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临床试验/CTRI/2024/04/066330
CTRI/2024/04/066330尚未招募1 期

Efficacy of Brief Intervention (BI) module in enhancing abstinence period among smokeless tobacco (SLT) users in selected community of Assam.

Sagarika Chetia1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
86
试验地点
1
主要终点
To determine the efficacy of brief intervention (BI) module in enhancing abstinence, awareness and perception on smokeless tobacco use.

研究概览

简要总结

Background: The use of tobacco is prevalent in all age groups throughout the world. In India, its use is culturally accepted in most parts of the country, and as such, it is also easily available. As per the Global Adult Tobacco Survey 2 (GATS 2) fact sheet for Assam (2016–17), the prevalence of smokeless tobacco use has increased significantly (i.e., 41.7%) from GATS 1 by 9 percentage points. Many studies have been conducted on smoking tobacco, but only a handful of interventional research studies are available on the use of smokeless tobacco in India, especially in the NE region. The aim of the study is to assess the efficacy of the Brief Intervention (BI) module for smokeless tobacco users in a selected villages of Sonitpur district, Assam. Methodology: The researcher will adopt arandomized controlled trial research design. Setting will be selected villages of Sonitpur district of Assam, and population will be smokeless tobacco (SLT) users. In the first phase of the study the content of the brief intervention module will be prepared based on the existing models and will be validated from experts in different related fields. Then in the second phase of the study, three randomly selected villages under Bihaguri PHC will be visited and houses will be selected randomly by using random number table. A total of 86 samples will be included in the study as per inclusion and exclusion criteria and by using lottery method randomization will be done to allocate samples in experimental and waitlist control group. Three visits will be done to the houses at one month interval. On the first day socio-demographic information will be collected from selected participants by using a socio-demographic proforma and pretest will be conducted for both experimental and waitlist control group by using the Fragerstrom Nicotine Dependence Scale (FTND), the Fragerstrom Nicotine Dependence-Smoking Tobacco (FTND-ST) Scale, The Alcohol, Smoking and Substance Involvement Screening Test V3.0 (ASSIST-V3.0), the University Rhode Island Change Assessment Scale (URICA), and semi-structured questionnaires to assess abstinence period, perception, and awareness regarding smokeless tobacco use. On the same day Brief Intervention will be provided only to the experimental group by using validated Brief Intervention Module. 2nd visit will be done at one month after 1st visit and posttest will be conducted for both the groups. On that day, after post test brief intervention will be provided to the waitlist control group. On the third visit booster session will be conducted for experimental group and posttest will be done for waitlist control group. After the required number of participants have provided their data, all of the data will be gathered and statistically examined by using descriptive and inferential statistics.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age- ≥18 to 60 years, current user of smokeless tobacco (SLT), those occasionally use smoking tobacco and who can read and write Assamese.

排除标准

  • Only Betelnut users (without tobacco), person using other form of tobacco, other substance users, people attended any awareness program, people seeking treatment for nicotine dependence.

结局指标

主要结局

To determine the efficacy of brief intervention (BI) module in enhancing abstinence, awareness and perception on smokeless tobacco use.

时间窗: 1st time point: Baseline (at the time of random allocation of participants to the experimental and waitlist control group and pretest) | 2nd time point: At one month of 1st session | 3rd time point: At one month of 2nd session

次要结局

  • To assess the socio-demographic profile of participants using smokeless tobacco in selected villages of Sonitpur district, Assam.(To explore the consumption of smokeless tobacco use in selected villages of Sonitpur district, Assam.)

研究者

发起方
Sagarika Chetia
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sagarika Chetia

LGB Regional Institute of Mental Health

研究点 (1)

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