Efficacy of Proactive Telephone Counseling for Pregnant Smokers Enrolled in a Managed Care Organization
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 434
- 试验地点
- 3
- 主要终点
- Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
研究概览
简要总结
The principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a "best practice" control condition.
详细描述
A randomized controlled trial compared the efficacy of a proactive pregnancy-tailored telephone-delivered smoking cessation counseling program with a "best practice" brief counseling control condition among pregnant women referred by prenatal care providers and a managed care plan in Massachusetts. Intervention group patients received up to 105 min of cognitive-behavioral counseling delivered in a motivational interviewing style by trained counselors throughout pregnancy and for 2 months postpartum. Control group patients received 5 minutes of brief counseling at 1 telephone call. All participants were mailed written self-help smoking cessation material tailored to pregnancy. The primary outcome measure was cotinine-validated tobacco abstinence at the end of pregnancy. Secondary outcomes were cotinine-validated abstinence at 3 months postpartum and self-reported significant (>50%) reduction in daily cigarette use.
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
- 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
- 否
入选标准
- •Pregnant women
- •current cigarette smoker (smoked >1 cigarette in the past 7 days)
- •18 years old or older
- •Willing to consider altering their smoking behavior during their pregnancy
排除标准
- •More than 26 weeks' gestation at study entry
- •No telephone access
- •Not planning to live in New England for 1 year
- •Unable to read and speak English
结局指标
主要结局
Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
次要结局
- Biochemically-validated 7-day point prevalence tobacco abstinence at 3 months postpartum
- Self-reported significant (>50%) reduction in tobacco use
- Quit attempt of >24 hours duration from enrollment to end of pregnancy
