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临床试验/NCT01335178
NCT01335178已完成2 期

A Program to Protect Young Children From Tobacco Smoke Exposure

Tel Aviv University2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
29
试验地点
2
主要终点
Child exposure to tobacco smoke - hair nicotine

研究概览

简要总结

The goal of this research project is to develop and evaluate an intervention to reduce young child tobacco smoke exposure

详细描述

Goals The primary goal of this research is to develop and test a theory-based intervention which will reduce tobacco smoke exposure (TSE) of young children. A secondary goal is to increase knowledge of measurement of TSE in young children, and explore the relationship between early TSE, illness, and health care utilization. The study is being conducted in several stages: Developmental (Phase I), Pilot (Phase II), and Trial (Phase III). This registration pertains to Phase II of this trial.

Developmental Stage (Phase I)

This stage includes the following: Systematic reviews of the literature on the topics of encouraging i. parental cessation, ii.reducing child tobacco smoke exposure (TSE), and iii.reducing tobacco smoke air pollution in homes; consultations with experts worldwide; conduct of interviews with parents (n=65) and professionals (n=15) to understand parental perceptions of tobacco smoke exposure, and barriers to protection of children from TSE; and development of an initial intervention program. This stage draws on a social marketing approach and employs in-depth interviews to identify barriers to behavior change and relevant behavior-change recommendations, tailored to the intervention population, and to test the acceptability of program components.

Intervention Program

The intervention consisted of the following elements: (a) Three motivational interviews, scheduled for baseline, one month, and three months; (b) Feedback on air quality in the home (from a Sidepak and/or a Dylos monitoring device, and from passive air nicotine dosimeters); (c) Feedback on child's exposure via hair samples analyzed for nicotine; (d) a website designed especially for the project [22];and (e) various self-help materials, including a booklet, a magnet about TSE, and air fresheners.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
— 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • At least one parent was a current smoker. The child was of the appropriate age (<8 years of age). The child had sufficient hair growth for hair samples. A parent gave consent for participation in the research. The parent can communicate in Hebrew.

排除标准

  • One of above conditions not met

结局指标

主要结局

Child exposure to tobacco smoke - hair nicotine

时间窗: Baseline, 6 months post-intervention

Child exposure to tobacco smoke as assessed by hair nicotine level

次要结局

  • Child exposure to tobacco smoke - parental report(Baseline, 6 months post-intervention)
  • Child health status(Baseline, 6 months post-intervention (continuous))
  • Respirable Small Particle (RSPs - PM2.5) level in home(Baseline, 1 month post-intervention)
  • Air nicotine(Baseline, 6 months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Rosen

Chair, Dept. of Health Promotion, School of Public Health, Sackler Faculty of Medicine

Tel Aviv University

研究点 (2)

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