Condition category
Mental and Behavioural Disorders
Date applied
29/04/2015
Date assigned
29/04/2015
Last edited
07/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The availability and use of electronic (“e”) cigarettes has risen rapidly in the last three years with an estimated 2.1 million people using e-cigarettes in the UK in 2014 and 15.7 million in the USA in 2013. E-cigarettes have the potential to be both beneficial and harmful. The main potential benefit is that they may help current smokers to stop using tobacco cigarettes. The main potential harm is that they may encourage children to start using tobacco cigarettes through the presentation of glamorous images associated with objects that resemble cigarettes. In this study, we look at whether exposing children to adverts depicting e-cigarettes as glamorous increases the appeal of tobacco smoking, appeal being a predictor of subsequent tobacco use. We also look at whether exposing participants to adverts emphasizing the potential health benefits of e-cigarettes reduces the appeal of tobacco smoking.

Who can participate?
Young people aged 11-16 from the UK.

What does the study involve?
Participants are randomly allocated to one of three groups. Those in group one are shown a series of pictures associating e-cigarettes with glamour. Those in group two are shown a series of pictures associating e-cigarettes with potential health benefits and an aid to stop smoking tobacco cigarettes. Those in group 3 are not shown any pictures (control group). All participates are asked to fill in a questionnaire and are asked some questions on their responses to the advertisements and how appealing they find tobacco and e-cigarettes. They also answer some questions about their own experiences with e-cigarettes and tobacco cigarettes.

What are possible benefits and risks of participating?
The public health community has raised concerns that e-cigarette adverts might influence how appealing children find tobacco, but currently evidence is lacking. The present study will contribute to a better understanding of how children perceive e-cigarette adverts and whether and how these adverts might influence the appeal of tobacco smoking in children. The present study will contribute to evidence that can form the basis for policy aimed at protecting children. We do not envisage the study will result in any anxiety or discomfort.

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

Where is the study run from?
The Behaviour and Health Research Unit at the University of Cambridge in collaboration with ICM Direct.

Who is funding the study?
Department of Health Policy Research Programme (Policy Research Unit in Behaviour and Health [PR-UN-0409-10109]) (UK)

Who is the main contact?
Professor Theresa Marteau

Trial website

Contact information

Type

Scientific

Primary contact

Professor Theresa Marteau

ORCID ID

Contact details

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

Exposure to e-cigarette adverts and the appeal of tobacco smoking in children: an experimental study

Acronym

Study hypothesis

There is growing concern about the marketing of e-cigarettes and in particular the potential for this to attract young children not just to e-cigarettes but also to tobacco smoking. Some e-cigarette adverts emphasise the glamorous aspects of using these products, and others emphasise their health benefits. Our primary hypothesis is that exposure of children to e-cigarette adverts that emphasise glamour increases the appeal of tobacco. Our secondary hypothesis is that exposure to adverts emphasizing the potential health benefits of e-cigarettes reduces the appeal of tobacco smoking.

Ethics approval

Cambridge Psychology Research Ethics Committee, 11/12/2014, ref: 014.103

Study design

A between-subjects experimental design in which participants are randomised to one of three groups differing in the exposure to e-cigarette adverts.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Other

Patient information sheet

Condition

Tobacco smoking, which causes cancer, chronic obstructive pulmonary disease, stroke and heart disease.

Intervention

Exposure to e-cigarette adverts in two of three groups:
1. Exposure to adverts associating e-cigarettes with glamour (e.g., attractive design, socially appealing, high tech)
2. Exposure to adverts associating e-cigarettes with function (e.g., health claims, aid to smoking cessation)
3. Exposure to no adverts (control)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The primary outcome is appeal towards smoking tobacco cigarettes

Secondary outcome measures

1. Attitudes towards tobacco smoking
2. Susceptibility to tobacco smoking
3. Estimates of smoking rates among young people
4. Appeal of e-cigarettes
5. Attitudes towards e-cigarettes adverts

Overall trial start date

01/05/2015

Overall trial end date

15/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

The following inclusion criteria are applied:
1. Age: 11-16 years old
2. Gender: Both male and female participants are recruited
3. Location: Participants across the UK are recruited. However, only participants in selected sampling units (Super Output Areas; SOA) can participate, as per our sampling procedure

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

572 participants will be recruited to the study. 429 participants provide 90% power at p = .01 to detect a medium-size difference (d = .46) between the “glamour” condition and the control condition, and a similar sized difference (but in the opposite direction) between the “function" condition and the control condition. Given we plan to investigate the effects of e-cigarette marketing on those who have never smoked, we have overpowered the study by 25%, to accommodate the removal of the estimated proportion of children who have smoked cigarettes (22%; HSCIC, 2014) or e-cigarettes (10%, 90% of whom are smokers; HSCIC, 2014).

Participant exclusion criteria

1. Age: participants aged younger than 11 or older than 16 years old
2. Location: Participants outside the selected UK SOAs

Recruitment start date

01/05/2015

Recruitment end date

13/06/2015

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to submit the main results of this study for publication in a high-impact factor journal by 15/12/2015. We will disseminate the results to the public, policy makers and other researchers through targeted social media.

Intention to publish date

15/12/2015

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes