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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Smoking Reduction
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Change from baseline in urinary levels of cotinine in children
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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 .
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •Participation in another study/trial targeting similar outcomes
- •Participation in an active smoking cessation programme
Outcomes
Primary Outcomes
Change from baseline in urinary levels of cotinine in children
Time Frame: At 48 weeks after baseline (Follow-Up)
Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine
Secondary Outcomes
- 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))