Condition category
Mental and Behavioural Disorders
Date applied
19/11/2016
Date assigned
21/11/2016
Last edited
27/04/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Previous research has suggested that labels indicating low or light versions of products with health harms could lead people to consume more as they appear to be less harmful. However, it is not clear whether labelling alcohol as low in strength could also have such effects. The aim of this study is to find out whether the use of low alcohol labels increases consumption of wine and beer.

Who can participate?
Healthy volunteers, aged 18 or over, who consume alcohol weekly

What does the study involve?
The study takes place in a laboratory setting that mimics a “bar” environment, located in central London. Participants are randomly allocated to taste one of test three glasses of wine or beer, labelled as having either average, low or super low alcohol content. The drinks vary only in the labels used to describe the drinks, not in the actual drinks. Participants are asked to rate the quality of the drinks and are then told that they can consume the remaining drinks whilst answering questions regarding their drinking habits and motivations. The total volume of drink consumed, product appeal and perceived alcohol strength are all measured.

What are the possible benefits and risks of participating?
The findings from this study will provide evidence of the impact of low alcohol labels on beer and wine consumption . This study is considered to be low risk and no side effects are expected. Since participants will drink alcohol in this study, breathalysers will be used to ensure that at the end of the study participants are not intoxicated (participants will only be able to consume a maximum of 2.5 units of alcohol since all the drinks will have a low alcohol content). If they are over the driving limit, they will be asked to remain in the lab until the effects of the alcohol have worn off, or to take public transportation when leaving the testing venue. Participants who insist on leaving the lab before they are sober will be asked to sign a waiver stating they are aware of their breath alcohol concentration.

Where is the study run from?
Testing will take place in a bar lab located in central London. The study is run from the Behaviour and Health Research Unit at the University of Cambridge (UK)

When is the study starting and how long is it expected to run for?
July 2015 to February 2017

Who is funding the study?
Department of Health Policy Research Programme (UK)

Who is the main contact?
Prof. Theresa Marteau

Trial website

Contact information

Type

Scientific

Primary contact

Prof Theresa Marteau

ORCID ID

http://orcid.org/0000-0003-3025-1129

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Impact of low alcohol labels on consumption: a bar lab experiment

Acronym

Study hypothesis

The research question is whether labelling alcohol products to denote low levels of alcohol by volume leads to self-licensing whereby people consume more of an alcoholic beverage when it is labelled as “low” compared with when it is labelled as regular strength. The hypothesis is that more alcohol is consumed when equivalent beverages are labelled to denote a lower strength product than when they are labelled as regular strength.

Ethics approval

Cambridge Psychology Research Ethics Committee, 05/11/2015, ref: PRE.2015.083

Study design

Randomised controlled trial

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 contact details to request a participant information sheet.

Condition

Excessive alcohol consumption

Intervention

Two between-subjects experiments (for (a) wine and (b) beer) with one independent factor of three levels corresponding to the label that accompanies drinks (wine or beer) for consumption.

The trial has three different intervention arms. Participants are randomly allocated to taste test three glasses of wine or beer, with all three glasses having one of three possible labels:
1. Label displaying the average %ABV on the market, 12.9% for wine and 4.2% for beer (without any verbal descriptors of strength)
2. Label displaying the verbal descriptor "Low" combined with either 8%ABV for wine or 3%ABV for beer
3. Label displaying the verbal descriptor "Super Low" combined with either 4%ABV for wine or 1%ABV for beer

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Total volume of drink consumed during the taste-test task measured in millilitres (ml). The taste-test task takes place immediately post-intervention.

Secondary outcome measures

1. Product appeal: measured using validated questionnaire items with answers given on Likert-type rating scales. The measurement will take place immediately post-intervention with the labels (differing according to randomisation) displayed for participants to see
2. Perceived alcohol strength: measured using validated questionnaire items with answers given on Likert-type rating scales. The measurement will take place immediately post-intervention with the labels (differing according to randomisation) displayed for participants to see
3. Other indices of appeal: measured using validated questionnaire items with answers given on Likert-type rating scales. The measurement will take place immediately post-intervention with the labels (differing according to randomisation) displayed for participants to see

Overall trial start date

16/07/2015

Overall trial end date

28/02/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult men and women (above 18 years of age)
2. Weekly wine/beer drinker

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

264

Participant exclusion criteria

1. Under 18 years of age
2. Non-weekly wine/beer drinker
3. Pregnancy (women only)
4. Medication use (including antibiotics)
5. History of neurological or psychiatric disorders

Recruitment start date

28/11/2016

Recruitment end date

28/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Cambridge

Sponsor details

Trinity Lane
Cambridge
CB2 1TN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Department of Health Policy Research Programme (Policy Research Unit in Behaviour and Health [PR-UN-0409-10109]) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Planned submission of the main results of this study for publication in a high-impact factor journal
2. Planned dissemination of the results to the public, policy makers and other researchers through targeted social media

IPD sharing plan
The datasets generated during and/or analysed during the current study will be available upon request from Prof. Theresa Marteau.

Intention to publish date

31/07/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29698021

Publication citations

Additional files

Editorial Notes

27/04/2018: Publication reference added.