Condition category
Mental and Behavioural Disorders
Date applied
03/11/2014
Date assigned
29/12/2014
Last edited
29/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Drinkware is a charity that aims to change people’s drinking habits and help reduce alcohol abuse and the harm caused by drinking too much alcohol. This study looks at how well two different messages displayed on their website, one focusing on health risks and the other on how drinking too much alcohol can have an impact on personal appearance, do in encouraging people to do a self-assessment that gives them feedback on whether they are at risk of damaging their health or appearance and whether they then go on to seek help for their drinking habit.

Who can participate?
Anyone who uses the Drinkaware website. However, there will be a particular focus on analyzing data from women over 35 years as this group has been identified by Drinkaware as a priority target group.

What does the study involve?
People who visit the Drinkaware website between Monday 3rd November and Sunday 14th December 2014 are randomly allocated to see either a brief health risk or appearance alcohol awareness message via banner advertisement in a prominent central position on the website. If web users choose to click on this banner, they are taken to another webpage containing a second brief message reinforcing the banner advertisement and are encouraged to self-assess their drinking behaviour using an online test - the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) questionnaire. AUDIT-C is a 3-item tool designed to see if someone is drinking alcohol at levels that may lower or increase risk to health. After they have completed the AUDIT-C questionnaire, participants are directed to a webpage containing their AUDIT-C risk score feedback and an extended health risk focused or appearance focused alcohol awareness message. At the bottom of this page, participants are provided with 3 help-seeking options including a number of web links containing information and providing access to resources and tools to encourage then to reduce the amount of alcohol they drink.

What are the possible benefits and risks of participating?
The benefit of participating is the opportunity to access a range of tools to help moderate alcohol consumption and improved recognition of what constitutes problem drinking. There is a risk that individuals find out they are drinking too much and do not access any of the support materials.

Where is the study run from?
The Drinkaware website (UK)

When is the study starting and how long is it expected to run for?
November 2014 to December 2014

Who is funding the study?
1. Drinkaware (UK)
2. Public Health England (UK)

Who is the main contact?
Miss Anna Sallis
anna.sallis@phe.gov.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Anna Sallis

ORCID ID

Contact details

Public Health England
2nd Floor Skipton House
80 London Road
London
SE16LH
United Kingdom
-
anna.sallis@phe.gov.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparing web-based health and appearance framed messages to increase completion of the Audit C alcohol self-assessment tool.

Acronym

N/A

Study hypothesis

1. Hypothesis 1 (H1): There is a difference in the number of participants who start the audit c in those exposed to either a brief appearance-framed or health-risk-framed persuasive message.
2. Hypothesis 2 (H2): There is a difference in the number of participants who will complete the audit c in those exposed to a brief appearance-framed or health-risk-framed persuasive message.
3. Hypotheses 3 (H3): There is a difference in the number of participants who engage in help-seeking behaviour following exposure to either an appearance-framed or health-risk-framed persuasive message.

Ethics approval

Bristol University School of Economics, Finance and Management Research Ethics Committee, 15/09/2014

Study design

The study is a cross-sectional pragmatic randomised trial with two intervention groups.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

There is no patient information material. Participants are invited to contact an email address at Drinkaware if they would like to know about any research taking place on the website during their use of it.

Condition

Excessive alcohol consumption.

Intervention

Short health and appearance framed alcohol harms messages are presented on the homepage. Once clicked participants are taken to the Audit C alcohol self-assessment questionnaire. The AUDIT-C is a modified short form of the full 10-item AUDIT questionnaire. Once completed health or appearance framed alcohol harms messages are fed back to participants with risky drinking patterns. They are then shown 3 help-seeking web links which they can click and continue to use.

Intervention type

Phase

Not Applicable

Drug names

Primary outcome measures

1. Clicks to the audit C from home page
2. Completions of audit C

Measured between 11th November– 23rd December 2014

Secondary outcome measures

Clicks on help seeking links

Measured between 11th November– 23rd December 2014

Overall trial start date

10/11/2014

Overall trial end date

21/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Anyone accessing the Drinkaware homepage between Monday 3rd November and Sunday 14th December 2014

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

75,000 home page visits

Participant exclusion criteria

There are no exclusion criteria.

Recruitment start date

11/11/2014

Recruitment end date

23/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Public Health England
London
SE16LH
United Kingdom

Sponsor information

Organisation

Public Health England

Sponsor details

c/o Dr Elizabeth Coates
Head of Research Governance RDD
Public Health England
Porton
Salisbury
SP5 0JG
United Kingdom
-
anna.sallis@phe.gov.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Public Health England

Alternative name(s)

PHE

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes