Condition category
Mental and Behavioural Disorders
Date applied
09/05/2018
Date assigned
11/05/2018
Last edited
10/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
There is growing interest from policymakers and producers to extend the range of lower strength alcohol products above the current cap of 1.2% ABV set out in national legislation. There is however an absence of evidence concerning the impact on consumption of labelling alcohol products as lower in strength. A recent study found that the total amount of wine and beer consumed increased as the label on the drink denoted successively lower alcohol strength. Participants drank most when drinks were labelled as Super Low and least when labelled as Regular strength. However, the design of this study did not allow it to show whether the effects of the lower alcohol strength labelling stemmed from the verbal or the numerical descriptor of strength since all the labels denoting lower alcohol strength contained a combination of verbal and numerical information (% ABV). This study aims to fill this gap by examining which aspect of the label for a lower strength wine increases consumption, the verbal descriptor (Super Low), the percentage alcohol by volume (4% ABV), or their combination.

Who can participate?
Healthy volunteers, aged 18 or over, who consume wine at least once 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 one of three groups varying only in the labels used to describe the drinks they are invited to taste, and not in the actual drinks. Participants are asked to rate the quality of the wines and are then told that they can consume the remaining wine whilst answering questions regarding their drinking habits and motivations. The total volume of drink consumed and product appeal are 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 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 wines will be of lower alcohol strength). 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?
November 2017 to October 2018

Who is funding the study?
National Institute for Health Research 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

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 different low alcohol labels on wine consumption: a bar lab experiment

Acronym

Study hypothesis

This study will aim to answer the following question: which aspect of the label for a lower strength wine increases consumption: a verbal descriptor (Super Low), the percentage alcohol by volume (4% ABV), or their combination?

Ethics approval

Cambridge Psychology Research Ethics Committee, 10/01/2018, ref: PRE.2017.095

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

A between-subjects experiment with one independent factor of three levels corresponding to the label that accompanies wine for consumption. The trial has three different intervention arms. Participants are randomly allocated to taste test three glasses of wine, with all three glasses having one of three possible labels:
Group 1: Verbal descriptor only (Super Low)
Group 2: % ABV only (4% ABV)
Group 3: Verbal descriptor AND % ABV (Super Low AND 4% ABV)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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

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.

Overall trial start date

10/11/2017

Overall trial end date

31/10/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult men and women (above 18 years of age)
2. Weekly wine drinker (consuming wine at least once a week)

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

90 adults (30 per experimental group) will be recruited via a research agency from a panel representative of the general population of England to a pilot study [with interlocking quotas set for age, gender, and SES]. We will recruit 90 people who consume alcohol and, according to prior stated preference, will sample weekly wine drinkers. The sample size of 90 participants was chosen as a pragmatic number to estimate the likely effect size of the comparison between the three groups as an internal pilot, with a view to estimating a required sample size to detect a likely effect (see Lancaster, Dodd, & Williamson, 2004). If the required total sample size for the full trial is less than 300 (incl. the 90 already tested), we will recruit the remaining sample and analyse the combined dataset (see Wittes & Brittain, 1990). If the required sample is larger than this, no further participants will be recruited and the data from the 90 participants will be written-up as a pilot study.

Participant exclusion criteria

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

Recruitment start date

21/05/2018

Recruitment end date

31/10/2018

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

National Institute for Health Research Policy Research Programme (Policy Research Unit in Behaviour and Health [PR-UN-0409-10109])

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

31/10/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes