The Effect of a Zero Tolerance Program (SToP) Applied to Parents of Children at High Risk of Secondhand Tobacco Smoke Exposure on Child's Urine Cotinine Level According to Exposure Feedback: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Urine Cotinine Level
研究概览
简要总结
Although the ban on indoor smoking has greatly reduced secondhand smoke (SHS) exposure in public spaces, the home environment is still the primary source of exposure to SHS, particularly in children under the age of five. Although attempts are often made to prevent or reduce children's exposure to SHS, such as education, counseling, and exposure feedback to parents, exposure remains. Although using materials such as brochures, messages, posters and reminders that will minimize the harms such as protecting children from SHS will reduce the exposure, exposure continues in the long term.The aim of this study is to compare the effect of giving exposure feedback to the parents according to the zero tolerance program (SToP) on the urinary cotinine level of the children. In this study with active control group, single-blind (participant), randomized control, stratified block randomization (1:1) will be performed. Totally 58 participants including STOP intervention group (n:29) and the exposure feedback group (n:29), which is the active control group, were planned to be included in the study, which was planned to be conducted between January and September 2023. Cotinine-sensitive dipstick test kits will be used for the primary outcome (urine cotinine). Cotinine-sensitive dipstick test kit is a simple, cost-effective test to determine smoking status. It is an easy-to-read test strip that can be used with either a saliva or a urine sample. Secondary outcomes will be evaluated by information form on exposure to second-hand smoke, an attitude form on exposure to second-hand smoke, and a scale of beliefs towards third-hand smoke. This protocol will demonstrate whether SToP interventions, a sustainable program for children at high risk of secondhand tobacco exposure, are a viable intervention for parents on how to reduce 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
- Double (Participant, Outcomes Assessor)
盲法说明
Participating parents will not know which group they are. Also, when the data is analyzed by the statistician, she/he will not know which group it is.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents with children aged 5 and under, whose children are registered with the Family Health Center, and whose children are at high and very high risk of exposure to SHS according to the risk algorithm.
- •Parents' willingness to participate in the study
排除标准
- •Babysitter
- •Those who do not speak Turkish.
- •Parents of children with asthma will not be included on the grounds that it may be confusing as they may display more specific behavior.
研究组 & 干预措施
Zero (0) Tolerance Program Group
The intervention to this group consists of four parts.
- Urine Cotinine Feedback: Explaining what the cotinine-sensitive dipstick test kit score and color scale mean. Cotinine-sensitive dipstick test kit is a simple, cost-effective test to determine smoking status. It is an easy-to-read test strip that can be used with either a saliva or a urine sample.
- Giving reminder objects (Magnet, sticker): For example; at the entrance door of the house: "0 TOLERANCE" magnet to cigarettes; "No smoking in my home" label.
- Informative Materials (Information Notes and Brochures): Brochures on the harms of second-hand smoking (SHS) and third-hand smoking (THS), the diseases they cause, and how to protect them
- Informative Telephone Text Messages: Reminder phone messages related to SHS and THS
干预措施: Zero (0) Tolerance Program (SToP) (Behavioral)
Exposure Feedback Group
This group will receive only exposure feedback Urine Cotinine Feedback: Explaining what the cotinine-sensitive dipstick test kit score and color scale mean. Cotinine-sensitive dipstick test kit is a simple, cost-effective test to determine smoking status. It is an easy-to-read test strip that can be used with either a saliva or a urine sample.
干预措施: Exposure Feedback Group (Behavioral)
结局指标
主要结局
Urine Cotinine Level
时间窗: Change in Urine Cotinine Level at 3 and 6 months from baseline
The child's urine sample taken at any time will be analyzed with the cotinine-sensitive dipstick test kit to assess the urine cotinine level. Urine samples will be tested in accordance with the manufacturer's instructions. The test has over 99% sensitivity in detecting cotinine with a cut-off level of 200 ng/ml and a minimum detection time of 2-8 hours and a maximum detection time of 1-7 days. After the test is immersed in the urine collection container for 10 seconds, the result becomes clear within 5 minutes. If the test is negative, the control (C) and test (T) line appear. If the test is positive, only the control line (C) appears. If the C and T lines are not visible or the C line is visible, it means that the test is invalid. Each test sample will be read and recorded by two independent observers.
次要结局
- Beliefs About Third-Hand Smoke (THS) Scale(Change in beliefs level at 3 and 6 months from baseline)
- The Information Form on Exposure to Secondhand Smoke(Change in knowledge level at 3 and 6 months from baseline)
- Attitude Form on Exposure to Secondhand and Third hand Smoking(Change in attitude level at 3 and 6 months from baseline)
研究者
Sebahat Gozum
Prof.Dr.Sebahat Gozum
Akdeniz University