E-health intervention to reduce smoking exposure in children
Official title: 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
Run by Insel Gruppe AG, University Hospital Bern · NCT06311162 · Data updated 2026-11-12
This study is testing a new app for parents to help reduce secondhand smoke exposure for children under six years old and see if it improves their health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 5 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | May 7, 2024 |
| Main results expected | January 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT06311162 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children under six years old who are exposed to secondhand smoke at home.
✕Probably not a fit
Patients who are not exposed to secondhand smoke or are participating in other smoking cessation programs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of an eHealth application designed for parents to reduce secondhand smoke exposure in children under six years old. The study involves a single-blind randomized controlled trial with 160 participants, where children are assigned to either a control group or an intervention group receiving a lifestyle app for 20 weeks. The app promotes healthy behaviors through cognitive-behavioral strategies and is supported by structured feedback from a psychologist. The primary outcome is the reduction of urinary cotinine levels, indicating decreased secondhand smoke exposure, alongside secondary outcomes related to parental smoking habits and children's respiratory health.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce secondhand smoke exposure in children, leading to improved respiratory health and reduced risk of non-communicable diseases.
How similar studies have gone: Previous studies have shown promise in using eHealth interventions for smoking cessation and reducing secondhand smoke exposure, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Department of Paediatrics, Inselspital, Bern University Hospital
Bern, Switzerland Recruiting
Study contacts
- Principal investigator: Matthias V. Kopp, Prof. Dr. — Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland
- Study coordinator: Matthias V. Kopp, Prof. Dr.
- Email: matthias.kopp@insel.ch
- Phone: +41 31 66 4 13 51
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.