Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence

说明(申请人提供)：怀孕期间戒烟的妇女很可能在产后恢复吸烟，从而将自己和婴儿置于危险之中。然而，到目前为止，烟草干预并没有阻止足够数量的妇女产后复发。因此，产后期是预防吸烟对妇女和儿童的负面健康后果的一个重要但在很大程度上尚未开发的机会。这项拟议的研究建立在调查人员的两条研究线索上：1)探讨体重担忧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，总体上改变健康行为，特别是戒烟。目的：首先，研究人员建议进行形成性工作，以开发一种创新的、增强的网络+电话治疗，旨在保持产后烟草戒断。然后，他们将进行一项小型随机、受控试点可行性研究，以评估这种新颖的、有针对性的、量身定做的产后复发预防网络+电话干预的可行性、可接受性和初步效果。方法：在这项应用的第一阶段，研究人员建议使用迭代治疗开发过程完成包括焦点小组(n=32)和可用性测试(n=40)的产后妇女的形成性工作。在第二阶段，调查人员将进行一项试点可行性研究，将100名怀孕期间戒烟并希望产后继续不吸烟的女性随机分配到增强网络+电话干预组(n=50)或仅使用基本网络信息的对照组(n=50)。怀孕后期的研究人员将使用商业名单服务提供的姓名和电话号码来招募女性。妇女只有在分娩后才能完全获得治疗计划。拟议的治疗计划将被设计成具有吸引力、互动性，并专门为产后妇女量身定做。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，干预与控制的有效性；以及c)对潜在机制的探索性分析(例如，调节因素，如孕前吸烟率、伴侣的烟草使用情况，以及其他人口统计因素，以及中介因素，如计划使用情况、体重问题、抑郁症状和感知的压力)。评估将在基线(通过电话)和产后三个月和六个月(在线)进行。无回应者将被传唤。好处：保持不吸烟的产后妇女降低了自己的发病率和死亡率，并保护了她们婴儿的健康。开发一种可行和可接受的基于网络的干预措施来维持烟草戒烟可能会对公众健康产生巨大的好处，因为它的成本低，覆盖范围广。

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.