Comparing the effect of pictorial warnings on tobacco products in Saudi Arabia with other international pictorial warnings

ISRCTN	ISRCTN15420143
DOI	https://doi.org/10.1186/ISRCTN15420143
Secondary identifying numbers	U1111-1180-7781

Submission date: 20/03/2016
Registration date: 22/03/2016
Last edited: 21/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Nasser F BinDhim
Scientific

Saudi Electronic University
Abu Bakr Street
Riyadh
11673
Saudi Arabia

ORCID ID	0000-0001-8117-1044
Phone	+966 11 2613500
Email	n.dhim@seu.edu.sa

Study information

Study design	Online double-blind randomized parallel trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Internet/virtual
Study type	Prevention
Participant information sheet	http://shproject.net/PIS-EPWI-RCT.docx
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
Study acronym	EPWI
Study objectives	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(s)	King Saud University Research Ethics Committee, 05/10/2015, ref: 4/2015
Health condition(s) or problem(s) studied	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
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 study start date	20/09/2015
Completion date	01/05/2017

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	1554
Key inclusion criteria	1. Aged 18 years and over 2. Residents of Saudi Arabia 3. Arabic language speakers
Key exclusion criteria	1. Aged under 18 years 2. Non-Saudi residents 3. Non-Arabic language speakers
Date of first enrolment	01/05/2016
Date of final enrolment	01/08/2016

Locations

Countries of recruitment

Saudi Arabia

Study participating centres

King Saud University

P. O. BOX 2454
Riyadh
12372
Saudi Arabia

Saudi Electronic University

Saudi Arabia - Riyadh - Abu Bakr Street
Riyadh
11673
Saudi Arabia

Sponsor information

Saudi Electronic University
University/education

Abu Bakr Street
Riyadh
11673
Saudi Arabia

Phone	+966 11 2613500
Email	contact@seu.edu.sa
Website	https://www.seu.edu.sa
"ROR"	https://ror.org/05ndh7v49

Funders

Funder type

University/education

Deanship of Scientific Research at Saudi Electronic University

No information available

Results and Publications

Intention to publish date	01/10/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.
IPD sharing plan