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

NCT03488095 | Completed

• 1 other identifier: DUHS/DR-O/2016/116
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tobacco, smokeless, chewing, betel quid

Outcome Measures

Primary Outcomes (1)

• Changing perceptions regarding SLT and BQ use

  modified Global Youth Tobacco Survey will be used to assess the perceptions of adolescents

  3 months

Secondary Outcomes (4)

• prevalence of SLT and BQ use in 11-16-year-old

  3 months

• Quit/quit attempts by the participants

  three months

• prevalence of OPMLs in the users of SLT and BQ

  three months

• perceptions regarding warning labels on SLT and BQ product pack

  three months

Study Arms (2)

Behavior changing intervention

OTHER

Thirty minutes behavior counselling (PPT.) to experimental group. BCI for SLT and BQ Use in Adolescents: A CRT

Behavioral: BCI for SLT and BQ Use in Adolescents: A CRT

Control Cluster

NO INTERVENTION

No thirty minutes behavior counselling (PPT.) to control group

Interventions

BCI for SLT and BQ Use in Adolescents: A CRT BEHAVIORAL

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.

Behavior changing intervention

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 11-16 years school going children with NO diagnosed oral cancer

You may not qualify if:

• Students younger or older than mentioned ages
• Diagnosed Oral Cancer patients

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

DOW University of Health Sciences

Karachi, Sindh, 75280, Pakistan

Location

Related Publications (1)

• Hussain 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 DERIVED

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Kashif Sahfique, PhD

  Dow University of Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 4, 2018
• Study Start: May 1, 2016
• Primary Completion: October 30, 2016
• Study Completion: December 30, 2018
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: when study results are published
• Access Criteria: confidentiality will need to be maintained

Locations

PA (1)