Muslim Communities Learning About Second-hand Smoke - MCLASS pilot cluster randomised controlled trial

在英国，40%的孟加拉国男性和29%的巴基斯坦男性经常吸烟，而全国平均水平为24%。二手烟（SHS）在他们的家庭中也很常见，这对非吸烟者，特别是儿童来说是一个严重的健康危害。家庭中的吸烟限制减少了儿童接触SHS的机会。此外，吸烟者更有可能戒烟，年轻人不太可能开始吸烟，如果生活在家庭吸烟限制。我们的目标是确定有效的方法，保护儿童和非吸烟的成年人从SHS，并减少吸烟，提高戒烟率在英国贫困社区。我们在一个有大量巴基斯坦裔人口的地方，采用三种方法（学校、医疗保健组织和社区组织，特别是清真寺）对“无烟家园”进行了初步研究。然而，研究设计排除了对其有效性的可靠推断。我们现正着手确定通过这三条路线提供的“无烟家园”的有效性。我们已经获得了研究赠款，以测试其中两种方法（学校和医疗保健）。这一采用社区信仰领袖方法的申请旨在补充现有的工作，并将导致最终的审判申请。为了确定这种方法的有效性，需要进行随机分组试验。然而，在进行大型（且昂贵）的确定性研究之前，我们计划进行一项试点试验。“无烟家园”试验计划将为日后的最终试验计划提供设计参考。我们的研究目标包括：确定集群（清真寺）的数量和每个集群的规模（受试者）主要试验所需的数据，确定招募和失访率以及其他统计要求（效果大小和类内系数）;确定实施干预措施的可行性、可接受性和资源需求，并评估结果;我们将进行一项为期24个月的“无烟之家”的随机对照试点试验，并进行初步的健康经济学和定性研究。审判将在14座清真寺进行，这些清真寺主持集体祈祷，召集妇女学习小组，并定期为儿童开设古兰经课程。我们开发了一个名为“无烟家庭：穆斯林宗教教师工具包”的工具包，其中包括一系列详细介绍有关吸烟、SHS和“无烟家庭”的重要信息的情况说明，一系列传播重要信息的活动，以及规划和监测这些活动的工具。我们还准备了一套培训教材，使三个主要的穆斯林宗教领袖群体，即主要与成年男性交往的伊玛目、主要与儿童交往的古兰经教师和妇女团体领袖，能够在各自的会众中使用这套教材。我们的目标是从每个清真寺招募至少50个家庭，其中至少有一名吸烟的成年居民和至少一名儿童或一名不吸烟的成年人。在研究的每个组中，将在干预前后测量所有结局。我们将测量家庭中非吸烟者的唾液可替宁水平作为主要结局。它是一种广泛认可的检测主动吸烟和被动吸烟的方法。次要结果包括评估家庭吸烟限制，成年人的吸烟状况和他们的戒烟意图，以及家庭卫生服务的使用。一个有相关利益攸关方参与的多学科小组将领导这项研究。研究结果将分别在同行评审期刊和科学会议上发表和介绍。

In the UK, 40% of Bangladeshi and 29% of Pakistani men smoke cigarettes regularly compared to the national average of 24%. Second-hand smoking (SHS) is also common in their households, which is a serious health hazard to non-smokers, especially children.Smoking restrictions in households reduces children's exposure to SHS. In addition, smokers are more likely to quit and young people are less likely to initiate smoking if living in households with smoking restrictions.Our aims are to identify effective ways of protecting children and non-smoking adults from SHS, and to reduce uptake of smoking and improve smoking quit rates in deprived communities in the UK. We carried out a preliminary study of 'Smoke Free Homes' using three approaches (schools, healthcare organizations and community organizations, in particular mosques) in a locality with a significant Pakistani-origin population. However, the study design precluded reliable inferences about its effectiveness. We are now embarking on to establish the effectiveness of 'Smoke Free Homes' delivered through each of these three routes. We have secured research grants to test two of these approaches (school & healthcare). This application pursuing the community-faith leaders approach aims to complement the existing strands of work and will lead to a definitive trial application. In order to establish the effectiveness of this approach, a cluster-randomized trial is needed. However, prior to a large (and expensive) definitive study we plan to carry out a pilot trial. A pilot trial of 'Smoke Free Homes', will inform the design of a definitive trial in future. Our research objectives include: establishing the number of clusters (mosques) and the size of each cluster (participants) required for the main trial, ascertain recruitment and loss to follow-up rates, and other statistical requirements (effect size and intra-class coefficient); establishing feasibility, acceptability and resource requirements for delivering the intervention and assessing outcomes; and understanding the extent to which 'Smoke Free Homes' can be integrated into mosques' routine.We will carryout a cluster randomised controlled pilot trial of 'Smoke Free Homes' over 24 months with an embedded preliminary health economic and a qualitative study. The trial will be carried out in fourteen mosques, which host communal prayers, convene study circles for women and have regular Qur'an classes for children. We developed a toolkit titled "Smoke Free Homes: A toolkit for Muslim religious teachers" which consists of a series of fact sheets detailing key information on smoking, SHS and 'Smoke Free Homes', a series of activities through which the key information can be disseminated, and tools to plan and monitor these activities. We have also prepared a training package to enable three key groups of Muslim religious leaders i.e. Imams who mainly interact with adult males, Qur'an teachers who mainly interact with children and women circle leaders to use this toolkit with their respective congregations.No intervention will be carried out in the control arms until after the trial. From each mosque, we aim to recruit at least 50 households with at least one adult resident who smokes cigarette and at least one child or a non-smoking adult. All outcomes will be measured before and after the intervention in each arm of the study. We will measure salivary cotinine levels in non-smokers in the households as the primary outcome. It is a widely recognized method for detecting both active and passive smoking. Secondary outcomes include assessment of smoking restrictions at home, smoking status of adults' and their intention to quit, and family health service use. A multidisciplinary team with the engagement of relevant stakeholders will lead the research. Research findings will be published and presented in peer-reviewed journals and scientific meetings respectively.