RecruitingNot ApplicableNCT06311162

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

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

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

160 participants

Start Date

May 7, 2024

Study Type

INTERVENTIONAL

Conditions

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

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 .

Eligibility

Max Age: 5 Years

Inclusion Criteria7

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 Criteria2

Participation in another study/trial targeting similar outcomes
Participation in an active smoking cessation programme

Interventions

BEHAVIORALLife-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.

OTHERSham 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.