Behavior change intervention design to control vaping and tobacco use in secondary students in As Seeb
| ISRCTN | ISRCTN44491995 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44491995 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Ministry of Health |
| Funder | Oman Ministry of Health |
- Submission date
- 04/04/2025
- Registration date
- 22/04/2025
- Last edited
- 22/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This research project aims to understand how many grade 11 students in Muscat, Oman, use tobacco and vape, and what factors influence these behaviors. It also aims to test a school-based program designed to help students quit smoking.
Who can participate?
Grade 11 students from schools in A Seeb area of Muscat can participate in the first part of the study. Students identified as smokers from the first part will be invited to participate in the second part.
What does the study involve?
In the first part, students will take part in face-to-face interviews conducted by school health nurses using a survey from the World Health Organization. In the second part, students who smoke will receive monthly counseling sessions for four months to help them quit smoking.
What are the possible benefits and risks of participating? Participants may benefit from gaining a better understanding of their smoking habits and receiving support to quit smoking. There are minimal risks involved, mainly related to the time commitment for the interviews and counseling sessions.
Where is the study run from?
Ministry of Health, Oman
When is the study starting and how long is it expected to run for?
March 2025 to September 2027
Who is funding the study?
Ministry of Health, Oman
Who is the main contact?
Dr Thamra Alghafri, thamra74@yahoo.com
Contact information
Public, Scientific, Principal investigator
P O box 113
Muscat
113
Oman
 ORCID ID |
0000-0002-4818-9565 |
|---|---|
| Phone | +968-99376455 |
| t.alghafri@squ.edu.om |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional non randomized |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Behavior change intervention design to control vaping and tobacco use in secondary students in As Seeb area: a pre-post intervention study |
| Study objectives | Is Motivational Interviewing counselling effective in helping high school students to quit tobacco use including vaping? |
| Ethics approval(s) |
Submitted 12/03/2025, Research Ethics Committee in Sultan Qaboos University (The Dean's Office P.o. Box 20; Al Khodh Postal Code 123, Muscat, 123, Oman; +968 2443407; t.alghafri@squ.edu.om), ref: - |
| Health condition(s) or problem(s) studied | Motivational Interviewing counselling for smoking cessation |
| Intervention | For study 1: a cross-sectional study in which structured face-to-face interview (survey) will be conducted by trained school health nurses utilizing the World Health Organization (WHO) Global Youth Tobacco Survey (GYTS) questionnaire, including data on the demographics, behavioral intentions, attitudes, subjective norms and perceived behavioral control on smoking (constructs of the Theory of Planned Behavior - TPB). A representative sample (n=886) from all schools of A Seeb area in Muscat, the capital of Oman, will be included (12 x schools). Logistic regression models will be done to determine factors associated with tobacco use and change in the constructs of the TPB. A team from the Ministry of Health and Education will be trained on project objectives, measurement tools, recruitment procedures, and data collection. For study 2, a pilot quasi-experimental single arm pre- and post-study will be used (n=28, students identified as smokers from study 1). School health nurses (n=12) will be trained to deliver the behavior change intervention monthly for 4 months. School nurses will deliver monthly school-based interventions to the students over 4 months. The monthly intervention is composed of a 30-40 minutes counselling session guided by Motivational Interviewing (MI) strategies widely used for adolescent smoking cessation. Motivational interviewing (MI) is a brief, client-centered approach focused on resolving doubts regarding quitting and increasing self-efficacy for change. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Tobacco use behaviour will be assessed using GYTS WHO constructs before and after the intervention. |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 01/09/2027 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Child |
| Lower age limit | 15 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 886 |
| Key inclusion criteria | A sample of grade 11 students in 13 secondary schools in A Seeb area in Muscat region will be included. All students willing to participate in an interview based one to one interview will be included. |
| Key exclusion criteria | Not willing to participate |
| Date of first enrolment | 01/10/2025 |
| Date of final enrolment | 28/10/2025 |
Locations
Countries of recruitment
- Oman
Study participating centre
Muscat
123
Oman
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Anonymized individual participant data can be made available upon request to the Principal Investigator, subject to approvals from the Ministry of Education and the Ministry of Health thamra74@yahoo.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
22/04/2025: Trial's existence confirmed by Sultanate of Oman Ministry of Health.
