Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- All tobacco abstinence
研究概览
简要总结
This study seeks to develop and test a Web-based tobacco relapse prevention program targeting postpartum women who quit smoking for pregnancy. Participants are randomly assigned to one of two conditions: (1) an Enhanced Web+phone Condition that receives access to an interactive Web-based intervention plus up to 3 brief supportive phone calls from a personal coach; (2) A Basic Web Information-Only Control Condition that receives access to an informational website plus an introductory phone call. The hypothesis is that Women in the Enhanced Condition will be more successful in avoiding tobacco relapse than women assigned to the Basic Control Condition.
详细描述
The primary aims of this project are to:
- Adapt and refine an Enhanced Web+phone intervention for the maintenance of tobacco abstinence postpartum.
- Evaluate the feasibility and acceptability of the Enhanced Web+phone tobacco abstinence maintenance program for postpartum women.
Aim 2.1 The investigators hypothesize that the intervention will be feasible as assessed by women's report of helpfulness, relevance and program usability.
Aim 2.2 The investigators hypothesize that the intervention will be acceptable to postpartum women as measured by engagement in and use of the program. 3. Estimate the initial efficacy of the Enhanced Web+phone intervention on tobacco abstinence at 3 and 6 months postpartum relative to a Basic Web Information-Only control.
Aim 3.1 The investigators hypothesize that, relative to the Basic Web Information-Only control, the Enhanced Web+phone intervention will be associated with 10-points greater prolonged abstinence rates at 3 and 6 months postpartum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Smoked at least 5 cigarettes/day for at least 1 of the 3 months prior to becoming pregnant
- •No smoking during weeks 34 to 38 of pregnancy
- •Able to read English
- •At least 18 years of age
- •Use Web e-mail account at least once per week
- •Completed informed assent/consent.
排除标准
- 未提供
研究组 & 干预措施
Enhanced Web+phone
Engaging and interactive website access plus phone calls from personal coach.
干预措施: Web+phone (Behavioral)
Basic Static Web
Static website access only, only introductory call.
干预措施: Web+phone (Behavioral)
结局指标
主要结局
All tobacco abstinence
时间窗: 3 and 6 months postpartum
Measure change in 7-day point all tobacco abstinence and change in prolonged abstinence between 3 and 6 months postpartum.
次要结局
- Potential predictors of postpartum tobacco relapse(6 months postpartum)