RecruitingNot ApplicableNCT06311162

Early Life Intervention in Pediatrics Supported by E-health - SMOKE

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

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

160 participants

Start Date

May 7, 2024

Study Type

INTERVENTIONAL

Conditions

Life Style Asthma in Children Wheezing Smoking Reduction Non-Communicable Disease Behavior, Smoking

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 .

Eligibility

Max Age: 5 Years

Plain Language Summary

Simplified for easier understanding

This study tests a digital health (e-health) intervention designed to help parents quit smoking in order to reduce young children's exposure to secondhand smoke at home. Children under 6 who breathe in secondhand smoke are at higher risk for respiratory problems, ear infections, and developmental issues. **You may be eligible if...** - Your child is younger than 6 years old - At least one parent in the home smokes - You speak German - Your child lives in the same household as you - A healthcare professional (doctor, nurse, midwife, etc.) has referred you to this study **You may NOT be eligible if...** - You or your partner are already participating in another study targeting similar outcomes - You are already enrolled in an active smoking cessation program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALLife-Style app

The 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.

OTHERSham Comparator

The 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.