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 .
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
Participation in another study/trial targeting similar outcomes
Participation in an active smoking cessation programme
Parallel
Life-Style app
BehavioralThe modules of the Life-Style app are introduced and unlocked sequentially during the first weeks of the intervention phase. Afterwards the modules are fully available. Duration and frequency of app-use is not limited. The parents are accompanied by a coach through the app, who gives regular structured feedback and individual inputs. The coach has access to all data collected in the app.
Sham Comparator
Other interventionThe parents get a flyer 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.
Change from baseline in urinary levels of cotinine in children
Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine
Change from baseline in urinary levels of cotinine in children
Change in exposure to second-hand smoke exposure assessed by urinary levels of cotinine
Change from baseline in protective measures taken by parents to protect children from second-hand smoke exposure
Parents are asked (using a questionnaire) about the measures taken to protect children from second-hand smoke exposure at baseline, during the intervention, postintervention and follow-up. Protective measures assessed include washing hands, smoking outside (including not smoking in the car), changing clothes after smoking). The questionnaire consists of five items (protective measures) with a score ranging from 1 to 5. Score 5 means a better result.
Acceptance and usability of the app (parent reported outcome)
The usability of the app is assessed using the eHealth App Usability Questionnaire (MAUQ). The questionnaire measures usability on three subscales (ease of use, Interface and satisfaction, usefulness). The MAUQ questionnaire consists of 18 items with a score ranging from 1 to 7. Score 7 means a better result.
Acceptance of the app
The acceptance of the app is measured by means of dropout rate.
Usability of the app
The usability of the app is measured by means of how often and how long the parents use the app.
Number of episodes of airway disease in children
Parents are asked to report any event of airway disease (including any type of upper or lower respiratory tract infection; e.g. otitis media, rhinitis, pharyngitis, acute or chronic bronchitis, protracted bacterial bronchitis, chronic cough, pneumonia).
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Insel Gruppe AG, University Hospital Bern
Lead sponsor
University of Bern
Collaborator
