What is this study trying to find out about second-hand smoke exposure in children?

This study is evaluating whether an eHealth app for parents can reduce children's exposure to second-hand smoke by lowering urinary cotinine levels. Researchers want to see if the app is a feasible and effective way to promote healthier behaviors at home. The study is sponsored by Insel Gruppe AG, University Hospital Bern.

Who may be eligible for this smoking exposure clinical trial?

Children younger than 6 years who live in homes where at least one parent smokes may be eligible. The parent must speak German and provide consent. Children already in similar studies or whose parents are in a smoking cessation program are not eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this smoking exposure clinical trial?

Study-related care, including the use of the app and all trial visits, is provided at no cost. However, personal travel and other expenses are not always covered and may vary. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 0 - 5Years

All Genders

Healthy Volunteers

ID06311162

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

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-05-06

160

Participants Needed

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

Who Can Participate

Age: 0 - 5Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Child is younger than 6 years old
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

Research Team

Matthias V. Kopp, Prof. Dr.

Julian Jakob, Dr.

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