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临床试验/NCT00181909
NCT00181909已完成3 期

Efficacy of Proactive Telephone Counseling for Pregnant Smokers Enrolled in a Managed Care Organization

Massachusetts General Hospital3 个研究点 分布在 1 个国家目标入组 434 人开始时间: 2001年9月最近更新:
适应症

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

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

研究者

申办方类型
Other

研究点 (3)

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