Clinical trial · Interventional
Improvement in Knowledge and Perception About Hazards of Smokeless Tobacco
Knowledge and Awareness Regarding Association of Arecanut/Betel Quid and With Oral Cancer and Other Serious Illnesses Among Children 11-16 Years; A Cluster Randomized Intervention Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Oral cancer is a serious and growing problem in many parts of the globe. Oral cancer is the eighth most common cancer worldwide.The annual estimated incidence is around 275,000 for oral and 130,300 for pharyngeal cancers excluding nasopharynx, two-thirds of these cases occurring in developing countries. In Pakistan, it is the second most common cancer in women and third most common cancer in men. The Age Standardized Rates (ASR) for oral cancers are 13.8 and 14.1 in males and females respectively.To the best of investigators knowledge, no intervention study has been done to improve knowledge and awareness of adults regarding association of areca nut/betel quid with oral cancer. Therefore, the study aims to implement a cluster randomized intervention trial in secondary schools to improve the knowledge and awareness regarding this association among children 11-16 years. For resource poor countries such as Pakistan, it is imperative to prevent oral cancer by improving knowledge about its important risk factor such as betel quid, areca nut and chew tobacco. A school-based intervention study will be carried out in secondary schools in Karachi. The target population will be male and female school students in school grades 6 to 10 with intervention group and control group at each site. School-based educational intervention will be given to the intervention group while no specific education will be given to the control group. Differences in attitudes, knowledge and behaviors between the intervention and control groups will be compared each site separately before and after the intervention. The minimum sample size required was 22 schools (clusters). The number of subjects in each arm will be 529 with average cluster size of 50. The selected schools will be randomly assigned to a control group or Interventions group. Randomization will be done at the school level to avoid contamination between groups.The health education programme will be conducted for 3 consecutive weeks in one academic year for all the selected schools.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Smokeless Tobacco Cessation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SMOKELESS TOBACCO AWARENESS PROGRAM | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- A SMOKELESS TOBACCO AWARENESS PROGRAM was conducted for 2 consecutive weeks in all the selected schools. The intervention programme comprised of health education sessions that emphasized on the hazard of betel quid, areca-nut and smokeless tobacco. The sessions included 30 minutes power point presentation, posters, one pictorial booklets on the hazards of use of various tobacco products. Moreover we played a 30 minutes game show at follow-up visit. After completion of 2 weeks intervention programme, the same group of students completed the post-test questionnaire. Educational materials about hazards of betel quid, areca-nut and smokeless tobacco were distributed to both intervention and control groups.
- interventionNames
- Behavioral: SMOKELESS TOBACCO AWARENESS PROGRAM
- type
- NO_INTERVENTION
- label
- Control
- description
- No specific education will be given to the control group.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 11 Years
- Maximum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Inclusion criteria for cluster/school * High schools registered with Board of Secondary Education Karachi * The schools should have at least 15 students in each grade. * School authorities grant permission to conduct the research study in their school. Inclusion criteria (For individual) * Both Male/ female students from grades 6-10. * Resident of selected areas where the schools are located for at least one year. Exclusion Criteria: \-
References
Publications (1)
- DERIVEDRozi S, Zahid N, Roome T, Lakhdir MPA, Sawani S, Razzak A, Butt ZA. Effectiveness of a School Based Smokeless Tobacco Intervention: A Cluster Randomized Trial. J Community Health. 2019 Dec;44(6):1098-1110. doi: 10.1007/s10900-019-00689-8. PMID 31267293