Community Outreach and Biomarker Feedback for Smoke-Free Homes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Change in Home Secondhand Smoke levels
研究概览
简要总结
Smoking is widely accepted to cause an increase in an individual's likelihood of developing cancer and heart disease. The effects of tobacco smoke are not limited to smokers. Secondhand smoke inhaled by a non-smoker has also been associated with the development of several illnesses. This study focuses on learning how to make your home smoke-free.
详细描述
This study will be conducted in two phases. Phase 1 will be qualitative focus groups/pilot study with the purpose to develop a motivationally enhanced biomarker feedback counseling protocol and all printed materials to be used in Phase 2. After investigators develop a good working treatment protocol, an active intervention in smoking homes who live with a child in their home will be carried out.
Those randomized to the Control Group will receive health education in the form of brochures detailing the health effects of secondhand smoke and how to make their home smoke free. Participants randomized to the Treatment Group will receive tobacco-specific biomarker feedback and personalized motivationally enhanced counseling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Smoked ≥ 1 cigarettes per day for at least the past 6 months
- •Smoked on 20 days or more in the last month
- •Smoking status confirmed via cotinine verification strips
- •Resides with a child ≤ 10 years of age in the role of the child's parent or caregiver
- •Will agree to provide a urine sample at study enrollment
- •Will also agree to the child providing a urine sample at study enrollment and at follow-up visits (for children who are not toilet trained, a diaper sample will be collected in lieu of the urine sample)
- •Has a home address
- •Has a functioning home phone or cell phone
- •Provides written informed consent
- •Inclusion criteria (child):
- •< or = 10 years of age
- •Non-smoker -no cigarette use within prior 30 days to enrollment; however experimentation with smoking (a puff) will not exclude the child
- •Lives in the primary home with the adult study participant at least 5 days a week
排除标准
- •Current or past 7 day use of Nicotine Replacement Therapy (NRT) or pharmacotherapy for smoking cessation
- •Planning to move outside of Minnesota within the next 3 months
- •Have complete home smoking restrictions currently in place verified by the nicotine dosimeter
- •Currently pregnant
研究组 & 干预措施
Control Group - Health Education
This group is provided with information regarding secondhand smoke and creating a healthy home environment.
干预措施: Brochure (Behavioral)
Treatment Group - Counseling
This group is provided with biomarker feedback on child exposure to secondhand smoke. Active participants receive 5 counseling sessions from a trained research counselor; 3 sessions in the home and 2 by phone. The counseling sessions focus on changing smoking behaviors and/or other behaviors that impact smoking.
干预措施: Counseling (Behavioral)
结局指标
主要结局
Change in Home Secondhand Smoke levels
时间窗: From Baseline to Week 26 Follow-Up
Measured by nicotine dosimeter - a passive "badge" hung in the home that measures free floating airborne nicotine particles.
次要结局
- Comparison of Child Cotinine Levels in Urine(From Baseline to Week 26 Follow-Up)
- Comparison of Questionnaire Results(Baseline, Week 16 and Week 26)