Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status

Plain English Summary

Background and study aims
Alcohol is a major public health problem. In the UK, there were 8,416 deaths and over a million hospital admissions due to alcohol in 2013. Treating alcohol-related problems costs the NHS approximately £3.5 billion a year. Internationally, a common approach to reducing alcohol consumption is to publish low risk drinking guidelines (DG). These aim to tell the public about the risks of drinking above a particular amount of alcohol and encourage more sensible drinking behaviour. DG are promoted in various ways including TV advertising campaigns, putting information on bottle labels and by doctors discussing drinking with their patients. Despite their widespread use, little is known about whether promoting DG affects people’s behaviour or how they think about alcohol. The aim of this study is to evaluate the impact of promoting new DG has on the alcohol consumption of adults living in England.

Who can participate?
Anyone aged 16 or over who lives in a private household in England.

What does the study involve?
All participants complete questionnaires online in their own home once a month for 22 months. The questions in the questionnaires vary slightly each month but all include questions about alcohol consumption, knowledge about current drinking guidelines and the motivation and opportunity to use drinking guidelines in their own lives. Throughout the study, government and hospital records are reviewed so that the amount of alcohol related problems and injuries can be recorded.

What are the possible benefits and risks of participating?
There are no direct benefits or risks of taking part in this study.

Where is the study run from?
1. University of Sheffield (UK)
2. University College London (UK)
3. University of Nottingham (UK)

When is the study starting and how long is it expected to run for?
February 2015 to October 2018

Who is funding the study?
MicroPharm Limited (UK)

Who is the main contact?
1. Dr Geoffrey Shellswell (scientific)
2. Mr Ian Cameron (scientific)

Trial website

Contact information



Primary contact

Dr John Holmes


Contact details

Section of Public Health
30 Regent Street
S1 4DA
United Kingdom
+44 114 222 6384

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The effectiveness of promotional campaigns associated with revised UK drinking guidelines: An evaluation of a prospective natural experiment


Study hypothesis

Research Questions:
1. What is the timing, audience and content for major promotional activity following publication of revised drinking guidelines?
2. Does promotion of drinking guidelines lead to changes in trends in alcohol consumption behaviour (primary outcome), individuals’ capability, opportunity and motivation to change behaviour and alcohol-related hospital admissions (secondary outcomes)?
3. Are there any variations in effects across subgroups of the population defined by gender, age, and socioeconomic status?
4. Are there any variations in effects between those reporting recent exposure to the drinking guidelines and those not reporting recent exposure?
5. Are any changes in alcohol consumption behaviour preceded by changes in capability, opportunity and motivation to change behaviour?
6. Given the observed relationship between promotional activity and alcohol consumption behaviour, is the promotion of revised drinking guidelines a cost-effective intervention?

Ethics approval

University of Sheffield School of Health and Related Research ethics committee, 18/11/2015, ref: 006373

Study design

Prospective observational longitudinal study

Primary study design


Secondary study design

Longitudinal study

Trial setting


Trial type


Patient information sheet

No patient information sheet available and the study is surveying members of the general public


Alcohol consumption


Once a month for 22 months, participants complete questionnaires in their own homes via computer-assisted interviews conducted by Ipsos Mori interviewers. The questionnaire is an Ipsos Mori Omnibus study which we have bought questions within and therefore the full content of the questionnaire varies each month. However, it always includes sociodemographic questions and questions specific to this study which pertain to alcohol consumption, knowledge of drinking guidelines and capability, motivation and opportunity to use drinking guidelines in their own lives.

Intervention type



Drug names

Primary outcome measures

Alcohol consumption behaviour measured on a monthly basis via AUDIT-C scores collected in repeat cross-sectional surveys throughout the study period between January 2016 and October 2017, and compared to a combination of data collected in this study between November and December 2015 and data previously collected between March 2014 and October 2015.

Secondary outcome measures

1. Alternative alcohol consumption measures, specifically:
1.1. Mean weekly consumption measured on a monthly basis using graduated frequency questions in repeat cross-sectional surveys between November 2015 and October 2017
1.2. Monthly consumption measured using alcohol cleared for UK sales as recorded by HMRC
1.3. Hazardous drinking measured using full AUDIT score collected as with AUDIT-C scores
2. Behavioural antecedents of alcohol consumption, specifically capability, opportunity and motivation to change behaviour as measured by questions informed by the COM-B model of behaviour change in repeat cross-sectional surveys between November 2015 and October 2017
3. Alcohol-related harm is measured using Hospital Episode Statistics monthly
3.1. Admissions to hospital for alcohol poisoning (ICD-10: T51.0, T51.1 and T51.9)
3.2. Admissions to hospital for assaults (ICD-10: X85-Y09)

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Aged 16 years and over
2. Living in private households in England

Participant type


Age group




Target number of participants

77,400 (43 month samples of n=1,800)

Participant exclusion criteria

Aged under 16 years of age.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Sheffield
School of Health and Related Research 30 Regent Street
S1 4DA
United Kingdom

Trial participating centre

University College London
HBRC 1-19 Torrington Place
United Kingdom

Trial participating centre

University of Nottingham
Clinical Sciences Building Nottingham City Hospital Hucknall Road
United Kingdom

Sponsor information


University of Sheffield

Sponsor details

Western Bank
S10 2TN
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Results and Publications

Publication and dissemination plan

The results of the study will be communicated to a wide range of people by publishing papers in scientific journals and presenting to national and international conferences attended by different groups who may be interested (including the general public).

Intention to publish date


Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

02/03/2016: Internal review.