Early Life Intervention in Pediatrics Supported by E-health (ELIPSE II): Coaching Parents to Lower Second-hand Smoke Exposure in Children A Single-blind Randomized Controlled Parallel-group Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change from baseline in urinary levels of cotinine in children
研究概览
简要总结
Unrestricted parental smoking habits are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of non-communicable diseases (NCDs). Exposure to secondhand tobacco smoke in early life contributes to the development of specific NCDs in children, i.e. asthma. Early preventive measures to improve lifestyle behavior in parents are therefore of utmost importance. The aim of ELIPSE-II is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering levels of urinary cotinine as a measure of second-hand smoke exposure in their children .
详细描述
ELIPSE-II represents a single-blind randomized controlled parallel-group clinical trial. In total, 160 children, <6 years of age with exposure to second-hand smoke at home will be included. Children will be recruited at the children's university hospital and in private practices in Bern, and randomly (1:1) assigned to a control and intervention group.
All participants receive treatment-as-usual (TAU), parents of participants in the intervention group additionally receive a smartphone application (lifestyle app) for 20 weeks. The app aims to promote healthy behavior through cognitive-behavioral impact factors (i.e., psychoeducation, goal setting), that are applied by a psychologist via structured feedback. Single-blinded assessments will be conducted at baseline, following the intervention period of 20 weeks, and at 6-month follow-up after the end of the intervention. The primary endpoint is reduction of exposure to second-hand smoke exposure assessed by urinary levels of cotinine. Secondary endpoints in ELIPSE-II include changes in parental smoking habits and effects of the intervention on infants' respiratory health. A further endpoint is acceptance and usability of the app.
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 (Care Provider, Investigator)
盲法说明
The study team members who are conducting assessments on the participants remain blinded to the treatment allocation.
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: younger than 6 years
- •Exposed to second-hand smoke at home (at least one parent smoking)
- •German speaking parent
- •All sex and ethnic backgrounds
- •Signed informed consent form from parent
- •Children live/grow-up in the same household as the parental participant
- •Referred by a health care professional (e.g. physician, midwife, nurse, other professions)
排除标准
- •Participation in another study/trial targeting similar outcomes
- •Participation in an active smoking cessation programme
研究组 & 干预措施
Treatment group (Life-style app)
Parents receive a smartphone app during the main intervention period of 20 weeks. The app (life-style app) aims to promote healthy behaviour through cognitive-behavioural impact factors.
干预措施: Life-Style app (Behavioral)
Control group
The parents get an information sheet with information on second-hand smoke exposure and references to smoking cessation programs, and do not have an active app during the main intervention period.
干预措施: Sham Comparator (Other)
结局指标
主要结局
Change from baseline in urinary levels of cotinine in children
时间窗: At 48 weeks after baseline (Follow-Up)
Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine
Change from baseline in urinary levels of cotinine in children
时间窗: At 22 weeks after baseline (Post intervention)
Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine
次要结局
- Change from baseline in protective measures taken by parents to protect children from second-hand smoke exposure(During intervention (week 2-22), post intervention (week 22-23) and follow-up (week 48-49))