Family Smoking Cessation in Romania Using Pregnancy as a Window of Opportunity

描述（由申请人提供）：本次IRSDA K 01重新提交推进了Fogarty的使命，即通过在美国和国外的研究机构之间建立伙伴关系来促进全球健康研究，并培训新的全球健康科学家。Cristian Meghea博士是密歇根州立大学（MSU）人类医学学院的助理教授，也是罗马尼亚克卢伊-纳波卡的Babes-Bolyai大学（BBU）的副研究员。该奖项将使Meghea博士成为一名独立资助的全球健康研究人员，有能力开发，评估和实施有效的，文化定制的和可持续的干预措施，以预防和减少在资源有限的环境中，如中欧和东欧的生育年龄段的家庭吸烟。 怀孕吸烟和产后复吸在罗马尼亚和中欧及东欧非常普遍，对妇女及其子女的健康造成终身负面影响。女性在怀孕期间持续吸烟的几率更高，一旦怀孕妇女戒烟，当男性伴侣也吸烟时，复发的几率更高。至关重要的是要解决夫妇在生育初期的吸烟行为。在罗马尼亚克卢伊-纳波卡由Meghea博士领导的正在进行的试点工作的基础上，通过BBU在与正在进行的试点相同的诊所进行的拟议研究的总体目标是调整，增强和测试基于证据的妊娠和产后夫妇戒烟干预措施的实施可行性和初步疗效，该干预措施始于妊娠早期并具有产后组成部分。该干预将基于动机和问题解决（MAPS）方法，在美国成功预防产后吸烟复发，通过关注戒烟的二元疗效，针对夫妇的吸烟行为，加强这一点。目标人群是罗马尼亚克卢伊-纳波卡的孕妇及其伴侣。 具体目标是：（1）在MAPS方法的基础上，制定一项经调整和加强的夫妇干预措施，以减少罗马尼亚的怀孕吸烟和产后复发。(2)进行一项随机对照试验，以测试文化适应的MAPS干预措施对预防夫妇在怀孕和产后吸烟的保真度。(3)在试点中检查实施的可行性和初步疗效，增加产妇怀孕戒烟和减少产后复发，与次要假设产妇吸烟减少和配偶戒烟，复发和减少。 本奖项中提出的这项研究将成为Meghea博士作为R 01申请提交的更大规模多中心临床试验的基础 在该奖项的第四年结束时，评估拟议的吸烟预防干预措施的有效性。如果在随后的R 01试验中证明有效，该干预措施具有广泛的人群影响和可持续性的高潜力。长期目标是在罗马尼亚国家卫生系统中采用该方案，作为现有“停止吸烟”国家方案的积极延伸，该方案包括一条戒烟热线。 为了实现这一长期研究议程，Meghea博士将参加课程，培训，并与优秀的导师团队合作，完善和发展五个专业领域：（1）全球健康和烟草控制;（2）行为健康，干预适应，传播和实施研究;（3）烟草和药物依赖流行病学;（4）围产期流行病学;（5）高级生物统计学。声音，主要的美国导师，将提供指导，在资源有限的环境中进行国际研究，并将是与其他同事建立联系的重要来源。15年来，他在罗马尼亚和邻近的巴尔干半岛领导了Fogarty D43培训和研究项目。阿德里安娜·巴班博士是罗马尼亚克卢伊-纳波卡在BBU的主要导师，她是健康心理学、预防和定性研究方面的专家。Kristie Foley博士，美国共同导师，在行为健康和烟草研究方面的专业知识，完善了这个由3名成员组成的核心指导团队。目前和未来与Foley博士的互动，她目前领导的Fogarty R 01自2012年以来在罗马尼亚建立烟草研究能力，以及她在该地区的合作者，为Meghea博士的职业发展和研究提供了非凡的机会。 科学顾问包括：Adrian Blow博士（夫妇和家庭健康干预）、William Wadland博士（戒烟和烟草依赖）、Jim Anthony博士（烟草和药物依赖流行病学）、奈杰尔Paneth博士（围产期流行病学）、大卫维特博士（MAPS的最初开发者之一）和罗马尼亚“停止吸烟”计划的国家协调员Teodora Ciolompea博士。Ciolompea博士将通过促进罗马尼亚国家卫生系统未来采用干预措施，在干预措施的适应、实施和可持续性方面发挥关键的咨询作用。 获得真正的概念队列，在同一诊所进行产前和产后护理，分娩和重复怀孕，以及高吸烟率和罕见的多种药物使用，有可能比我们在美国更快，更便宜，更有效地推进健康发现。该奖项旨在解决烟草使用问题，这是Fogarty和NIH在全球健康研究中的一个关键优先事项，并将为Meghea博士提供参与和维持具有重大影响的强大研究计划的机会。

DESCRIPTION (provided by applicant): This IRSDA K01 resubmission advances the Fogarty mission of facilitating global health research through building partnerships between research institutions in the U.S. and abroad, and training new global health scientists. Dr. Cristian Meghea is an Assistant Professor in the College of Human Medicine, at Michigan State University (MSU) and an Associated Researcher at Babes-Bolyai University (BBU), in Cluj-Napoca, Romania where he was born and raised. This award will prepare Dr. Meghea to establish himself as an independently- funded global health researcher with capacity to develop, evaluate, and implement effective, culturally-tailored, and sustainable interventions to prevent and reduce smoking in families during the reproductive years in resource limited settings such as Central and Eastern Europe. Pregnancy smoking and postnatal relapse are highly prevalent in Romania and Central and Eastern Europe, with lifetime negative health effects for the women and their children. There are higher odds of female smoking persistence during pregnancy, and of relapse once pregnant women quit, when the male partner also smokes. It is critically important to address the smoking behavior of couples at the beginning of reproductive life. Building on ongoing pilot work led by Dr. Meghea in Cluj-Napoca, Romania, the overall objective of the proposed research, conducted through BBU in the same clinic as the ongoing pilot, is to adapt, enhance, and test the implementation feasibility and preliminary efficacy of an evidence-based pregnancy and postnatal couple intervention for smoking cessation that begins early in pregnancy and has a postnatal component. The intervention will be based on the motivation and problem solving (MAPS) approach, successful in preventing smoking relapse postpartum in the US, which will be enhanced by targeting the couples' smoking behavior by focusing on dyadic efficacy for smoking cessation. The target population is primigravida pregnant women and their partners in Cluj-Napoca, Romania. The specific aims are: (1) To develop an adapted and enhanced couple intervention to reduce pregnancy smoking and postpartum relapse in Romania based on the MAPS approach. (2) To conduct a pilot randomized controlled trial to test the fidelity of the culturally adapted MAPS intervention enhanced for couples smoking prevention during pregnancy and postpartum. (3) To examine in the pilot the implementation feasibility and initial efficacy in increasing maternal pregnancy smoking cessation and reducing postnatal relapse, with secondary hypotheses regarding maternal smoking reduction and spousal cessation, relapse, and reduction. This study proposed in this award will form the basis for a larger, multicenter clinical trial that will be submitted by Dr. Meghea as an R01 application by the end of the 4th year of this award to evaluate the effectiveness of the proposed smoking prevention intervention. If proven effective in the subsequent R01 trial, the intervention has a high potential for broad spectrum population impact and sustainability. The long-term goal is the adoption in the national Romanian health system as a proactive extension of the existing STOP SMOKING national program which includes a quitline. To pursue this long-term research agenda, Dr. Meghea will enroll in courses, trainings, and work with an outstanding team of mentors to refine and develop five areas of expertise: (1) Global health and tobacco control; (2) Behavioral health, intervention adaptation, dissemination, and implementation research; (3) Tobacco and drug dependence epidemiology; (4) Perinatal epidemiology; (5) Advanced biostatistics. Dr. Voice, the primary US mentor, will provide mentorship on conducting international research in resource limited settings, and will be an important source for networking with other colleagues. For over 15 years, he has lead a Fogarty D43 training and research program in Romania and the neighboring Balkans. Dr. Adriana Baban, the primary Romania mentor in Cluj-Napoca at BBU, is an expert in health psychology, prevention, and qualitative research. Dr. Kristie Foley, US Co-Mentor, with expertise in behavioral health and tobacco research rounds out this 3-member core mentoring team. The current and future interactions with Dr. Foley, the Fogarty R01 she currently leads building tobacco research capacity in Romania since 2012, and her collaborators in the region are extraordinary opportunities for Dr. Meghea's career development and research. Scientific advisors include: Dr. Adrian Blow (couples and family health interventions), Dr. William Wadland (smoking cessation and tobacco dependence), Dr. Jim Anthony (tobacco and drug dependence epidemiology), Dr. Nigel Paneth (perinatal epidemiology), Dr. David Wetter, one of the original MAPS developers, and Dr. Teodora Ciolompea, the national coordinator of the STOP SMOKING program in Romania. Dr. Ciolompea will have a key advisory role in the intervention adaptation, implementation and sustainability by facilitating the future adoption of the intervention in the national Romanian health system. The access to a true conception cohort with prenatal and postnatal care, delivery, and repeat pregnancies in the same clinics, and the high smoking rate and rare polydrug use, have the potential to advance health discoveries faster, cheaper, and more efficiently than we could in the US. This award addresses tobacco use, a key Fogarty and NIH priority in global health research and will provide Dr. Meghea the opportunity to engage in and maintain a strong research program with a major impact.