Condition category
Mental and Behavioural Disorders
Date applied
06/10/2015
Date assigned
12/10/2015
Last edited
21/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Restricting or banning alcohol advertising may be a cost-effective way to reduce excessive drinking, but there is a lack of evidence to support this. Studies have indicated that exposure to alcohol advertising may increase alcohol consumption by small amounts, but previous research has focused mainly on moderate drinkers. There is some evidence suggesting that heavy drinkers may be particularly susceptible to the influence of alcohol advertising. As yet there has not been an adequately sized study to test the effect of viewing alcohol advertising on alcohol consumption among heavy drinkers specifically. Producing advertising that warns about the negative consequences of alcohol use is an additional strategy to reduce harmful alcohol consumption. There is limited evidence regarding whether viewing alcohol warning advertising is effective in reducing alcohol consumption, and there is some indication that heavy drinkers may actually be more likely to consume alcohol after viewing alcohol warnings. The main aim of this study is to estimate the immediate impact of viewing alcohol promoting and alcohol warning advertisements on alcohol consumption in young adult heavy drinkers. A secondary aim is to identify the psychological processes that might explain any observed effects.

Who can participate?
Young adults aged 18-25 who are heavy drinkers (i.e., score above a cut-off on a measure of typical alcohol consumption).

What does the study involve?
Participants attend a one-hour session in which they are randomly assigned to view either alcohol promoting adverts, alcohol warning adverts, or non-alcohol adverts, before being given the opportunity to consume alcoholic and non-alcoholic drinks in a taste test.

What are the possible benefits and risks of participating?
There are no specific benefits to taking part, other than having the opportunity to contribute to research, and the financial reimbursement for taking part (£35). There are no foreseeable risks of taking part in this study. We have attempted to minimise any discomfort, although participants may find some of the tasks a little uninteresting and some of the questions quite personal in nature.

Where is the study run from?
London South Bank University (UK).

When is study starting and how long is it expected to run for?
March 2014 to January 2016.

Who is funding the study?
National Institute for Health Research School for Public Health Research and the Department of Health Policy Research Unit (UK).

Who is the main contact?
Prof Theresa Marteau (tm388@medschl.cam.ac.uk)
Dr Kaidy Stautz (ks704@medschl.cam.ac.uk)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kaidy Stautz

ORCID ID

Contact details

Behaviour and Health Research Unit
Institute of Public Health
University of Cambridge
Cambridge
CB2 0SR
United Kingdom

Type

Public

Additional contact

Prof Theresa Marteau

ORCID ID

Contact details

Behaviour and Health Research Unit
Institute of Public Health
University of Cambridge
Cambridge
CB2 0SR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Impact of alcohol promoting and alcohol warning advertisements on alcohol consumption in heavy drinking young adults: a laboratory-based experiment

Acronym

Study hypothesis

H1. Viewing alcohol promoting advertisements increases alcohol consumption in heavy drinkers.
H2. Viewing alcohol warning advertisements increases alcohol consumption in heavy drinkers.
H3. Stronger positive affective responses to advertisements partially mediate the effects hypothesised in H1 and H2.
H4. Stronger implicit alcohol approach motivation and attentional bias towards alcohol partially mediate the effects hypothesised in H1 and H2.
H5. Higher levels of exposure to alcohol-related advertising will result in greater alcohol consumption.

Ethics approval

1. University of Cambridge Psychology Research Ethics Committee, 19/05/2015, ref: Pre.2015.032
2. London South Bank University Research Ethics Committee, 18/06/2015, ref: UREC 1534

Study design

Between-participants experimental design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Alcohol consumption

Intervention

Participants will be randomly assigned to one of three conditions:
1. Exposure to alcohol promoting advertisements
2. Exposure to alcohol warning advertisements
3. Exposure to non-alcohol advertisements (control condition)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Alcohol consumption, calculated by measuring the volume (ml) of alcoholic and placebo alcoholic beverages remaining after completion of a taste test, and calculating amount consumed as a percentage of amount available. The taste test will be completed following exposure to advertisements.

Secondary outcome measures

1. Affective responses to advertisements will be assessed by subjective reports of pleasure (negative to positive) and arousal (relaxed to alert) whilst viewing advertisements
2. Implicit alcohol approach motivation will be assessed using an Implicit Association Test focusing on implicit approach versus avoidance of alcohol. This will be measured following exposure to advertisements and prior to the taste test
3. Attentional bias towards alcohol will be assessed using the Addiction-Stroop Test with alcohol-related words. This will be measured following exposure to advertisements and prior to the taste test

Overall trial start date

02/03/2014

Overall trial end date

29/01/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Current heavy alcohol user, defined as scoring 5 or above on the Alcohol Use Disorders Identification Test (AUDIT)-C
2. Aged 18-25

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

204

Participant exclusion criteria

1. Currently pregnant
2. Currently taking any medication, including antibiotics
3. Detectable levels of alcohol in breath on the test day (assessed by breathalyser)

Recruitment start date

14/07/2015

Recruitment end date

29/01/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

London South Bank University
SE1 6LN
United Kingdom

Sponsor information

Organisation

University of Cambridge (UK)

Sponsor details

Behaviour and Health Research Unit
Institute of Public Health
University of Cambridge
Cambridge
CB2 0SR
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research - School for Public Health Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

UK Department of Health Policy Research Program (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes