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Early Life Intervention in Pediatrics Supported by E-health - SMOKE — ELIPSE-II  

Asthma in Children Clinical Trial

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

Clinical Trial 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 .

Clinical Trial Description

ELIPSE-II represents a single-blind randomized controlled parallel-group clinical trial. In total, 160 children, <6 years of age with exposure to second-hand smoke at home will be included. Children will be recruited at the children's university hospital and in private practices in Bern, and randomly (1:1) assigned to a control and intervention group. All participants receive treatment-as-usual (TAU), parents of participants in the intervention group additionally receive a smartphone application (lifestyle app) for 20 weeks. The app aims to promote healthy behavior through cognitive-behavioral impact factors (i.e., psychoeducation, goal setting), that are applied by a psychologist via structured feedback. Single-blinded assessments will be conducted at baseline, following the intervention period of 20 weeks, and at 6-month follow-up after the end of the intervention. The primary endpoint is reduction of exposure to second-hand smoke exposure assessed by urinary levels of cotinine. Secondary endpoints in ELIPSE-II include changes in parental smoking habits and effects of the intervention on infants' respiratory health. A further endpoint is acceptance and usability of the app. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06311162
Study type Interventional
Source Insel Gruppe AG, University Hospital Bern
Contact Matthias V. Kopp, Prof. Dr.
Phone +41 31 66 4 13 51
Email matthias.kopp@insel.ch
Status Recruiting
Phase N/A
Start date May 7, 2024
Completion date July 31, 2028
View Details
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