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临床试验/NCT00821639
NCT00821639已完成不适用

Reduction of Secondhand Smoke Exposure in Healthy Infants

Tehran University of Medical Sciences2 个研究点 分布在 2 个国家目标入组 130 人开始时间: 2008年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
2
主要终点
Infant's urinary cotinine levels

研究概览

简要总结

The purpose of this study is to assess the effects of a health center based counselling method for the prevention of infant exposure to secondhand smoke.

详细描述

This study, a two group randomised controled trial, investigates whether an intervention for parents would persuade them to enforce smoking bans inside the home and in other locations. A total of 130 parents with children aged 12 months or younger will be recruited. Each group (n=65) will complete a baseline and follow up questionnaire. Urine samples from the infants will be collected to measure the amount of cotinine, a metabolite of nicotine. The parent-report and infant's urinary cotinine measures will be obtained at baseline and at a 3-month follow up. In the intervention group, parents will be given three counselling sessions. For mothers, one being face to face and two telephone counselling and for fathers we will conduct three telephone counselling. The control group receives no intervention. Both groups will also complete a Fagerstrom test for nicotine dependence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Families with healthy infants under 12 months of age
  • The infant resides with at least one smoking parent
  • Parents being able to speak Persian and having a telephone

排除标准

  • Parent(s) reporting consumption of other addictive substances
  • Parent(s) in smoking cessation treatment

结局指标

主要结局

Infant's urinary cotinine levels

时间窗: At baseline and at a 3-month follow-up

次要结局

  • Home smoking bans status, Car smoking bans status, Parental cigarette consumption(At baseline and at a 3-month follow-up)

研究者

申办方类型
Other

研究点 (2)

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