Smoking Resumption-Prevention is Postpartum Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 386
- 试验地点
- 2
- 主要终点
- To assess the efficacy of an intervention in preventing or delaying postpartum smoking resumption among women who stop smoking during pregnancy.
研究概览
简要总结
STUDY PURPOSE:
Aim 1. To assess the efficacy of an intervention in preventing or delaying postpartum smoking resumption among women who stop smoking during pregnancy.
Aim 2. To determine the association of baseline risk assessment variables (dependence, motivation, self-efficacy, concerns for the fetus, changes in sensory response to tobacco, depression, weight concerns, and partner/household smoking and support) with time to resumption.
A two-arm randomized controlled trial will be conducted. Women's risk for resumption will be assessed at 4 time-points.
- Between 28 and 34 weeks of pregnancy
- 6-weeks postpartum
- 6-months postpartum
- 12-months postpartum
Women who report not smoking at any of the assessment points will be asked to provide a saliva sample for analysis of tobacco constituents and a breath sample to assess carbon monoxide. Bio-behavioral and pregnancy-specific factors will be used to triage women to one of four levels of stepped-care that includes:
- One in-person counseling session and at least one telephone session during pregnancy and from 6 to 11 telephone sessions over the first 9-months postpartum.
- Risk profiles will be used to match the intervention to each woman's needs.
- Women randomized to the control arm will receive the booklet, Forever Free for Baby and Me and usual prenatal and postpartum care.
We are recruiting 400 women for this study from 11 sites in the Durham/ Raleigh/ Chapel Hill NC area and Fayetteville NC.
详细描述
STUDY DESIGN:
A two-arm randomized controlled trial will be conducted. Women's risk for resumption will be assessed at 4 time-points.
- Between 28 and 34 weeks of pregnancy
- 6-weeks postpartum
- 6-months postpartum
- 12-months postpartum
Women who report not smoking at any of the assessment points will be asked to provide a saliva sample for analysis of tobacco constituents and a breath sample to assess carbon monoxide. Bio-behavioral and pregnancy-specific factors will be used to triage women to one of four levels of stepped-care that includes:
- One in-person counseling session and at least one telephone session during pregnancy and from 6 to 11 telephone sessions over the first 9-months postpartum.
- Risk profiles will be used to match the intervention to each woman's needs.
- Women randomized to the control arm will receive the booklet, Forever Free for Baby and Me and usual prenatal and postpartum care.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Speak English
- •Registered for prenatal care
- •Have a history of smoking (defined as having smoked at least 100 cigarettes in their lifetimes and at least 5 cigarettes a day prior to becoming pregnant)
- •Will need to have been continuously abstinent from tobacco for at least 1 month prior to their risk assessment
- •Women will be eligible if they stopped smoking upon learning of their pregnancies and have been continuously abstinent (self-initiated quitters), or if they continued to smoke during the first few months of pregnancy but have been continuously abstinent from 24 to 28 weeks.
排除标准
- •Any women who stopped smoking and resumed by the 34-week risk assessment will be ineligible.
结局指标
主要结局
To assess the efficacy of an intervention in preventing or delaying postpartum smoking resumption among women who stop smoking during pregnancy.
时间窗: 12 months postpartum
次要结局
- To determine the association of baseline risk assessment variables with time to resumption.(12 months postpartum)