Striving to Quit: First Breath Tobacco Cessation Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,100
- 试验地点
- 2
- 主要终点
- Abstinence from smoking
研究概览
简要总结
This study is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to Medicaid BadgerCare Plus pregnant smokers.
详细描述
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Abstinence from smoking
时间窗: Measured 6 months after births at follow-up assessment
The data will be the biochemically confirmed reports of abstinence for the past 7 days (i.e., 7-day point-prevalence abstinence)
次要结局
- Engagement in treatment(Measured 12 months after birth at follow-up assessment)
- Cost-effectiveness(Measured 12 months after birth)