Behavior Changing Intervention for Smokeless Tobacco and Betel Quid Use in Adolescents

NCT03488095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2200

Last updated 2019-07-17

No results posted yet for this study

Summary

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

  • Oral Cavity Carcinoma

Interventions

BEHAVIORAL

BCI for SLT and BQ Use in Adolescents: A CRT

BCI for SLT and BQ Use in Adolescents: A CRT is aimed towards changing Adolescenst behaviors regarding their SLT and BQ use to as to reduce Oral cancer Burden within population because of this.

Sponsors & Collaborators

  • Dow University of Health Sciences

    lead OTHER

Principal Investigators

  • Kashif Sahfique, PhD · Dow University of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2016-10-30
Completion
2018-12-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03488095 on ClinicalTrials.gov