Condition category
Not Applicable
Date applied
17/10/2018
Date assigned
23/10/2018
Last edited
15/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
Article 20 of the EU Tobacco Products Directive (EU-TPD) states that e-cigarette packets and refill products must carry a health warning of either ‘This product contains nicotine which is a highly addictive substance’, or ‘This product contains nicotine which is a highly addictive substance. It is not recommended for use by non-smokers’.
Given the reduced risks associated with e-cigarettes, UK health and policy makers recommend that smokers who are unwilling or unable to quit should be encouraged to switch to e-cigarettes. However, in recent years, public misperceptions of harm associated with e-cigarettes use have increased, with only 13% of survey respondents in the UK correctly believing that e-cigarettes are considerably less harmful than tobacco smoking.
The purpose of this online experiment is to investigate the potential effects of the EU-TPD health warning labels on e-cigarette products versus a newly generated comparative health message statement on smokers’ and non-smokers’ perceptions of harm and intentions to use e-cigarettes. Additional aims of this study are to measure the effects on smokers' intentions to quit and use e-cigarettes in quit attempts. Lastly, the potential benefits of providing a comparative harm message either in addition to the TPD warning or as a stand-alone message will be explored.

Who can participate?
Adults in the UK who are not current e-cigarette users or ex-smokers

What does the study involves?
This is an online experiment and should take approximately 10 minutes to complete.
After reading the study information and agreeing to take part, participants will be asked to provide some information about themselves and their smoking habits and e-cigarettes use. They will then be asked some questions about how harmful, addictive and acceptable e-cigarettes are and their intentions to use them in the future. This will be followed by viewing several e-cigarette package images which may include either written statements warning about nicotine addictiveness, written statements about health or no written statements at all. Participants will then be asked questions about the images, the written messages and some more questions about their perceptions of e-cigarettes and intentions to use. Finally, participants will be presented with an on-screen debriefing letter explaining the full aims of the study and providing NHS links with useful advice on ways to quit and supporting materials including further information about e-cigarettes.

What are the possible benefits and risks of participating?
Participants will be awarded with points, which they will receive after completing the survey. The number of points can be redeemed in cash or vouchers (i.e. Amazon). Respondents can redeem their cash after cumulating 150 points or more (equating to £15).
The panel recruitment agency MRFGR, a Division of AGENTC Ltd will be responsible for the recruitment and payment of participants. Participants are awarded with points which they receive after completing the survey.
There are no known risks to participants taking part in this study. However, it is possible that the exposure of the images of e-cigarettes may induce an interest in non-smokers/never e-cigarette users to use an e-cigarette. To mitigate against this risk, participants will be fully debriefed about the relative risks of e-cigarettes and warned that these products are not recommended for non-smokers.

Where is the study run from?
London South Bank University (UK)

When is the study starting and how long is it being run for?

Who is funding the study?
Cancer Research UK (UK)

Who is the main contact:
1. Catherine Kimber (kimberc3@lsbu.ac.uk)
2. Dr Lynne Dawkins (dawkinl3@lsbu.ac.uk)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lynne Dawkins

ORCID ID

http://orcid.org/0000-0003-1236-009X

Contact details

Centre for Addictive Behaviours Research
Division of Psychology
School of Applied Sciences
103 Borough road
London South Bank University
London
SE1 0AA
United Kingdom
+44 (0)20 7815 5422
dawkinl3@lsbu.ac.uk

Type

Public

Additional contact

Mrs Catherine Kimber

ORCID ID

http://orcid.org/0000-0001-9994-8640

Contact details

Centre for Addictive Behaviours Research
Division of Psychology
School of Applied Sciences
103 Borough road
London South Bank University
London
SE1 0AA
United Kingdom
+44 (0) 207 815 5447
kimberc3@lsbu.ac.uk

Type

Scientific

Additional contact

Dr Daniel Frings

ORCID ID

http://orcid.org/0000-0002-0183-9516

Contact details

Centre for Addictive Behaviours Research
Division of Psychology
School of Applied Sciences
103 Borough road
London South Bank University
London
SE1 0AA
United Kingdom
+44 (0)20 7815 5888
fringsd@lsbu.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CRUK Grant Number: 25855; Open Science Framework: osf.io/ta4vx

Study information

Scientific title

The effects of the European e-cigarette health warnings and comparative health messages on non-smokers' and smokers' risk perceptions and behavioural intentions

Acronym

Study hypothesis

This Cancer Research UK (CRUK) funded study will investigate the effects of the TPD e-cigarette health warnings and a comparative harm message on smokers’ and non-smokers’ perceptions of harm, addictiveness and social acceptability of e-cigarettes. Additional aims are to evidence the potential effects of the TPD warnings, as they are implemented, on smokers’ intentions to purchase and use e-cigarettes in future quit attempts. Lastly, the potential benefits of providing a comparative harm message either in addition to the TPD warning or as a stand-alone message will be explored.

Hypothesis 1:
Participants exposed to the TPD health warning will rate e-cigarettes as more harmful and addictive compared to those exposed to the TPD warning combined with a comparative message (TPD+) the comparative health message (COMP) alone and the no message control condition

Hypothesis 2:
For participants exposed to the TPD health warnings, post-exposure scores on intentions to purchase and use e-cigarettes will decrease compared to those exposed to the COMP alone, the TPD+ messages, or no message (control)

Hypothesis 3:
TPD health warnings will decrease quit intentions in smokers and the comparative health message (COMP and TPD+ conditions) will attenuate this effect

For hypotheses 1 and 2 we will explore differences between smokers and non-smokers.

Ethics approval

London South Bank University Ethics Committee, 04/07/2018, reference SAS1815

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Smoking-related behaviours

Intervention

Block randomisation will be used for allocation of conditions and demographic variables (including smoking status) will be stratified so that the sample of smokers is representative of the target population in line with ONS data. Each participant will be assigned to one of the six conditions to obtain equal group sizes using IBM SPSS. Participants will be exposed to one of six stimuli displayed on screen for a standardised period of 30 seconds. Message statements will be displayed on e-cigarette package images as per the current EU-TPD warning labels on e-cigarette products. Warning label stimuli are:
1. TPD1: TPD health warning as per currently implemented in the UK. “This product contains nicotine which is a highly addictive substance"
2. TPD2: TPD longer health warning as currently implemented in many EU countries: "This product contains nicotine which is a highly addictive substance. It is not recommended for non-smokers"
3. COMP: Comparative health message as generated in the pilot study (using the same parameters used for the TPD warning labels; font, font colour, size and placement on the pack)
4. TPD1+: The TPD health warning (TPD1) in combination with the comparative message (using the same parameters above)
5. TPD2+: The TPD longer health warning (TPD2) in combination with the comparative message (using the same parameters as above).
6. No message: A no message condition using the same e-cigarette packages
There will be no follow-up period and the study experiment will take approximately 10 minutes.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Smokers’ and non-smokers’ perceptions of e-cigarettes associated with:
1. Harm
2. Addictiveness
3. Social acceptability
4. Effectiveness
5. Intention to purchase
6. Intention to use e-cigarettes
This will be assessed at the baseline and at the end of the intervention (after exposure to messages) using a 7-point Likert rating scale with the anchors "Extremely" to "Not at all"

Secondary outcome measures

N/A

Overall trial start date

01/04/2018

Overall trial end date

31/01/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 or over
2. Resident in the UK
3. Fluent in English

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

2400 participants will be recruited (1200 smokers and 1200 non-smokers)

Total final enrolment

2495

Participant exclusion criteria

1. Current e-cigarette users (including dual users, those who smoke tobacco cigarettes and use e-cigarettes)
2. Former smokers

Recruitment start date

12/11/2018

Recruitment end date

31/01/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Addictive Behaviours Research, London South Bank University
Division of Psychology School of Applied Sciences 103 Borough road London South Bank University
London
SE1 0AA
United Kingdom

Sponsor information

Organisation

London South Bank University

Sponsor details

Centre for Addictive Behaviours Research
Division of Psychology
School of Applied Sciences
Room E329; 103 Borough road
London South Bank University
London
SE1 0AA
United Kingdom
+44 (0) 20 7815 6100
supporter.services@cancer.org.uk

Sponsor type

University/education

Website

https://www.lsbu.ac.uk/

Funders

Funder type

Not defined

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Results and Publications

Publication and dissemination plan

We will disseminate a lay summary, explaining our findings and their importance. The findings will be disseminated via open access peer-review publication, conference presentations and press releases, and shared with a number of charities, practitioners and public health and policy organisations via presentations, briefing papers and web-based material. We expect the dissemination of the data to occur some time around end of March, beginning of April.

IPD sharing statement:
The study will use a panel agency that is GDPR (General Data Protection Regulations) compliant. All data will be kept in accordance with the study protocol and with GDPR’s requirements under password protected networked PCs and any documents on hard copies in locked filing cabinets in a locked office. Once finalised, anonymised data will be deposited on the University’s open data repository. The data collected are intended to benefit the general public and to inform policy decision making; we will therefore preserve all data resulting from the study (with the exception of personal data) and make it publically available with as few restrictions as possible. The data will be given a CC-BY license which will require any future users to acknowledge the investigators in any subsequent publications arising from use of the data

Intention to publish date

31/01/2021

Participant level data

Stored in repository

Basic results (scientific)

Publication list

1. 2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30428933
2. 2020 results in: https://www.ncbi.nlm.nih.gov/pubmed/31753541(added 13/01/2020)

Publication citations

Additional files

Editorial Notes

15/07/2020: The overall end date was changed from 01/06/2020 to 31/01/2019. 13/01/2020: The following changes have been made: 1. Publication reference added. 2. The total final enrolment number has been added from the reference. 10/01/2020: The following changes have been made: 1. The overall trial end date has been changed from 31/01/2019 to 01/06/2020. 2. The intention to publish date has been changed from 21/11/2019 to 31/01/2021. 09/01/2019: The following changes have been made: 1. The recruitment end date has been updated from 31/12/2018 to 31/01/2019. 2. The overall trial end date has been updated from 21/01/2019 to 31/01/2019. 16/11/2018: Publication reference added.