[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540001":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":42,"locations":52,"responsibleParty":75,"collaborators":77,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":46,"maxAge":90,"enrollmentInfo":91,"targetDuration":46,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":105,"overallStatus":55,"whyStopped":46,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group (Life-style app)","EXPERIMENTAL","Parents receive a smartphone app during the main intervention period of 20 weeks. The app (life-style app) aims to promote healthy behaviour through cognitive-behavioural impact factors.",[13],"Behavioral: Life-Style app",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","SHAM_COMPARATOR","The parents get an information sheet 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.",[19],"Other: Sham Comparator",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],[27],"Smartphone App",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"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.",[15],[33],"Flyer about second-hand smoke exposure",[35,39],{"name":36,"affiliation":37,"role":38},"Matthias V. Kopp, Prof. Dr.","Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":41,"role":38},"Michael Kaess, Prof. Dr.","Universitäre Psychiatrische Dienste Bern (UPD), University of Bern, Switzerland",[43,48],{"name":36,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","+41 31 66 4 13 51",null,"matthias.kopp@insel.ch",{"name":49,"role":44,"phone":50,"phoneExt":46,"email":51},"Julian Jakob, Dr.","+41 31 632 12 93","julian.jakob@insel.ch",[53],{"facility":54,"status":55,"city":56,"state":46,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Department of Paediatrics, Inselspital, Bern University Hospital","RECRUITING","Bern","3010","Switzerland","CH",{"type":61,"coordinates":62},"Point",[63,64],7.44744,46.94809,{"lat":64,"lon":63},[67,69,71,73],{"name":68,"role":44,"phone":50,"phoneExt":46,"email":51},"Julian Jakob, MD",{"name":70,"role":44,"phone":45,"phoneExt":46,"email":47},"Matthias V. Kopp, Prof, MD",{"name":68,"role":72,"phone":46,"phoneExt":46,"email":46},"SUB_INVESTIGATOR",{"name":74,"role":72,"phone":46,"phoneExt":46,"email":46},"Andrea Wyssen, PhD",{"type":76,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[78],{"name":79,"class":6},"University of Bern","100540001","early-life-intervention-in-pediatrics-supported-by-e-health---smoke-100540001",false,"NCT06311162","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","ELIPSE-II","Inclusion Criteria:\n\n* Age: younger than 6 years\n* Exposed to second-hand smoke at home (at least one parent smoking)\n* German speaking parent\n* All sex and ethnic backgrounds\n* Signed informed consent form from parent\n* Children live\u002Fgrow-up in the same household as the parental participant\n* Referred by a health care professional (e.g. physician, midwife, nurse, other professions)\n\nExclusion Criteria:\n\n* Participation in another study\u002Ftrial targeting similar outcomes\n* Participation in an active smoking cessation programme",true,"ALL","5 Years",{"count":92,"type":93},160,"ESTIMATED","INTERVENTIONAL",[96],"NA","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 .",[99,100,101,102,103,104],"Smoking Reduction","Asthma in Children","Wheezing","Non-Communicable Disease","Life Style","Behavior, Smoking",[106,107,108,109],"Secondhand smoke","Children","Prevention","eHealth","2026-04-30",{"date":112,"type":113},"2026-05-06","ACTUAL",{"date":115,"type":113},"2024-05-07",{"date":117,"type":93},"2028-12-31",{"name":5,"class":6},1]