E-health intervention to reduce smoking exposure in children
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | N/A to 5 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT06311162 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children under six years old who are exposed to secondhand smoke at home.
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.
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 performed: Previous studies have shown promise in using eHealth interventions for smoking cessation and reducing secondhand smoke exposure, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Bern
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.