
University of Newcastle, Callaghan NSW 2308 Australia
Country 14932 0
Australia
Phone 14932 0
+61 2 4913 8297
Fax 14932 0
+61 2 4913 8148
Email 14932 0
amanda.wilson@newcastle.edu.au
Contact person for scientific queries
Name 5860 0
Kypros Kypri
Address 5860 0
School of Medicine and Public Health
Level 3, David Maddison Clinical Sciences Building
University of Newcastle, Callaghan NSW 2308 Australia
Country 5860 0
Australia
Phone 5860 0
+61 2 4913 8231
Fax 5860 0
+61 2 4913 8148
Email 5860 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
EmbaseEffects of Study Design and Allocation on participant behaviour - ESDA: Study protocol for a randomized controlled trial.2011https://dx.doi.org/10.1186/1745-6215-12-42
EmbaseEffects of study design and allocation on self-reported alcohol consumption: Randomized trial.2015https://dx.doi.org/10.1186/s13063-015-0642-0
N.B. These documents automatically identified may not have been verified by the study sponsor.