NCT06483763

Brief Summary

Tobacco use is a leading cause of preventable morbidity and mortality worldwide. It has been estimated that by 2030, tobacco use will cause approximately 10 million deaths per year worldwide, with 70% of those occurring in low- and middle-income countries. Oman, a country in the Arabian Peninsula, is not immune to this global health problem. Tobacco use is prevalent among young people in Oman, and efforts to prevent and control tobacco use among youth are a public health priority. This study employs a cluster randomized controlled trial design to assess the impact of a photo-gaining app versus a structured educational intervention on tobacco knowledge and attitudes among adolescents in Sohar, Oman. Boys' public schools serve as clusters, with students in grades 9 to 12 as participants. Schools are randomly assigned to either an intervention or control group. The intervention, facilitated by medical students trained at a local university, involves using the SmokerFace App to demonstrate the effects of smoking via photo-aging technology. The control group receives a standardized educational module endorsed by the World Health Organization. Primary outcomes focus on comparing tobacco knowledge levels between groups, while secondary outcomes examine attitudes towards tobacco use. Pre-intervention and post-intervention assessments are conducted using the modified WHO Global Youth Tobacco Survey. Randomization is implemented in two stages to ensure balance, and efforts are made to maintain blinding among outcome assessors and data analysts. The proposed study is a cluster randomized trial aimed at evaluating the impact of a photo-aging app versus structured educational intervention on knowledge and attitude towards tobacco use and tobacco consumption habits among Omani adolescents. The results of this study will be important for developing effective strategies for preventing tobacco use among youth in Oman and other countries with similar socio-cultural contexts.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

June 26, 2024

Last Update Submit

July 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The difference in the level of knowledge regarding the harmful effects of tobacco use between the intervention and control groups using the GYTS Scale

    12 Weeks

Secondary Outcomes (1)

  • The difference in the attitudes towards tobacco use between the intervention and control groups using the GYTS Scale

    12 weeks

Study Arms (2)

The group using the SmokerFace App from the Education Against Tobacco (EAT) program

OTHER

Trained medical students will deliver the intervention and will be conducted in the specific classrooms of enrolled schools. The school students will be taught how to use the SmokerFace App from the Education Against Tobacco (EAT) program (26) with parental supervision at home. Medical Students will send the links to download the app from the App Store (iOS) and Play Store (Android), along with an explanation of how to install and use the app.

Other: SmokerFace App from the Education Against Tobacco (EAT) program

The group receiving of standardized school-based educational module

OTHER

The control arm will receive a standardized school-based educational module that aligns with the tobacco health hazards awareness educational toolkit provided by the World Health Organization.

Other: The use of standardized school-based educational module

Interventions

The SmokerFace App utilizes photo-aging technology that requires users to take a selfie. This selfie is processed by the software to generate four images depicting the consequences of smoking (or not smoking) one pack a day over both a one-year and 15 years. The app provides explanations of these smoking beauty-reducing visual outcomes and educates users about the aesthetic impacts of smoking, along with potential health consequences.

The group using the SmokerFace App from the Education Against Tobacco (EAT) program

This module is designed to promote a tobacco- and nicotine-free environment and is validated by at least three experts in related fields (27). The intervention will be customized to fit the Omani sociocultural context and will be administered in the classrooms of respective schools by the same team of trained medical students

The group receiving of standardized school-based educational module

Eligibility Criteria

Age15 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Inclusion and Exclusions Criteria: All Boys' public schools in Sohar, North Al-Batinah Region, from classes 9 to 12, were included in the study. Girls' schools as well as parents and students who declined participation were excluded from the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National University of Science and Technology

Sohar, Oman

Location

Related Publications (1)

  • Al-Mahrouqi T, Al-Ghailani F, Al-Maqbali M, Al Saidi M, Prashanth GP. A cluster randomized trial comparing photoaging app and school based educational intervention for tobacco use prevention in adolescents. Sci Rep. 2025 May 2;15(1):15374. doi: 10.1038/s41598-025-00165-5.

MeSH Terms

Conditions

Tobacco Use CessationSmoking Cessation

Interventions

Eating

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

February 1, 2024

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

July 8, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations