A cluster randomized controlled trial of a brief tobacco cessation intervention for low-income communities in India: study protocol
A cluster randomized controlled trial of a brief tobacco cessation intervention for low-income communities in India: study protocol
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DOI：
10.1111/add.12420
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发表时间：
2014-03-01
期刊：
影响因子：
6
通讯作者：
West, Robert
中科院分区：
文献类型：
--
作者：
Sarkar, Bidyut K.;Shahab, Lion;West, Robert
背景印度有2.75亿成年烟草使用者，据估计，烟草使用每年导致该国100多万人死亡。迫切需要制定和评估负担得起、切实可行和可扩展的干预措施，以促进戒烟。由于烟草的使用是如此有害，长期戒烟成功率哪怕只提高1个百分点，都会对公共卫生产生重要影响。该协议文件介绍了一个大型的随机对照试验，其目的是评估一个简短的可扩展的戒烟干预措施的有效性提供训练有素的卫生专业人员作为一个外展计划在贫困的城市communityinIndia.Methods/designThis是一个务实的，双臂，以社区为基础的集群随机对照试验，重点是烟草使用者在低收入社区的基本原理和方法。治疗组是一个简短的干预，包括简短的建议，包括使用简单的瑜伽呼吸练习（BA-YBA）进行控制渴望的训练，对照组是非常简短的建议（BRA）。在32个组别中，16个组别会分配予干预组，16个组别会分配予控制组，每组有31名参加者，合共992名参加者。主要结果的措施将遵循罗素标准：自我报告的持续禁欲至少6个月后，在最后的后续确认的干预唾液cotinine.DiscussionThis试验将通知国家和国际政策提供可扩展的和负担得起的简短的外展干预措施，以促进烟草使用的戒烟在低资源的设置，烟草使用者有有限的机会获得医生和药物。
BackgroundIndia has 275 million adult tobacco users and tobacco use is estimated to contribute to more than a million deaths in the country each year. There is an urgent need to develop and evaluate affordable, practicable and scalable interventions to promote cessation of tobacco use. Because tobacco use is so harmful, an increase of as little as 1 percentage point in long-term quit success rates can have an important public health impact. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of a brief scalable smoking cessation intervention delivered by trained health professionals as an outreach programme in poor urban communities in India.Methods/designThis is a pragmatic, two-arm, community-based cluster randomized controlled trial focused on tobacco users in low-income communities. The treatment arm is a brief intervention comprising brief advice including training in craving control using simple yogic breathing exercises (BA-YBA) and the control arm is very brief advice (VBA). Of a total of 32 clusters, 16 will be allocated to the intervention arm and 16 to the control arm. Each cluster will have 31 participants, making a total of 992 participants. The primary outcome measure will follow the Russell Standard: self-report of sustained abstinence for at least 6 months following the intervention confirmed at the final follow-up by salivary cotinine.DiscussionThis trial will inform national and international policy on delivery of scalable and affordable brief outreach interventions to promote tobacco use cessation in low resource settings where tobacco users have limited access to physicians and medications.