Behavior Changing Intervention for Smokeless Tobacco and Betel Quid Use in Adolescents: A Cluster-Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,200
- 试验地点
- 2
- 主要终点
- Changing perceptions regarding SLT and BQ use
研究概览
简要总结
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
详细描述
In lieu of the increasing disease burden of oral cancer in South Asian countries due to increasing popularly fashionable SLT consumption; the objective is to develop (i) a BCI pertinent to socio-cultural aspect for South Asian SLT users, followed by (ii) assessing its efficacy in changing perception and dependency regarding SLT use in high risk group of 11-16 years old school going children of Karachi of both private and public sector schools.
It is also aimed to deconstruct the BCI to establish which components of our BCT are more useful in making an intervention most efficient by using sub-indices of fidelity index to assess the adherence and quality of each component of intervention. Each component will be scored using fidelity index by a neutral trained listener each time intervention is delivered by a trained personnel.
Quantitatively, the objectives of the study are to:
i. measure SLT/ or BQ use prevalence amongst adolescents of 11-16 years ii. assess the reasons behind their use of SLT/ or BQ in users (both intervention and control clusters) by using Reasons for Betel Quid Chewing Scale (RBCS).
iii. evaluate the dependency on SLT/ or BQ in users (both intervention and control clusters) using Fagerstörm Tobacco and Nicotine Dependency scale for Smokeless Tobacco (FTND-ST) and Betel Quid Dependency by using Betel Quid Dependency Scale (BQDS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •11-16 years school going children with NO diagnosed oral cancer
排除标准
- •Students younger or older than mentioned ages
- •Diagnosed Oral Cancer patients
研究组 & 干预措施
Behavior changing intervention
Thirty minutes behavior counselling (PPT.) to experimental group. BCI for SLT and BQ Use in Adolescents: A CRT
干预措施: BCI for SLT and BQ Use in Adolescents: A CRT (Behavioral)
Control Cluster
No thirty minutes behavior counselling (PPT.) to control group
结局指标
主要结局
Changing perceptions regarding SLT and BQ use
时间窗: 3 months
modified Global Youth Tobacco Survey will be used to assess the perceptions of adolescents
次要结局
- prevalence of OPMLs in the users of SLT and BQ(three months)
- prevalence of SLT and BQ use in 11-16-year-old(3 months)
- perceptions regarding warning labels on SLT and BQ product pack(three months)
- Quit/quit attempts by the participants(three months)
研究者
Prof. Dr. Azmina Hussain
Professor
Dow University of Health Sciences