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Trial registered on ANZCTR


Registration number
ACTRN12622000318785p
Ethics application status
Submitted, not yet approved
Date submitted
17/12/2021
Date registered
21/02/2022
Date last updated
21/02/2022
Date data sharing statement initially provided
21/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Smoking cessation online program: A randomized controlled trial to test the effectiveness and the feasibility of Facebook platform to reduce smoking among Syrian young adults.
Scientific title
Smoking cessation online programs delivered through Facebook on Syrian university students smokers to test its effects on their motivation and readiness to quit smoking and the feasibility of such an intervention.
Secondary ID [1] 306052 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 324695 0
Condition category
Condition code
Public Health 322145 322145 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A closed Facebook group will be established for Syrian university students smokers for 30 days. This group will be managed by two group moderators coming from medical backgrounds. The first intervention is going to be two posts. The first one is written from open-source resources such as smokefree.gov, the Center for Disease Control website, and other scientific evidence. This post will be in one of the three main following categories: Evidence-based procedure to quit smoking, benefits of quitting smoking, and the harmful effects of smoking. The second post is going to be drafted in a way to encourage discussion among participants themselves and other group members (peers, practitioners, and moderators). Participants will spend 15 minutes per day reading those posts and interacting with them.
This group will also have up to ten peers who are university students and were able to quit smoking previously. The second intervention is the stories of those peers which they will post on that group as either stand-alone posts or by commenting on participants' stories. Plus, the encouragement they will provide the participants with through private messaging. The participants are expected to spend another 15 minutes reading and interacting with those stories and messages.
The last intervention is an optional treatment which is a virtual one-on-one meeting between a participant and a clinical practitioner who had previously trained in smoking cessation procedures to give the participant a personalized consultation. One e-meeting is expected to last up to 15 minutes. A participant is expected to ask for two e-meetings per week, which means the participant will spend up to 30 minutes interacting with the practitioners per week. The virtual one-on-one meetings will last for the entire duration of the online smoking cessation program i.e 30 days.
Intervention code [1] 322455 0
Lifestyle
Comparator / control treatment
There will be a waitlist control group for 30 days. After randomization, this group will not be enrolled in the Facebook group. However, they will answer the same pre- and the post-assessment at the same time as the intervention group, After they answer the post-assessment, they will be enrolled in the Facebook group to receive the same intervention for ethical reasons.
Control group
Active

Outcomes
Primary outcome [1] 329925 0
Smoking cessation outcome by a study-specific tool based on standard smoking cessation outcome by (Piper., et al).
Timepoint [1] 329925 0
Baseline and 30 days after randomization
Primary outcome [2] 329927 0
Readiness to quit smoking by the readiness ruler tool.
Timepoint [2] 329927 0
Baseline and 30 days after randomization
Primary outcome [3] 330095 0
Behavioral intention to quit smoking by the Behavioral intention to quit smoking tool (Landrum Sterling et al., 2007)
Timepoint [3] 330095 0
Baseline and 30 days after randomization
Secondary outcome [1] 404308 0
Participants' motivation to abstain by the motivation to abstain tool
Timepoint [1] 404308 0
Baseline and 30 days after randomization
Secondary outcome [2] 404348 0
Decisional Balance for Smoking to assess change in smoking behavior
Timepoint [2] 404348 0
Baseline and 30 days after randomization
Secondary outcome [3] 404860 0
Feasibility of the smoking cessation program by calculating any costs and auditing study records.
Timepoint [3] 404860 0
after 30 days of randomization
Secondary outcome [4] 404861 0
Fidelity of the intervention by a study-specific tool.
Timepoint [4] 404861 0
after 30 days of randomization

Eligibility
Key inclusion criteria
For participants:
Smoking hookah more than three times per week.
Smoker of more than 3 cigarettes per day.
Vaping more than three times per week
Smoker of both or more of the above who meets one of the above criteria.
University student in a Syrian university
Have a Facebook account.
For peers:
A non-smoker who quit smoking for at least six months.
University student in a Syrian university.
Has a Facebook account.
The criteria for the clinical practitioner:
Medical doctor.
Dentist.
Pharmacist.
Nurse.
Highly interested in smoking prevention.
Preferably have previous community service as a volunteer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation concealment will be undertaken by giving each participant a number and then randomly selecting 60 numbers to be in the intervention group and the other 60 to be in the waitlist control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be first stratified according to their university background, whether they are coming from a public or private university. Another stratification will take place according to the tobacco use of the participants (Cigarettes, hookah, and vaping) Then, the sequence generation will be undertaken using a computerized sequence generation.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
27/03/2022
Actual
Date of last data collection
Anticipated
7/05/2022
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 24451 0
Syrian Arab Republic
State/province [1] 24451 0

Funding & Sponsors
Funding source category [1] 310388 0
Self funded/Unfunded
Name [1] 310388 0
Yazan Kenjrawi
Country [1] 310388 0
Syrian Arab Republic
Primary sponsor type
University
Name
Qasyoun Private University
Address
Daraa highway- Jbab City- Daraa governance.
Country
Syrian Arab Republic
Secondary sponsor category [1] 311553 0
None
Name [1] 311553 0
None
Address [1] 311553 0
None
Country [1] 311553 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310049 0
Qasyoun Private University ethics committee for clinical trials
Ethics committee address [1] 310049 0
Daraa highway- Jbab City- Daraa governance.
Ethics committee country [1] 310049 0
Syrian Arab Republic
Date submitted for ethics approval [1] 310049 0
01/12/2021
Approval date [1] 310049 0
Ethics approval number [1] 310049 0

Summary
Brief summary
Non-communicable diseases (NCDs) are dominating the cause of death out of illness in Syria. Reducing that percentage should start by fighting NCDs risk factors. Smoking is considered one of the top causes of NCDs. With smoking reaching alarming levels among Syrian youth and the lack of smoking cessation programs, the dominance of NCDs is likely to continue. Implementing a smoking cessation program should be driven out of evidence on its effectiveness and its feasibility especially in a low resources environment. Online based-programs adhere to social distancing procedures imposed by the current COVID-19 pandemic. Plus, it has the capability of reaching a highly displaced population. Facebook is the most popular social media among Syrian youth. That’s why this smoking cessation program will rely on Facebook to make use of its popularity. For that purpose, a closed group will be established and run by two coordinators. This group will have a sample of 60 Syrian youth smokers. In addition, it will have up to ten peers who were able to quit smoking previously. The two coordinators will post two posts daily. The first post will be in the following categories: the evidence-based way to quit smoking, the harmful effects of smoking, the beneficial effects of quitting smoking. The second one, however, will be a post to motivate participants and peers to engage with each other’s stories. All members of the group will be encouraged at all times to share their stories, concerns, and challenges. An additional treatment option will be offered for participants to engage in a one-on-one e-meeting with one of the clinical practitioners to receive a personalized consultation. This option will be offered to whoever of the participants who ask for it and for as many times as the participants require.
This study will offer evidence for policymakers on the effectiveness and the feasibility of establishing social support in the future to fight the smoking epidemic. It will also guide future research in terms of other behavioral changes such as alcohol reduction, depression, suicide prevention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116274 0
Dr Yazan Kenjrawi
Address 116274 0
Said's prosthodontics clinic - 01 Squpeen main Street - Squpeen District - Latakia.
Country 116274 0
Syrian Arab Republic
Phone 116274 0
+963948379097
Fax 116274 0
Email 116274 0
[email protected]
Contact person for public queries
Name 116275 0
Yazan Kenjrawi
Address 116275 0
Said's prosthodontics clinic - 01 Squpeen main Street - Squpeen District - Latakia.
Country 116275 0
Syrian Arab Republic
Phone 116275 0
+963948379097
Fax 116275 0
Email 116275 0
[email protected]
Contact person for scientific queries
Name 116276 0
Yazan Kenjrawi
Address 116276 0
Said's prosthodontics clinic - 01 Squpeen main Street - Squpeen District - Latakia.
Country 116276 0
Syrian Arab Republic
Phone 116276 0
+963948379097
Fax 116276 0
Email 116276 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification;
individual participant data underlying published results only.
When will data be available (start and end dates)?
starting from publication date with no end date.
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
To achieve the aims in the approved proposal.
How or where can data be obtained?
By contacting the principal investigator via [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.