Disseminating and Implementing a Smoking Cessation Program Fro Pregnant and Postpartum Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 2
- 主要终点
- Biochemically verified smoking abstinence
研究概览
简要总结
This study tests whether a smoking cessation intervention for pregnant women that extends postpartum (Striving to Quit (STQ)) can be implemented and disseminated outside of the research environment that established its effectiveness (40% maintained biochemically verified 6-month abstinence). The research aim is:
Is Striving to Quit more effective in achieving postpartum smoking cessation than "First Breath," the current standard of care for pregnant women in Wisconsin who smoke?
250 women will be randomized into one of two study groups. Pregnant women in Group A (n=125) will receive the existing First Breath prenatal intervention. Those in Group B (Striving to Quit (STQ), n=125) will receive all Group A interventions, plus 1 additional prenatal home visit, 3 postpartum in-home smoking cessation counseling visits, 3 postpartum phone calls, and up to an additional $100 in gift cards. The primary outcome will be biochemically confirmed smoking cessation at 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
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant;
- •enrolled in First Breath;
- •Resides in Wisconsin counties of Calumet, Fond Du Lac, Kewaunee, Menominee, Oconto, Shawno, Sheyboygan, Winnebago, Door, Brown, Outagamie, Manitowac, or Waupaca;
- •English speaking;
- •willingness to quit or reduce smoking in next 30 days or if already quit, desire to remain quit after delivery;
- •daily smoking (at least 1 cigarette/day for at least 1 week in past 6 months;
- •willing to provide updates in contact information
排除标准
- •not pregnant;
- •not smoking in past 6 months;
- •involved in another smoking research study.
研究组 & 干预措施
First Breath
brief pre-natal smoking cessation counseling
干预措施: brief pre-delivery smoking cessation counseling (Behavioral)
Striving to Quit
Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives
干预措施: additional pre-delivery smoking cessation counseling (Behavioral)
Striving to Quit
Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives
干预措施: post- delivery smoking cessation counseling (Behavioral)
Striving to Quit
Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives
干预措施: incentives (Behavioral)
结局指标
主要结局
Biochemically verified smoking abstinence
时间窗: 6 months post intervention
Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)\<9ppm
次要结局
- Motivation to quit/remain quit(6 months post intervention)