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
Type
Scientific
Primary contact
Dr John Holmes
ORCID ID
http://orcid.org/0000-0001-9283-2151
Contact details
Section of Public Health
ScHARR
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 114 222 6384
john.holmes@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effectiveness of promotional campaigns associated with revised UK drinking guidelines: An evaluation of a prospective natural experiment
Acronym
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
Observational
Secondary study design
Longitudinal study
Trial setting
Other
Trial type
Prevention
Patient information sheet
No patient information sheet available and the study is surveying members of the general public
Condition
Alcohol consumption
Intervention
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
Behavioural
Phase
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
01/02/2015
Overall trial end date
31/10/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 16 years and over
2. Living in private households in England
Participant type
All
Age group
Adult
Gender
Both
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
01/03/2014
Recruitment end date
31/10/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Sheffield
School of Health and Related Research
30 Regent Street
Sheffield
S1 4DA
United Kingdom
Trial participating centre
University College London
HBRC
1-19 Torrington Place
London
WC1E 7HB
United Kingdom
Trial participating centre
University of Nottingham
Clinical Sciences Building
Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
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
31/03/2019
Participant level data
Not expected to be available
Results - basic reporting
Publication summary