[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564245":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":57,"collaborators":59,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":18,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":18,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Deutsches Herzzentrum Muenchen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Digital Health Intervention","EXPERIMENTAL","Children and their guardians are given access to a 12-week digital platform with content to improve their lifestyle.\n\nPhysical activity is monitored with a Garmin Vivofit Jr. 2.",[13],"Behavioral: Digital Health Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","During 12-week control period participants receive no access the digital platform. Physical activity is monitored with a Garmin Vivofit Jr. 2.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","Access to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour.",[9],[25],{"name":26,"affiliation":27,"role":28},"Jan Müller, Prof. Dr.","Technical University of Munich, Chair of preventive perdiatrics","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","‭0176 21149304‬","j.mueller@tum.de",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Isabel Uphoff, M.Sc.","01639104022","uphoff@dhm.mhn.de",[39],{"facility":40,"status":41,"city":42,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Department of Paediatric Cardiology and Congenital Heart Defects, German Heart Center of the State Bavaria (Munich), Technical University of Munich (TUM)","RECRUITING","München","Germany","DE",{"type":46,"coordinates":47},"Point",[48,49],13.31243,51.60698,{"lat":49,"lon":48},[52],{"name":53,"role":31,"phone":54,"phoneExt":55,"email":56},"Jan Müller, PhD","+4989289","24574","j.mueller@tum.de",{"type":58,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[60,62],{"name":61,"class":6},"Technical University of Munich",{"name":63,"class":64},"Stiftung KinderHerz Deutschland gGmbH","UNKNOWN","100564245","digital-health-promotion-for-children-with-congenital-heart-disease-and-their-guardians-100564245",false,"NCT06626672","Digital Health Promotion for Children With Congenital Heart Disease and Their Guardians","Digital Lifestyle Intervention to Promote Physical Activity, Nutrition, and Health Literacy in Children With Congenital Heart Disease and Their Guardians","Inclusion Criteria:\n\n* Ages 8-14 years\n* Presence of a congenital heart defect (must be moderate or complex according to ACC criteria)\n* NYHA Class I or II\n* Presence of written informed consent\n\nExclusion Criteria:\n\n* Cognitive impairments that inhibit patients from understanding the tasks\n* No sports clearance by paediatric cardiologists","ALL","8 Years","14 Years",{"count":76,"type":77},60,"ESTIMATED","INTERVENTIONAL",[80],"NA","Congenital heart disease (CHD) affects approximately 1% of live births, and children with CHD often fail to meet WHO physical activity guidelines. Digital interventions to promote physical activity in CHD patients are limited. This study will develop and test a 12-week digital lifestyle intervention for children (ages 8-13) and their guardians, using a Garmin Vivofit Jr. 2 wearable to continuously monitor physical activity (PA). We will assess its impact on children's moderate to vigorous intensity physical activity (MVPA), daily activity (steps per day), quality of life, nutrition, and health literacy, as well as the quality of life and health literacy of their parents.",[83,84],"Congenital Heart Disease","Pediatric ALL",[83,86,87,88,89,90,91,92,93,94],"Congenital Heart Defect","Child","Physical Activity","Exercise","MVPA","Digital Health","Telemedicine","Health literacy","Quality Of Life","2025-01-27",{"date":97,"type":98},"2025-01-29","ACTUAL",{"date":100,"type":98},"2024-10-01",{"date":102,"type":77},"2026-02",{"name":5,"class":6},1]