Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence

描述（由申请人提供）：怀孕期间戒烟的妇女很可能在产后重新吸烟，从而使自己和婴儿处于危险之中。然而，迄今为止，烟草干预措施并没有阻止足够数量的妇女产后复发。因此，产后时期是预防吸烟对妇女和儿童的负面健康影响的一个重要但基本上尚未开发的机会。提出的研究建立在研究者的两条研究线索上：1)调查体重问题和情绪在产后复发预防中的关键作用；2)使用增强的基于网络的干预措施来改变健康行为，一般来说，特别是戒烟。目的：首先，研究者建议开展形成性工作，开发一种创新的，增强的Web+电话治疗，旨在维持产后戒烟。然后，他们将进行一项小型随机、对照的试点可行性研究，以评估这种新颖的、有针对性的、量身定制的产后复发预防Web+电话干预的可行性、可接受性和初步疗效。方法：在本应用程序的第一阶段，研究者建议使用迭代治疗开发过程，在焦点小组（n = 32）和可用性测试（n = 40）中完成涉及产后妇女的形成性工作。在第二阶段，研究人员将进行一项试点可行性研究，其中100名在怀孕期间戒烟并希望在产后保持不吸烟的妇女将被随机分配到增强网络+电话干预组（n= 50）或基本网络信息控制组（n= 50）。研究人员将利用商业名单服务提供的姓名和电话号码，通过电话招募怀孕后期的女性。妇女只有在分娩后才能获得全面的治疗方案。拟议的治疗方案将被设计为参与，互动，并专门为产后妇女量身定制。措施：评估将侧重于a)产后妇女基于网络的戒烟维持计划的可行性和可接受性；B)就烟草使用状况而言，干预措施与控制措施的效果；c)对假定的潜在机制进行探索性分析（例如，调节因素，如孕前吸烟率、伴侣吸烟和其他人口统计学因素，以及调节因素，如项目使用、体重担忧、抑郁症状和感知压力）。评估将在基线（通过电话）和产后3个月和6个月（在线）进行。无应答者将被呼叫。益处：产后妇女保持不吸烟可以降低自身发病和死亡的风险，并保护婴儿的健康。开发一种可行和可接受的基于网络的干预措施以维持烟草戒断，由于其成本低且覆盖面广，可对公共卫生产生重大益处。

DESCRIPTION (provided by applicant): Women who quit smoking for pregnancy are likely to resume tobacco smoking postpartum thereby placing themselves and their babies at risk. However, to date, tobacco interventions have not prevented sufficient numbers of women from relapsing postpartum. Thus, the postpartum period represents an important yet largely untapped opportunity to prevent the negative health consequences of smoking for women children. The proposed research builds on two threads of research by the investigators: 1) inquiry into the key role of weight concerns and mood in postpartum relapse prevention and 2) the use of enhanced Web-based interventions for health behavior change, generally, and tobacco cessation, specifically. Objectives: First, investigators propose to conduct formative work to develop an innovative, Enhanced Web+phone treatment designed to maintain tobacco abstinence postpartum. Then they will conduct a small randomized, controlled pilot feasibility study to assess the feasibility, acceptability, and initial efficacy of this novel, targeted, and tailored postpartum relapse prevention Web+phone intervention. Methods: In the first phase of this application, investigators propose to complete formative work involving postpartum women both in focus groups (n = 32) and in usability testing (n = 40) using an iterative treatment development process. In the second phase, investigators will conduct a pilot feasibility study in which 100 women who quit smoking for pregnancy and who want to remain nonsmokers postpartum will be randomly assigning to an Enhanced Web+phone intervention (n= 50) or a Basic Web Information Only control condition (n= 50). Women will be recruited by calls from research staff in late pregnancy using names and phone numbers provided by a commercial list service. Women will not be able to gain full access to the treatment program until after they have delivered. The proposed treatment program will be designed to be engaging, interactive, and tailored specifically to postpartum women. Measures: Assessment will focus on a) feasibility and acceptability of a Web-based tobacco abstinence maintenance program for postpartum women; b) efficacy of the intervention vs. the control in terms of tobacco use status; and c) exploratory analyses of putative underlying mechanisms (e.g., moderators, such as pre-pregnancy smoking rate, partner's tobacco use, and other demographic factors, and mediators, such as program usage, weight concerns, depressive symptoms, and perceived stress). Assessments will occur at baseline (via phone) and at three and six months postpartum (online). Non-responders will be called. Benefits: Postpartum women who maintain nonsmoking reduce risks of morbidity and mortality for themselves as well as protect the health of their baby. The development of a feasible and acceptable Web-based intervention to sustain tobacco abstinence could have substantial public health benefit because of its low cost and significant reach.