Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence

描述（由申请人提供）：因怀孕而戒烟的妇女很可能在产后恢复吸烟，从而使自己和婴儿处于危险之中。然而，迄今为止，烟草干预措施未能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健康的负面影响的一个重要但基本上尚未利用的机会。拟议的研究建立在研究人员的两个研究线索上：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，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，旨在保持产后戒烟。然后，他们将进行一项小型随机对照试点可行性研究，以评估这种新颖的、有针对性的、量身定制的产后复发预防网络+电话干预的可行性、可接受性和初步疗效。研究方法：在本申请的第一阶段，研究人员建议使用迭代治疗开发过程完成涉及焦点小组（n = 32）和可用性测试（n = 40）中的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名因怀孕而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（n= 50）或仅基本网络信息对照条件（n= 50）。将通过研究人员在怀孕后期使用商业列表服务提供的姓名和电话号码来招募女性。妇女在分娩后才能完全获得治疗方案。拟议的治疗计划将被设计为参与，互动，并专门为产后妇女量身定制。措施：评估的重点是：a）基于网络的产后妇女戒烟维持计划的可行性和可接受性; B）在烟草使用状况方面干预与控制的有效性;以及c）对假定的潜在机制（例如，调节因素，如孕前吸烟率，伴侣的烟草使用，和其他人口统计学因素，和中介，如程序的使用，体重问题，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。好处：产后妇女保持不吸烟，可降低自身发病和死亡的风险，并保护婴儿的健康。开发一种可行的和可接受的基于网络的干预措施来维持烟草戒烟，由于其成本低和覆盖面广，可能会产生重大的公共卫生效益。

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.