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临床试验/NCT01630356
NCT01630356已完成不适用

Monitoring Secondhand Smoke Exposure in Buildings in Armenia: Controlled Trial

Johns Hopkins Bloomberg School of Public Health2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
2
主要终点
change in child's hair nicotine concentration

研究概览

简要总结

This study was designed to test the hypothesis whether a novel intervention that uses motivational interviewing along with immediate feedback and follow-up counseling calls is effective in educating the household members about the health hazards of smoking and secondhand smoke exposure and reducing children exposure to secondhand smoke at households in Armenia.

The study was a randomized control trial with two arms: intervention and control groups.

The sample population for the study included households with a non-smoking mother and at least one child 2 to 6 years of age residing with at least one daily smoker. The study team recruited the households through pediatrician's offices in polyclinics (primary healthcare facilities) utilizing multistage random sampling. Trained interviewers made two baseline (one week apart) and two 4-month follow-up household visits to conduct measurements, interviews and intervention. Measurements included surveys, air nicotine monitoring in homes and hair samples from children to assess changes in nicotine concentration over time.

SHS concentration was estimated by sampling vapor-phase nicotine using a filter badge treated with sodium bisulfate. Airborne nicotine monitors were used in all homes to measure SHS concentration at baseline and 4 month follow-up. At least one monitor was used in each home, preferably in the main room in which the family congregates.

Personal exposure to SHS in 2-6 years old children was assessed using biological samples of hair. A small sample of hair (approximately 30 - 50 strands, 2-3 cm) was cut near the hair root from the back of the scalp where there is the most uniform growth pattern between individuals which minimizes the variability of the results.

The intervention included an in-person counseling session with distribution of a tailored educational brochure and demonstration/feedback measurement of indoor PM2.5 (at second baseline visit); it also included one and two months follow-up counseling calls. The control group received only a brief educational leaflet on the hazards of second-hand smoke exposure.

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
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least one child 2 to 6 years of age
  • Non-smoking mother
  • At least one daily smoker
  • Child's exposed to second smoke of at least 1 cigarette per day

排除标准

  • Mother's pregnancy
  • Child's hair less than 2 cm in length after stretching out
  • Residing out of Yerevan

结局指标

主要结局

change in child's hair nicotine concentration

时间窗: baseline and 4-month follow-up

change in air nicotine concentration

时间窗: baseline and 4-month follow-up

次要结局

  • change in the respondents' knowledge on hazards of smoking and secondhand smoke(baseline and 4-month follow-up)
  • change in frequency of smoking in the presence of the child(baseline and 4-month follow-up)
  • change in household smoking restrictions(baseline and 4-month follow-up)

研究者

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

Frances Stillman

Ed. D, Johns Hopkins Bloomberg School of Public Health, Department of Health, Behavior and Society

Johns Hopkins Bloomberg School of Public Health

研究点 (2)

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