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The influence of awareness of study design on alcohol consumption reports in healthy university students

In healthy university students, does awareness of study design and treatment group allocation influence alcohol consumption?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000846022
Acronym
ESDA
Enrollment
5853
Registered
2010-10-07
Start date
2010-08-16
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 ed

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.

Sponsors

A/Prof Kypros Kypri
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
17 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

English speaking university students over the age of 17 years

Exclusion criteria

Nil

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 29, 2026