Telephone Counseling for Pregnant Smokers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,173
- 试验地点
- 2
- 主要终点
- 30 days prolonged abstinence
研究概览
简要总结
This purpose of the study was to investigate the efficacy of telephone counseling to help pregnant women quit smoking. The investigators tested two hypotheses: 1) telephone counseling increases the overall cessation rate during pregnancy, and 2) the counseling effects can be maintained postpartum.
详细描述
Smoking during pregnancy increases the risk of low birth weight, premature delivery, fetal and infant death, and children's developmental problems. It is also associated with significant economic costs. Telephone cessation quitlines have been suggested as one good way to reach pregnant smokers.
This randomized controlled trial was embedded into a free statewide telephone cessation quitline in California. The primary component of the intervention was telephone counseling using a structured protocol developed specifically for the pregnant population. The counseling consisted of nine counseling sessions.
A secondary component of the intervention was the mailed materials. Following enrollment in the study all subjects (control and intervention) received a self-help quit kit for pregnant smokers and fact sheets on second-hand smoke and additional tips for quitting while pregnant. Subjects in the counseling intervention group received five additional mailings. These mailings were designed to remind them of their commitment to quitting and of the presence of counseling support if they needed help.
Prior to 36 weeks gestation (in the third trimester), 2-months postpartum, and 6-months postpartum we conducted a brief telephone survey to assess smoking status. The information obtained allowed us to determine 30-day prolonged abstinence rates.
Prior to 36 weeks gestation (in the third trimester), the investigators sent a kit and requested saliva samples be mailed back to biochemically verify smoking status by testing for cotinine and nicotine byproducts.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Current smoker willing to quit within one month
- •Recent quitters
- •First time quitline caller
- •Less than 27 weeks gestation
- •English and/or Spanish speaking
- •Valid phone number
- •Valid address
- •Gave consent to participate in study and evaluation
排除标准
- •Active psychiatric disorder
- •Substance or alcohol abuse
- •Had been in recovery from alcohol or other substances for less than 6 months
- •Planned to use pharmacotherapy
- •Insufficient contact information
结局指标
主要结局
30 days prolonged abstinence
时间窗: 6-months postpartum
Conducted a brief telephone survey to assess smoking status. The information obtained allowed us to determine 30-day prolonged abstinence rates.
次要结局
- Percentage of smokers making a 24-hour quit attempt(6-months postpartum)
- Relapse curve based on quit attempt(Seven months post enrollment)
- 7-day cotinine verified abstinence(<36 weeks gestation)
- 30 days prolonged abstinence(2-months postpartum)
研究者
Shu-Hong Zhu
Professor
University of California, San Diego