Striving to Quit: First Breath (STQ FB)
Striving to Quit: First Breath Tobacco Cessation Research
研究概览
地位
详细说明
Aim 1: To determine the extent to which contingent financial "treatment incentives" (i.e., incentives for biochemical verification visits, treatment engagement, and abstinence) versus "attendance incentives" (i.e., incentives for only attending the biochemical verification visits), increase rates of prenatal and postnatal smoking abstinence. Participants will be BadgerCare Plus members who are recruited into the First Breath program while pregnant.
Aim 2: To determine the extent to which treatment incentives, versus attendance incentives, increase rates of engagement in First Breath smoking cessation intervention when offered to pregnant and postpartum BadgerCare Plus members.
Aim 3: To determine the cost-effectiveness and reach of the First Breath intervention delivered to pregnant and postpartum smokers when it is paired with treatment incentives and when paired with only attendance incentives.
Aim 4: To determine if the First Breath intervention with treatment incentives, in comparison to that intervention with only attendance incentives, produces significantly greater benefits in pregnant and postpartum women with regards to nonsmoking health outcomes: i.e., reduced depression, increased levels of breast feeding, and greater perceived support.
Aim 5: To identify moderating and mediating effects of treatment incentives when offered in the context of the First Breath intervention delivered to pregnant and postpartum women.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Wisconsin
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Madison、Wisconsin、美国、53713
- Wisconsin Women's Health Foundation
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- pregnant women
- enrollment in Wisconsin Medicaid (BadgerCare Plus or Medicaid SSI)
- resides in study area
- member of participating Medicaid HMOs
- not involved in any other stop smoking research studies
- 18 or older
- English speaking
- smoked daily (at least one cigarette each day for at least one week) at some time within the last 6 months
- willingness to quit smoking, cut down, or stay quit
- willing to complete study visits and phone calls
- willing to provide updates in contact information
Exclusion Criteria:
- not enrolled in Wisconsin Medicaid (BadgerCare Plus or Medicaid SSI)
- not enrolled in study area
- not a member of participating Medicaid HMOs
- not pregnant or enrolled in First Breath
- less than 18 years of age
- non-English speaking
- does not smoke daily (at least one cigarette each day for at least one week) at least some time within the last 6 months
- not willing to complete study procedures and assessments or provide updated contact information
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Treatment incentives
Incentives for biochemical verification visits, treatment engagement, and abstinence
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Treatment Incentives - incentives for biochemical verification visits, treatment engagement, and abstinence
|
|
有源比较器:Attendance incentive
Incentives for only attending the biochemical verification visits
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Attendance Incentives - incentives for only attending the biochemical verification visits
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Abstinence from smoking
大体时间:Measured 6 months after births at follow-up assessment
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The data will be the biochemically confirmed reports of abstinence for the past 7 days (i.e., 7-day point-prevalence abstinence)
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Measured 6 months after births at follow-up assessment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Engagement in treatment
大体时间:Measured 12 months after birth at follow-up assessment
|
The primary analyses will compare number of calls and visits completed.
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Measured 12 months after birth at follow-up assessment
|
|
Cost-effectiveness
大体时间:Measured 12 months after birth
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The primary analysis will contrast the incremental costs of the treatment vs. attendance conditions by computing the Incremental Cost-Effectiveness Ratio (ICER) with regard to attaining 6-month abstinence.
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Measured 12 months after birth
|
合作者和调查者
调查人员
- 首席研究员:Timothy B. Baker, PhD、University of Wisconsin, Madison
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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