Condition category
Mental and Behavioural Disorders
Date applied
11/12/2019
Date assigned
21/01/2020
Last edited
06/03/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many people exceed the current recommended guidelines for alcohol consumption in the UK. As well as immediate health effects, drinking too much alcohol has been linked to long term illnesses such as liver diseases (e.g. cirrhosis) and cancers (including breast cancer and bowel cancer). We know that warning labels on cigarettes can increase awareness of the health hazards of smoking, increase beliefs about the risks associated with smoking, decrease cigarette consumption and motivate quit attempts. Therefore, warning labels on alcoholic drinks could also help reduce alcohol consumption and improve the health of the general population but we need to test this before any decisions to use such labels are made. The aim of this study is to estimate the impact on selection of alcoholic drinks displaying image-and-text and text-only HWLs describing adverse health consequences of excessive alcohol consumption.

Who can participate?
Adults over the age of 18, who drink beer or wine at least weekly and shop in a physical supermarket for food and drink regularly (at least monthly).

What does the study involve?
Participants from the research agency's (Blue Yonder Research Ltd) panel of participants will first be contacted by email and invited to complete the initial screening questionnaire and given information on the study. The study is described broadly as an experiment on 'shopping habits and behaviour' to disguise the true aim. If eligible, participants will be randomised to a specific group (image-and-text HWL, text-only HWL or no label) and an appropriate time will be arranged. Participants will be invited to attend a study session and are given information on the study again before providing consent to take part.

Participants will then complete a shopping task in a room set up to look like a real supermarket, with shelves displaying a variety of alcoholic and non-alcoholic drinks and snacks. Participants are asked to do their weekly shop (for drinks and snacks) and are given a shopping trolley to put the selected items in. Depending on their allocated condition the alcoholic drinks will display an image-and-text HWL, text-only HWL or have no labels. Participants leave behind the items they have selected and these items are recorded and returned to the shelves. After the shopping task participants rate both an image-and-text and a text-only HWL presented on a beer or wine bottle on negative emotional arousal to the HWL and acceptability of the HWL. Finally, demographic measures are taken. The study will take approximately 20 minutes to complete. Following completion of the study, participants are asked questions on what they thought the aim of the study was and how 'typical' the shop felt before being debriefed, which includes giving information about the study and the health consequences of consuming excess alcohol.

What are the possible benefits and risks of participating?
Participants will be paid standard market research panel rates for participating in this study. There are no known risks of participating in the study.

Where is the study run from?
Behaviour and Health Research Unit, University of Cambridge (UK) and Blue Yonder Research Limited, Leeds (UK)

When is the study starting and how long is it expected to run for?
August 2019 to February 2020
Data collection will take place over a two week period in February 2020

Who is funding the study?
Wellcome Trust (UK)

Who is the main contact?
Dr Natasha Clarke
ncc42@medschl.cam.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Natasha Clarke

ORCID ID

http://orcid.org/0000-0003-2375-4510

Contact details

Behaviour and Health Research Unit
University of Cambridge
Institute of Public Health Forvie Site
Robinson Way
Cambridge
CB2 0SR
United Kingdom
+44 (0)1223 762565
ncc42@medschl.cam.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Health warning labels and alcohol selection: an experiment in a semi-naturalistic shopping laboratory

Acronym

Study hypothesis

Image-and-text and text-only health warning labels (HWLs) placed on bottles and cans of beer and wine will reduce their selection

Ethics approval

Approved 27/08/19, Cambridge Psychology Research Ethics Committee (School of the Biological Sciences, University of Cambridge, 17 Mill Lane, Cambridge CB2 1RX; +44 (0)1223 766894; Cheryl.Torbett@admin.cam.ac.uk), ref: PRE.2019.058

Study design

Between-subjects randomised experimental study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet.

Condition

Excess alcohol consumption

Intervention

Participants from the research agency's (Blue Yonder Research Ltd) panel of participants will first be contacted by email and invited to complete the initial screening questionnaire and given information on the study. The study is described broadly as an experiment on 'shopping habits and behaviour' to disguise the true aim. If eligible, participants will be randomised to a specific group (image-and-text HWL, text-only HWL or no label) and an appropriate time will be arranged. Participants will be invited to attend a study session and are given information on the study again before providing consent to take part.

Participants will then complete a shopping task in a room set up to look like a real supermarket, with shelves displaying a variety of alcoholic and non-alcoholic drinks and snacks. Participants are asked to do their weekly shop (for drinks and snacks) and are given a shopping trolley to put the selected items in.

Participants will be randomly assigned to one of three groups and requested to select drinks from a range of alcoholic and non-alcoholic drinks, varying in the labels on the alcoholic drinks: Group 1: image-and-text HWL; Group 2: text-only HWL; Group 3: no label (control).

Participants leave behind the items they have selected and these items are recorded and returned to the shelves. After the shopping task participants rate both an image-and-text and a text-only HWL presented on a beer or wine bottle on negative emotional arousal to the HWL and acceptability of the HWL. Finally, demographic measures are taken. The study will take approximately 20 minutes to complete. Following completion of the study, participants are asked questions on what they thought the aim of the study was and how 'typical' the shop felt before being debriefed, which includes giving information about the study and the health consequences of consuming excess alcohol.


Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Proportion of total drinks selected that are alcoholic in the pseudo-purchasing task

Secondary outcome measures

1. Pseudo-purchasing indices:
1.1. Total spend on alcoholic drinks
1.2. Spend on alcoholic drinks as a proportion of total spend
1.3. Number of alcohol units selected: the total number of alcohol units will be calculated from the selected alcohol.
2. Post intervention:
2.1. Negative emotional arousal generated by health warning labels, assessed using a four-item measure, previously used to assess the impact of warning labels on cigarette packages
2.2. Acceptability of health warning labels, assessed using one item, adapted from previous research assessing the impact of sugar tax

Overall trial start date

01/07/2019

Overall trial end date

16/02/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

­1. 18+ years old
­2. Able to read and write in English
­3. Regular drinkers (i.e. consume beer or wine at least once a week)
­4. Purchases supermarket products (food and drink) for household at least monthly
­5. Shops regularly (at least monthly) in a physical supermarket store
­6. Available to attend at least one time slot for each of the study arms (one each for Group 1, Group 2, and Group 3 session). This means that when participants are randomised to one of the arms, it is certain that they will be able to attend at least one time slot for that session.

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

435

Total final enrolment

399

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/02/2020

Recruitment end date

16/02/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Blue Yonder Research Ltd
4325 Park Approach
Leeds
LS15 8GB
United Kingdom

Sponsor information

Organisation

University of Cambridge

Sponsor details

Greenwich House
Madingley Rd
Cambridge
CB3 0TX
United Kingdom
+44 (0)1223333543
Research_Governance@medschl.cam.ac.uk

Sponsor type

University/education

Website

http://www.cam.ac.uk/

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

International organizations

Location

United Kingdom

Results and Publications

Publication and dissemination plan

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

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/08/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/03/2020: The total final enrolment was added. 12/12/2019: Trial’s existence confirmed by University of Cambridge.