Early Life Intervention in Pediatrics Supported by E-health - SMOKE

NCT06311162 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-06

No results posted yet for this study

Summary

Unrestricted parental smoking habits are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of non-communicable diseases (NCDs). Exposure to secondhand tobacco smoke in early life contributes to the development of specific NCDs in children, i.e. asthma. Early preventive measures to improve lifestyle behavior in parents are therefore of utmost importance. The aim of ELIPSE-II is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering levels of urinary cotinine as a measure of second-hand smoke exposure in their children .

Conditions

  • Smoking Reduction
  • Asthma in Children
  • Wheezing
  • Non-Communicable Disease
  • Life Style
  • Behavior, Smoking

Interventions

BEHAVIORAL

Life-Style app

The modules of the Life-Style app are introduced and unlocked sequentially during the first weeks of the intervention phase. Afterwards the modules are fully available. Duration and frequency of app-use is not limited. The parents are accompanied by a coach through the app, who gives regular structured feedback and individual inputs. The coach has access to all data collected in the app.

OTHER

Sham Comparator

The parents get a flyer with information on second-hand smoke exposure and references to smoking cessation programs, and do not have an active app during the main intervention period.

Sponsors & Collaborators

  • University of Bern

    collaborator OTHER
  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Matthias V. Kopp, Prof. Dr. · Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland

  • Michael Kaess, Prof. Dr. · Universitäre Psychiatrische Dienste Bern (UPD), University of Bern, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-07
Primary Completion
2028-01-31
Completion
2028-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06311162 on ClinicalTrials.gov