[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564245":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":36,"studyPopulation":36,"armGroups":44,"interventions":55,"overallOfficials":60,"centralContacts":65,"locations":74,"responsibleParty":93,"collaborators":95,"id":101,"slug":36,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":36,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":36,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":77,"whyStopped":36,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Deutsches Herzzentrum Muenchen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Physical activity","Physical activity is objectively assessed with the wrist worn wearable \"Garmin vivofit jr. 2\". Daily physical activity is measured on the basis of active minutes in moderate-to-vigorous intensity.","12 weeks",[14,17,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":12},"Daily step count","Children's daily step count is objectively assessed using the wrist-worn wearable device, Garmin Vivofit Jr. 2.",{"measure":18,"description":19,"timeFrame":20},"Health-related quality of life","Children's health-related quality of life is self-assessed via the KINDL® questionnaire. The KINDL® is a generic instrument for assessing health-related quality of life in children and adolescents. The KINDL® is a short, methodologically tested and flexible measurement instrument consisting of 24 questions on the six areas of body\u002Fphysis, feelings\u002Fpsychology, self-assessment, family, friends and school.","Baseline, after 6 weeks, after 12 weeks",{"measure":22,"description":23,"timeFrame":20},"Physical Activity Health Literacy","Physical Activity Health Literacy Scale for Children (PAHL-C) evaluates children's self-reported knowledge and understanding of physical activity and its benefits through an 8-question scale.",{"measure":25,"description":26,"timeFrame":20},"Nutritional Health Literacy","The Nutrition Health Literacy Scale for Children (NHL-C) measures children's self-reported knowledge and understanding of nutrition and healthy eating using an 8-question scale.",{"measure":28,"description":29,"timeFrame":20},"Health-Related Quality of Life: Parent Version (Proxy-Report)","The KINDL® proxy-report assesses the child's health-related quality of life from the parent's perspective, using the KINDL® questionnaire designed for parents to provide insights on the child's health-related quality of life.",{"measure":31,"description":32,"timeFrame":20},"Health Literacy for Children","Health Literacy Survey Questionnaire for Children (HLS-Child-Q15) assesses children's ability to seek, evaluate, and use health information, including disease prevention and health promotion.",{"measure":34,"description":35,"timeFrame":20},"Health Literacy for Adults","Health Literacy Questionnaire (HLS EU-Q16) measures general health literacy in adults, covering access, understanding, and application of health information across various health domains.",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":40,"primaryPurpose":41,"observationalModel":36,"timePerspective":36,"maskingInfo":42},"RANDOMIZED","PARALLEL","The study uses a delayed start design with two arms. In Arm 1, participants receive the intervention immediately for 12 weeks. In Arm 2, participants initially do not receive the intervention but will start the same intervention after a 12-week delay to ensure fairness.","TREATMENT",{"masking":43,"maskingDescription":36,"whoMasked":36},"NONE",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"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.",[50],"Behavioral: Digital Health Intervention",{"label":52,"type":53,"description":54,"interventionNames":36},"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.",[56],{"type":57,"name":46,"description":58,"armGroupLabels":59,"otherNames":36},"BEHAVIORAL","Access to a digital platform including weekly workout videos, live workouts, recipes, study summaries, and a consultation hour.",[46],[61],{"name":62,"affiliation":63,"role":64},"Jan Müller, Prof. Dr.","Technical University of Munich, Chair of preventive perdiatrics","PRINCIPAL_INVESTIGATOR",[66,70],{"name":62,"role":67,"phone":68,"phoneExt":36,"email":69},"CONTACT","‭0176 21149304‬","j.mueller@tum.de",{"name":71,"role":67,"phone":72,"phoneExt":36,"email":73},"Isabel Uphoff, M.Sc.","01639104022","uphoff@dhm.mhn.de",[75],{"facility":76,"status":77,"city":78,"state":36,"zip":36,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"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":82,"coordinates":83},"Point",[84,85],13.31243,51.60698,{"lat":85,"lon":84},[88],{"name":89,"role":67,"phone":90,"phoneExt":91,"email":92},"Jan Müller, PhD","+4989289","24574","j.mueller@tum.de",{"type":94,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[96,98],{"name":97,"class":6},"Technical University of Munich",{"name":99,"class":100},"Stiftung KinderHerz Deutschland gGmbH","UNKNOWN","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":111,"type":112},60,"ESTIMATED","INTERVENTIONAL",[115],"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.",[118,119],"Congenital Heart Disease","Pediatric ALL",[118,121,122,123,124,125,126,127,128,129],"Congenital Heart Defect","Child","Physical Activity","Exercise","MVPA","Digital Health","Telemedicine","Health literacy","Quality Of Life","2025-01-27",{"date":132,"type":133},"2025-01-29","ACTUAL",{"date":135,"type":133},"2024-10-01",{"date":137,"type":112},"2026-02",{"name":5,"class":6},1]