Comparative Evaluation of Efficacy of Different Methods of Tobacco Cessation Interventions Among BEST Employees in Mumbai : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 4,000
- 试验地点
- 2
- 主要终点
- Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees.
研究概览
简要总结
Tobacco use is the single most preventable cause of premature adult death globally. It is one of the major causes of death and disease in India, accounting for nearly 0.9 million deaths every year.
Bombay Electric Supply and Transport (BEST), one of the biggest public transport undertaking in Mumbai City, has imposed a ban on tobacco use in public transport buses and under Motor Vehicle Act has empowered the drivers and bus conductors to take suitable action against commuters found to be using tobacco. However in addition to commuters using tobacco in the BEST premises, large number of bus drivers and conductors are known to use tobacco on the job. There are various approaches to a tobacco cessation programme, like behavioural therapy, pharmacotherapy, providing self help material, telephone counseling, quit lines etc.
Hence in terms of the workplace environment, understanding the factors leading to tobacco use maintenance and the effective approaches for cessation is of critical importance for formulating workplace tobacco prevention and cessation interventions that are applicable to transport work employee settings. The success of these methods needs to be comparatively evaluated among the different forms of tobacco users. Hence, the present study will be undertaken with the following objectives:
详细描述
RESEARCH OBJECTIVES:
- To study the Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees in Mumbai
- To study the occupational correlates of tobacco consumption across various grades of BEST employees
- To educate them regarding hazards of tobacco.
- To offer BEST employees Preventive Oncology screening facilities and evaluate the compliance for screening and determine the rate of oral pre-cancers.
- To study the post-intervention KAP regarding tobacco
- To randomly assign the BEST employees using tobacco to one of the four tobacco cessation interventions and study the compliance to the same.
- To determine the rate of tobacco cessation after twelve months of follow-up.
- To comparatively evaluate the success of the four approaches of tobacco cessation, viz. providing self help material, telephone counseling, behavioural therapy and behavioural + pharmacotherapy, among users of different forms of tobacco.
Methodology:
Study Design: Four arm interventional study
Step 1: Around 4000 BEST employees in Mumbai will be enrolled after explaining the programme and obtaining informed consent. They will be interviewed with the help of a well structured questionnaire to collect information about their Knowledge, Attitudes and Practices (KAP) regarding tobacco, their attitudes and experiences regarding smoke free public places with specific reference to smoke free BEST buses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BEST employees in Mumbai
排除标准
- •BEST employees not willing to give consent
研究组 & 干预措施
Tobacco users: Self Help
Self-help intervention is defined as any manual or programme to be used by individuals to assist a quit attempt not aided by counsellors or group support.They include written materials on the health effects of tobacco, audio-or video tape or computer programmes.
干预措施: Tobacco users: Self Help (Other)
Tobacco users:Telephonic counseling
Telephone counseling is a way of providing individual counseling via telephone conversation or telephone hotlines. It can be proactive or reactive.
干预措施: Tobacco users:Telephonic counseling (Behavioral)
Tobacco users:Behavioural therapy Only
Behavioural therapy includes multiple sessions of Focus Group Discussion (FGD) and individual tobacco cessation counseling sessions. The participants in this group will be given advice to quit tobacco via multisession formal cognitive-behavioural therapy as per the Tobacco Cessation Clinic (TCC) guidelines.
干预措施: Tobacco users:Behavioural therapy Only (Behavioral)
Tobacco users:Pharmacologic
Pharmacotherapy in the form of Nicotine Replacement Therapy based on individual need assessment to relieve withdrawal symptoms in tobacco users when trying to quit.
干预措施: Tobacco users:Behavioural therapy Only (Behavioral)
Tobacco users:Pharmacologic
Pharmacotherapy in the form of Nicotine Replacement Therapy based on individual need assessment to relieve withdrawal symptoms in tobacco users when trying to quit.
干预措施: Tobacco users:Pharmacologic (Other)
结局指标
主要结局
Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees.
时间窗: 60 months
To study the Knowledge, Attitudes and Practices (KAP) regarding tobacco among BEST employees in Mumbai
次要结局
未报告次要终点
研究者
Gauravi Ashish Mishra
Associate Professor & Physician
Tata Memorial Hospital