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临床试验/CTRI/2025/08/093296
CTRI/2025/08/093296尚未招募不适用

Effectiveness of Brief Intervention for Tobacco Cessation Education (BITCE) among Tobacco Users in a Rural Community: A Quasi-experimental Study

Dr. NTR University of Health Sciences1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
试验地点
1
主要终点
Reduction or cessation of tobacco use among participants

研究概览

简要总结

This study aims to assess the effectiveness of brief behavioral interventions and nicotine replacement therapy (BITCE) in helping tobacco users quit and sustain abstinence in a rural area of Kuppam, Andhra Pradesh. It is a community-based quasi-experimental study involving 400 adult participants selected via multistage random sampling.

Participants aged 18-60 years with mild to moderate nicotine dependence (as assessed by ICD-11 and the Fagerström Test) will receive behavioral interventions using the NIMHANS 5A and 5R approach, along with nicotine replacement therapy. Interventions will be group-based and conducted at the panchayat level. Follow-ups will be conducted at regular intervals over one year. Statistical analysis will include paired t-tests and chi-square tests to compare outcomes before and after the intervention. Ethics approval has been obtained from the Human Ethics Committee and informed consent from the participants will be obtained.

This study will evaluate the effectiveness of community-based brief interventions for tobacco cessation and identify implementation challenges at the grassroots level. It aligns with India’s vision for Amrit Kaal by addressing rural health burdens. By complementing initiatives like Nasha Mukth Bharat Abhiyaan, it will aid in strengthening the tobacco control framework.

研究设计

研究类型
Interventional
分配方式
Na
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

  • Adult men and women aged 18 years to 60 years residing in the region for at least a year
  • Participants diagnosed to be nicotine dependent as per ICD 11 criteria
  • Subjects with mild and moderate severity Fagerstrom Test
  • Willingness to reside in the area for the next two years and available for follow up.

排除标准

  • Pregnant women
  • Bedridden patients and individuals with other mental illnesses
  • Individuals who are already seeking treatment for tobacco cessation
  • Individuals with other psychoactive drug use.

结局指标

主要结局

Reduction or cessation of tobacco use among participants

时间窗: 1 year

次要结局

  • .Changes in Fagerström Nicotine Dependence scores from baseline to post-intervention.(.Barriers and challenges encountered during the implementation of BITCE in a rural community setting)

研究者

发起方
Dr. NTR University of Health Sciences
申办方类型
Other [Public Health Sciences University]
责任方
Principal Investigator
主要研究者

Dr Praveen Kumar B A

PES Institute of Medical Sciences and Research

研究点 (1)

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