Early Life Intervention to Reduce Childrens Exposure to Second-Hand Smoke Using a Parent Coaching App
A Randomized Controlled Trial in Children Under 6 Years
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-05-06
160
Participants Needed
1
Research Sites
47 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate whether an eHealth application can help parents reduce their childrens exposure to second-hand tobacco smoke, which is linked to chronic inflammation and diseases like asthma. The trial involves children under 6 years old exposed to smoke at home and studies if the app lowers urinary cotinine levels, a marker of smoke exposure. The study is a single-blind randomized controlled trial assessing the feasibility and effectiveness of this intervention.
Participants are randomly assigned to two groups one group receives usual care plus access to a smartphone app designed to promote healthy behaviors through cognitive-behavioral methods and psychologist feedback over 20 weeks. The other group receives usual care and an informational flyer about second-hand smoke without app access. Assessments occur at the start, after 20 weeks of intervention, and again at a 6-month follow-up.
Throughout the study, researchers measure urinary cotinine levels to track smoke exposure, changes in parental smoking habits, and respiratory health in children. They also evaluate how well parents accept and use the app. Data collection includes baseline, post-intervention, and follow-up visits, with the total participation lasting almost a year to observe lasting effects and usability.
CONDITIONS
Brief Title
Early Life Intervention in Pediatrics Supported by E-health - SMOKE
Research Team
M
Matthias V. Kopp, Prof. Dr.
J
Julian Jakob, Dr.
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Child is exposed to second-hand smoke at home with at least one parent smoking
Parent or guardian speaks German
Parent or guardian has signed informed consent
Child lives in the same household as the participating parent
Referred by a healthcare professional such as a physician, midwife, or nurse
You will not qualify if you...
Participation in another study targeting similar outcomes
Participation in an active smoking cessation program
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 20 weeks
Participants receive treatment-as-usual (TAU). Parents in the intervention group additionally receive a smartphone app to promote healthy behavior through cognitive-behavioral coaching for 20 weeks, while the control group receives an information flyer.
Assessments at baseline and at 20 weeks post baseline
Follow-up
Duration - Approximately 6 months
Participants are assessed 6 months after the intervention to evaluate sustained effects on second-hand smoke exposure and related outcomes.
1 follow-up visit (in-person)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Early Life Intervention in Paediatrics Supported by E-Health (ELIPSE)-a coaching app for parents to reduce obesity and second-hand smoke exposure in children: study protocols for two parallel-group randomised controlled trials.