Actively Recruiting
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-05-06
160
Participants Needed
1
Research Sites
47 weeks
Total Duration
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
U
University of Bern
Collaborating Sponsor
This research aims to evaluate whether an eHealth application can help parents reduce their children's 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
Early Life Intervention in Pediatrics Supported by E-health - SMOKE
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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)
Total: 1 location
1
Department of Paediatrics, Inselspital, Bern University Hospital
Bern, Switzerland, 3010
Actively Recruiting
M
Matthias V. Kopp, Prof. Dr.
J
Julian Jakob, Dr.
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Alexander Koch, Andrea Wyssen, Clemens Haupt...
https://pubmed.ncbi.nlm.nih.gov/41254719