ISRCTN ISRCTN15189062
DOI https://doi.org/10.1186/ISRCTN15189062
Secondary identifying numbers N/A
Submission date
01/02/2016
Registration date
19/02/2016
Last edited
26/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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?
NIHR Public Health Research programme (UK)

Who is the main contact?
Dr John Holmes (scientific)

Contact information

Dr John Holmes
Scientific

Section of Public Health, ScHARR
30 Regent Street
Sheffield
S1 4DA
United Kingdom

ORCiD logoORCID ID 0000-0001-9283-2151
Phone +44 114 222 6384
Email john.holmes@sheffield.ac.uk

Study information

Study designProspective observational longitudinal study
Primary study designObservational
Secondary study designLongitudinal study
Study setting(s)Other
Study typePrevention
Participant information sheet No patient information sheet available and the study is surveying members of the general public
Scientific titleThe effectiveness of promotional campaigns associated with revised UK drinking guidelines: An evaluation of a prospective natural experiment
Study objectivesResearch 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(s)University of Sheffield School of Health and Related Research ethics committee, 18/11/2015, ref: 006373
Health condition(s) or problem(s) studiedAlcohol consumption
InterventionOnce 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 typeBehavioural
Primary outcome measureAlcohol 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 measures1. 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 study start date01/02/2015
Completion date31/10/2018

Eligibility

Participant type(s)All
Age groupAdult
Lower age limit16 Years
SexBoth
Target number of participants77,400 (43 month samples of n=1,800)
Total final enrolment74388
Key inclusion criteria1. Aged 16 years and over
2. Living in private households in England
Key exclusion criteriaAged under 16 years of age.
Date of first enrolment01/03/2014
Date of final enrolment31/10/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

University of Sheffield
School of Health and Related Research
30 Regent Street
Sheffield
S1 4DA
United Kingdom
University College London
HBRC
1-19 Torrington Place
London
WC1E 7HB
United Kingdom
University of Nottingham
Clinical Sciences Building
Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Sponsor information

University of Sheffield
University/education

Western Bank
Sheffield
S10 2TN
England
United Kingdom

ROR logo "ROR" https://ror.org/05krs5044

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date31/03/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe 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).
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2020 26/01/2021 Yes No

Editorial Notes

24/11/2017: Internal review.
02/03/2016: Internal review.