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RECRUITING
NCT06311162
NA

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

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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 .

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

Key Details

Gender

All

Age Range

Any - 5 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2024-05-07

Completion Date

2028-07-31

Last Updated

2024-05-16

Healthy Volunteers

Yes

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.

Locations (1)

Department of Paediatrics, Inselspital, Bern University Hospital

Bern, Switzerland