protocolSection identificationModule nctId: NCT06311162, orgStudyIdInfo id: 2023-01615, briefTitle: Early Life Intervention in Pediatrics Supported by E-health - SMOKE, acronym: ELIPSE-II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2027-08-31, completionDateStruct date: 2028-07-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Insel Gruppe AG, University Hospital Bern, class: OTHER, collaborators name: University of Bern, descriptionModule briefSummary: 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 ., conditionsModule conditions: Smoking Reduction, conditions: Asthma in Children, conditions: Wheezing, conditions: Non-Communicable Disease, conditions: Life Style, conditions: Behavior, Smoking, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Single-blind randomized controlled parallel-group clinical trial, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: The study team members who are conducting assessments on the participants remain blinded to the treatment allocation., whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Life-Style app, interventions name: Sham Comparator, outcomesModule primaryOutcomes measure: Change from baseline in urinary levels of cotinine in children, primaryOutcomes measure: Change from baseline in urinary levels of cotinine in children, secondaryOutcomes measure: Change from baseline in protective measures taken by parents to protect children from second-hand smoke exposure, otherOutcomes measure: Acceptance and usability of the app (parent reported outcome), otherOutcomes measure: Acceptance of the app, otherOutcomes measure: Usability of the app, otherOutcomes measure: Number of episodes of airway disease in children, otherOutcomes measure: Frequency of inhalant medications or antibiotics required for airway disease in children, otherOutcomes measure: Amount of inhalant medications or antibiotics required for airway disease in children, otherOutcomes measure: Number of episodes of severe airway disease in children requiring hospitalization, otherOutcomes measure: Change from baseline in parental smoking intensity (number of cigarettes smoked per day), eligibilityModule sex: ALL, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Department of Paediatrics, Inselspital, Bern University Hospital, city: Bern, zip: 3010, country: Switzerland, contacts name: Julian Jakob, MD, role: CONTACT, phone: +41 31 632 12 93, email: julian.jakob@insel.ch, contacts name: Matthias V. Kopp, Prof, MD, role: CONTACT, phone: +41 31 66 4 13 51, email: matthias.kopp@insel.ch, contacts name: Julian Jakob, MD, role: SUB_INVESTIGATOR, contacts name: Andrea Wyssen, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 46.94809, lon: 7.44744, hasResults: False