The Effectiveness of High and Low Intensity Intervention for Smoking Cessation During Pregnancy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- Participants' Smoking Status
研究概览
简要总结
The aim of this clinical trial is to test whether offering pregnant smokers a high intensity intervention for smoking cessation increases the rate of smoking cessation at the third trimester of pregnancy, compared to low intensity intervention for smoking cessation that is the usual care, control condition.
详细描述
This is a randomized controlled trial that compares the efficacy of a proactive pregnancy-tailored high intensity intervention for smoking cessation, with a usual care low intensity intervention, that is the control condition.
Intervention group participants will receive a high intensity intervention, which includes: 30 minutes of cognitive-behavioural intervention delivered by a trained health care professional through out the first 24 weeks of gestation and a self-help manual especially tailored for smoking cessation during pregnancy. Control group participants will receive 5 minutes of low intensity intervention.
Participants' smoking status will be biochemically validated with urine cotinine and nicotine both at the baseline and at the 32nd week of gestation, expired carbon monoxide (CO) will be measured only at the baseline. After childbirth the infants' birth weight, the premature birth and any other complications in pregnancy and childbirth will be recorded. No medication is going to be used.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women
- •current cigarette smoker (smoked >5 cigarettes in the past 7 days)
- •18 years old or older
排除标准
- •More than 24 weeks' gestation at study entry
- •No telephone access
- •Not planning to live in Athens for 1 year
- •Unable to read and speak Greek
- •Alcoholics
- •Use of drug substances
- •Depression
结局指标
主要结局
Participants' Smoking Status
时间窗: around the 32nd week of gestation.
participants' smoking status was validated by urine cotinine and urine nicotine
The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention.
时间窗: At the baseline and at the 32nd week of gestation
The basic primary outcomes of the study present the levels of urine cotinine before and after intervention separately for each group according to the cut of point that is used for the separation of active from passive smoking ,when urine cotinine ≤80ng/ml: there is biochemically validated smoking cessation.
次要结局
- Birth Weight(After child birth)
- Days of Prematurity of Birth(After child birth)
研究者
PANAGIOTIS BEHRAKIS
PROFESSOR OF NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS.
Hellenic Anticancer Society