A multicomponent intervention to reduce home-exposure to second-hand smoke (SHS) during pregnancy and postnatal period: a randomised controlled trial

南亚是世界上男性吸烟者人数最多的地区之一。因此，南亚超过三分之一的孕妇在家中暴露在二手烟中。这对母亲(如与心脏和肺有关的疾病增加)以及新生儿(死产、早产和与肺有关的疾病的可能性更高)都有严重的健康后果。另一方面，产前为改变整个家庭中与健康有关的行为提供了机会之窗。减少孕妇接触二手烟的有效干预措施已在较富裕的国家成功尝试，但尚未在中低收入国家大规模实施。我们提议的项目解决了两个这样的国家--印度班加罗尔市区和孟加拉国科米拉郊区的这一差距。这些地点所在的地区是全球二手烟造成的疾病负担最大的地区。该项目有两个广泛的目标：第一个目标是将已知有效的现有知识转化为可接受和可行的干预措施，可提供给妇女及其家庭成员。这可能包括告知女性及其家人体内二手烟的水平，通过对她的唾液进行简单的测试来测量；教育全家人二手烟对母亲和婴儿的有害影响；以及使用心理学和行为科学领域的“交流技术”鼓励丈夫和其他家庭成员在怀孕母亲面前改变吸烟的习惯。第二个目标是应用科学方法来测试这一干预措施在减少孕妇和新生儿暴露于二手烟方面的有效性，并确定实施这种干预措施的成本和效益。该项目将分两个阶段进行。在第一阶段(发展阶段：0-12个月)，我们将采访孕妇、她们的丈夫和其他家庭成员，以深入了解围绕家庭中二手烟问题的所有问题，包括我们在尝试改变这一点时可能面临的障碍。我们将利用这些信息制定一种干预措施，以可接受的方式克服这些障碍。在这一阶段，我们还将帮助我们的印度和孟加拉国同行获得制定这种干预措施所需的专业知识，并用科学方法对其进行测试。在第二阶段(试验阶段-13-36个月)，我们将进行一项严格的科学实验(称为随机对照试验)，将我们的新干预措施与通过宣传单进行的二手烟教育进行比较。我们将确定920名怀孕早期的母亲，她们在家中暴露于二手烟(每个地点460人)，接受干预或只接受教育宣传单。这将以这样一种方式进行，即每个妇女都有平等的机会进入任何一个群体。当我们将这些母亲和家庭招募到我们的研究中时，我们将收集所有这些母亲和家庭的信息，然后在怀孕后期，即两组都接受了两种干预措施的3个月后收集信息。我们还将在新生儿出生时收集信息，然后在他/她出生后3个月收集信息。收集的资料将包括怀孕和分娩的情况；母亲和婴儿体内通过唾液测试产生的二手烟水平；母亲和婴儿的健康状况，以及家庭成员的吸烟行为。我们将比较两组收集的信息，看看干预效果如何。我们还将从一些家庭收集更详细的信息，以了解干预是如何起作用的(或在某些情况下没有起作用)。这项研究的结果将在整个项目期间与主要的学术、政策和社区利益攸关方分享。

South Asia has one of the highest numbers of male smokers anywhere in the world. As a result, over a third of pregnant women in South Asia are exposed to second-hand smoke in their homes. This has serious health consequences for both mothers (such as increased heart- and lung-related illnesses) as well as the newborn (higher chances of stillbirth, being born prematurely and lung-related illnesses). On the other hand, the antenatal period provides a window of opportunity to change health-related behaviours in the entire family. Interventions that are effective in reducing the exposure of pregnant women to second-hand smoke have been tried successfully in richer countries but have not been adapted for large-scale implementation in lower and middle-income countries. Our proposed project addresses this gap in two such countries - urban Bangalore, India and peri-urban Comilla, Bangladesh. The sites are situated in a region with the greatest burden of disease from the effects of second-hand smoke globally. The project has two broad aims: The first is to adapt existing knowledge about what is known to work, into an acceptable and feasible intervention that can be delivered to the woman and her family members. This may include informing the woman and her family about the levels of second-hand smoke in her body measured by a simple test on her saliva; educating the whole family about the harmful effects of second-hand smoke on the mother and baby; and using 'communication-techniques' from the field of psychology and behavioural sciences to encourage husband and other family members to change the habit of smoking in the pregnant mother's presence. The second aim is to apply scientific methods to test the effectiveness of this intervention in reducing the exposure of pregnant women and newborn to second-hand smoke in both sites, and to determine the costs versus benefits of implementing such an intervention. The project will be undertaken in two phases. In Phase 1 (Development Phase: Months 0-12), we will interview pregnant women, their husbands, and other family members to gain an in-depth understanding of all the issues surrounding the problem of second-hand smoke in the household, including barriers we may face in trying to change this. We will use this information to develop an intervention that can overcome these barriers in an acceptable way. During this phase, we will also help our Indian and Bangladeshi counterparts gain the expertise needed to develop such interventions, and in scientific methods to test them. In Phase 2 (Trial Phase - Months 13-36), we will conduct a strict scientific experiment (called a randomized controlled trial) to compare our new intervention with education about second-hand smoke through a leaflet. We will identify 920 mothers in early pregnancy, who are exposed to second hand smoke at home (460 at each site), to receive either the intervention or only the educational leaflet. This will be done in a way that each woman has an equal chance of being in either group. We will collect information on all these mothers and families when we recruit them into our study and then in late-pregnancy, 3 months after both groups have received either of the two interventions. We will also collect information when the new baby is born, and then 3 months after his/her birth. The information collected will include how the pregnancy and birth fared; levels of second-hand smoke in the mothers' and infants' body through a test on their saliva; health of both mother and baby, and smoking behaviours of family members. We will compare the information collected in the two groups to see how well the intervention did. We will also collect more detailed information from some families to understand how the intervention worked (or failed to work, in some cases). The findings from the study will be shared with key academic, policy and community stakeholders throughout the duration of the project.