Clinical trial · Interventional
Behavior Changing Intervention for Smokeless Tobacco and Betel Quid Use in Adolescents
Behavior Changing Intervention for Smokeless Tobacco and Betel Quid Use in Adolescents: A Cluster-Randomized Trial
- 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)
Smokeless tobacco (SLT) is a known risk factor for Oral, Pharyngeal and Esophageal carcinoma. Three-quarters global SLT consumption is among the South Asian Population. The habit of SLT chewing commences at a very young age which has an underpinning of socio-cultural dimension in South Asian population which perhaps due to its more addictive potential, has more dependency. Youth also perceives SLT as a part of confectionery, which is socially served in South Asian ceremonies. There exists very little or no evidence regarding efficacy of SLT cessation interventions in this population. Most of the existing interventions are based in western world with little or no cultural sensitivities pertinent to South Asia. In this study, a culturally rooted behavior changing intervention (BCI) to alter SLT use prevalence, perceptions pertinent to the deleterious effects of SLT use in the etiology of oral cancers and help youth quit SLT in Karachi, Pakistan. Baseline demography and SLT use prevalence will be ascertained among 11-16-year-old school going children from both government and private schools. Multi stage cluster sampling will randomly recruit forty clusters (schools) from within 6 districts of Karachi, which will then be divided into intervention and control groups (clusters) using block randomization based on proportionate number of each school type present (Government and Private). Both groups' participants will complete all questionnaires pre and post intervention as described elsewhere and will also undergo screening for oral cancer and oral potentially malignant lesions (OPMLs). Students in intervention cluster will be given BCI and printed pamphlets along with a gift pack (reminder for SLT quit, a branded tooth paste and a tooth brush) while students in control cluster will only differ in that they will not be exposed to BCI. BCI was designed after reviewing literature and consulting specialist group for all untoward effects of SLT use in Oral Cavity that have a potential of transforming into oral carcinoma. A follow up after 12 weeks will be conducted to re-assess their SLT use prevalence, perceptions regarding hazardous effects of SLT use in oral cavity, dependency on SLT and success in quit (among users in both groups), and perception regarding warning labels on SLT product packet
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 |
|---|---|---|---|
| Oral Cavity Carcinoma | Oral Cavity Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCI for SLT and BQ Use in Adolescents: A CRT | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Behavior changing intervention
- description
- Thirty minutes behavior counselling (PPT.) to experimental group. BCI for SLT and BQ Use in Adolescents: A CRT
- interventionNames
- Behavioral: BCI for SLT and BQ Use in Adolescents: A CRT
- type
- NO_INTERVENTION
- label
- Control Cluster
- description
- No thirty minutes behavior counselling (PPT.) to control group
Primary outcomes (1)
- measure
- Changing perceptions regarding SLT and BQ use
- timeFrame
- 3 months
- description
- modified Global Youth Tobacco Survey will be used to assess the perceptions of adolescents
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 11 Years
- Maximum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: • 11-16 years school going children with NO diagnosed oral cancer Exclusion Criteria: * Students younger or older than mentioned ages * Diagnosed Oral Cancer patients
References
Publications (1)
- DERIVEDHussain A, Zaheer S, Shafique K. School-based behavioral intervention to reduce the habit of smokeless tobacco and betel quid use in high-risk youth in Karachi: A randomized controlled trial. PLoS One. 2018 Nov 2;13(11):e0206919. doi: 10.1371/journal.pone.0206919. eCollection 2018. PMID 30388182