跳至主要内容
临床试验/NCT02500238
NCT02500238已完成不适用

Comparison of Smoking and Vaping in Families

University of Florida2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2015年11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
44
试验地点
2
主要终点
Assessment of lung function

研究概览

简要总结

Electronic cigarette use may be less harmful than cigarettes in adults, however, limited data exists examining passive electronic cigarette exposure and child health outcomes. The current study seeks to compare health-related outcomes among youth who reside with non-smokers, cigarette smokers, and electronic cigarette users. The investigators propose to conduct a small pilot study with 30 youth, ages 6-17 and a caregiver. Three groups of 10 parent-child dyads will be recruited: 1) control group: parents who are non-smokers/non-vapers, 2) smoking group: parents who are exclusive cigarette smokers, and 3) vaping group: parents who are exclusively ECIG users. Groups will be compared across the following variables: child lung function and biomarkers of nicotine.

详细描述

The current study seeks to compare health-related outcomes among youth who reside with non-smokers, cigarette smokers, and electronic cigarette users.

Control Group: will consist of participants ages 6 - 17 who live in a home with adults who do not smoke. A brief breathing test will verify a non-smoker and/or are not around a certain amount of smoke in the environment (live with a smoker). The participant will be asked to complete a series of brief questionnaires that asks about basic demographic information, medical history, and that asks about their smoking history. The participant's will also be asked to complete two 5 minute breathing tests, provide a sample of saliva, a urine sample, and have their toe nails clipped.

Vaping Group: will consist of participants ages 6 -17 who live in a home with adults who currently use electronic cigarettes. A brief breathing test will verify a non-tobacco smoker and/or are not around a certain amount of smoke in the environment (live with a tobacco smoker). The participant will be asked to complete a series of brief questionnaires that asks about basic demographic information, smoking or vaping history and patterns of use, and medical history. The participant will be asked to complete two 5 minute breathing tests, provide a sample of saliva, a urine sample, and have their toe nails clipped.

Smoking Group: will consist of participants ages 6 - 17 who live in a home with adults who currently smoke cigarettes. Participants will then be asked to complete a series of brief questionnaires that asks about basic demographic information, smoking or vaping history and patterns of use, and medical history. The participant will also be asked to complete two 5 minute breathing tests, provide a sample of saliva, a urine sample, and have their toe nails clipped.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • For the control group the caregiver must self-report:
  • never smoking or not smoking for at least the past 12 months;
  • that no one living in the home is a current smoker or has smoked in the home for the past 6 months; and
  • have a breath carbon monoxide reading of ≤ 6ppm.
  • For the smoking group caregivers must:
  • smoke at least 10 cigarettes per day for the past year;
  • indicate that they smoke in the car or home ≥ 3 times per week; and
  • do not use non-cigarette tobacco (e.g., cigars, chewing tobacco).
  • For the vaping group caregivers must:
  • exclusively use EC for the past 3 months (no cigarette or other tobacco use); and
  • no one living in the home is a current tobacco smoker or has smoked in the home for the past 6 months; and
  • have a breath carbon monoxide reading of ≤ 6ppm.

排除标准

  • 未提供

结局指标

主要结局

Assessment of lung function

时间窗: Day 1

Child lung function will be measured at the study visit. Forced expiratory volume in the first second will be assessed.

次要结局

  • Assessment of cotinine in saliva(Day 1)
  • Assessment of cotinine in urine(Day 1)
  • Assessment of nicotine in toenail clippings(Day 1)
  • Assessment of tobacco specific nitrosamine in toenail clippings(Day 1)
  • Assessment of cotinine in toenail clippings(Day 1)
  • Assessment of tobacco specific nitrosamine in urine(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验