Plain English Summary
Background and study aims
Cigarette smoking is highly addictive and is one of the biggest causes of illness and death worldwide. The best way to reduce the amount of tobacco-related deaths is by encouraging people to quit smoking or not to start in the first place. Governments in different countries have used a range of strategies to reduce smoking such as increasing tax on cigarettes, banning smoking in public places and the use of pictures showing the damaging effects of smoking (pictorial warnings) on tobacco products. In Gulf Cooperation Council (GCC) counties, including Saudi Arabia, the use of pictorial warnings is readily enforced. The aim of this study is to find out how people in Saudi Arabia respond to these warnings and which pictures are the most emotionally provoking and best at encouraging people to quit smoking.
Who can participate?
Adults who live in Saudi Arabia and speak Arabic.
What does the study involve?
Participants are randomly allocated to one of three groups. Each group views a set of three pictorial warnings (from the GCC, UK or Australia), and are asked to read the accompanying information about what the warnings are about. After this, participants are asked to rate the warnings in order of emotional impact. Before seeing the pictures, immediately after seeing the pictures and again two weeks later, participants complete a survey in order to assess their knowledge about the harmful effects of smoking and their attitudes towards smoking. After two weeks, participants in all groups are also asked to complete a short, five minute survey in order to find out how well they remember the pictorial warnings and if they have quit smoking (if they are a smoker).
What are the possible benefits and risks of participating?
Participants will benefit from learning more about the effects of smoking on health. There are no notable risks involved with taking part in this study.
Where is the study run from?
The study is run from King Saud University and Saudi Electronic University (Saudi Arabia) and takes place online.
When is the study starting and how long is it expected to run for?
September 2015 to May 2017
Who is funding the study?
Deanship of Scientific Research at Saudi Electronic University (Saudi Arabia)
Who is the main contact?
Dr Nasser F BinDhim
n.dhim@seu.edu.sa
Trial website
Contact information
Type
Scientific
Primary contact
Dr Nasser F BinDhim
ORCID ID
http://orcid.org/0000-0001-8117-1044
Contact details
Saudi Electronic University
Abu Bakr Street
Riyadh
11673
Saudi Arabia
+966 11 2613500
n.dhim@seu.edu.sa
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
U1111-1180-7781
Study information
Scientific title
Evaluating the impact of Pictorial Warnings on tobacco products in Saudi Arabia against other International pictorial warnings: An online double-blind randomised parallel trial
Acronym
EPWI
Study hypothesis
The aim of this study is to evaluate the impact of pictorial warnings on tobacco products in Saudi Arabia against selected international pictorial warnings.
Null hypothesis:
There are no differences between pictorial warnings implemented in Saudi Arabia and those implemented in other countries in terms of the stimulating quit attempts, improving knowledge about smoking, changing attitude about smoking, and initiate negative emotional effect about smoking.
Ethics approval
King Saud University Research Ethics Committee, 05/10/2015, ref: 4/2015
Study design
Online double-blind randomized parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Internet
Trial type
Prevention
Patient information sheet
http://shproject.net/PIS-EPWI-RCT.docx
Condition
Cigarette smoking
Intervention
Participants are randomly allocated to one of three groups automatically by the study website, which also stratifies for age, gender and smoking status.
Group 1: Participants are shown a set of three pictorial warnings originating from GCC and to read the associated information. They are asked to rate the warnings in order of emotional impact.
Group 2: Participants are shown a set of three pictorial warnings originating from Australia and to read the associated information. They are asked to rate the warnings in order of emotional impact.
Group 3: Participants are shown a set of three pictorial warnings originating from the UK and to read the associated information. They are asked to rate the warnings in order of emotional impact.
After 2 weeks, all participants are asked to complete a follow up questionnaire including questions about recent quit attempts, knowledge about smoking, attitude about smoking, and recalling the pictorial warnings seen in the randomization group. The follow up process will take approximately 5 minutes.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Self-rated impact and emotional responses to the pictorial warnings is measured using the valence and arousal scales of the Self-Assessment Manikin and the Brief Worry Scale about Smoking directly after the intervention.
Secondary outcome measures
1. Knowledge about smoking health related outcomes are measured using a participant survey designed for this study at baseline, directly after the intervention and 14 days after the intervention
2. Attitude toward smoking is measured using a participant survey designed for this study at baseline, directly after the intervention and 14 days after the intervention
3. Smoking behavior for smokers including quitting attempts are measured using a participant survey designed for this study at 14 days after the intervention
4. Recall of the pictorial warnings are measured using a participant survey designed for this study at 14 days after the intervention
Overall trial start date
20/09/2015
Overall trial end date
01/05/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years and over
2. Residents of Saudi Arabia
3. Arabic language speakers
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
1554
Participant exclusion criteria
1. Aged under 18 years
2. Non-Saudi residents
3. Non-Arabic language speakers
Recruitment start date
01/05/2016
Recruitment end date
01/08/2016
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
King Saud University
P. O. BOX 2454
Riyadh
12372
Saudi Arabia
Trial participating centre
Saudi Electronic University
Saudi Arabia - Riyadh - Abu Bakr Street
Riyadh
11673
Saudi Arabia
Sponsor information
Organisation
Saudi Electronic University
Sponsor details
Abu Bakr Street
Riyadh
11673
Saudi Arabia
+966 11 2613500
contact@seu.edu.sa
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Deanship of Scientific Research at Saudi Electronic University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results of the trial will be published in peer-reviewed journals according to the Consolidated Standards of Reporting Trials (CONSORT) statement.
Intention to publish date
01/10/2017
Participant level data
Available on request
Basic results (scientific)
Publication list