[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572564":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":61,"collaborators":63,"id":67,"slug":12,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":12,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":12,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":34,"whyStopped":12,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Center for Clinical Research and Prevention","NETWORK",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","NO_INTERVENTION","Standard antenatal care.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"HealthyPregnancy group","ACTIVE_COMPARATOR","Digital care guide as supplement to standard antenatal care.",[18],"Behavioral: HealthyPregnancy",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","HealthyPregnancy","A digital care guide comprising of:\n\n1. Information about diet, exercise and mental wellbeing in pregnancy. Presented in text, video and audio material featuring various healthcare professionals.\n2. Online exercise. Access to live online structured physical exercise twice a week and to an off line library of exercise videos.\n3. Chat function with possibility to chat safely with healthcare professionals.\n4. Push-notifications reminding the participants of upcoming antenatal appointments.\n\nIn addition an invitation to monthly café sessions focusing on e.g., mental health, parenting skills, breastfeeding and healthy lifestyle.",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Lotte Broberg, Ph.d.","CONTACT","+45 38163097","lotte.broberg.01@regionh.dk",[32,48],{"facility":33,"status":34,"city":35,"state":12,"zip":12,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Nordsjaellands Hospital","RECRUITING","Hillerød","Denmark",{"type":38,"coordinates":39},"Point",[40,41],12.30081,55.92791,{"lat":41,"lon":40},[44],{"name":45,"role":28,"phone":46,"phoneExt":12,"email":47},"Professor","004548296249","ellen.christine.leth.loekkegaard@regionh.dk",{"facility":49,"status":34,"city":50,"state":12,"zip":12,"country":36,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Slagelse Hospital","Slagelse",{"type":38,"coordinates":52},[53,54],11.35459,55.40276,{"lat":54,"lon":53},[57],{"name":58,"role":28,"phone":59,"phoneExt":12,"email":60},"Assistant professor","004538163097","lbrob@regionsjaelland.dk",{"type":62,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[64,66],{"name":33,"class":65},"OTHER",{"name":49,"class":65},"100572564",false,"NCT06734910","HealthyPregnancy - Digital Support for Pregnant Women with a BMI At 25 or Above (BMI≥25)","Effectiveness of a Digital Support Intervention (HealthyPregnancy) for Pregnant Women with a BMI At 25 or Above (BMI≥25) in Addition to Standard Care: a Stepped-wedge Cluster Randomized Controlled Trial","Inclusion Criteria:\n\n* BMI 25 or above at first prenatal visit\n* Age 18 years or older\n* Singleton pregnancy\n* Appropriate Danish or English language skills\n* Written informed consent\n\nExclusion Criteria:\n\n* Age under 18 years\n* Multiple pregnancy\n* Gestational age above 16+0 at inclusion\n* Alcohol or drug abuse\n* Being diagnosed with eating disorder, schizophrenia, psychosis, or similar\n* Diagnosis of malformations or chromosomal disorder in the fetus\n* Conditions that lead to recommendations against physical activity during pregnancy e.g., cerclage.","FEMALE","18 Years","60 Years",{"count":77,"type":78},450,"ESTIMATED","INTERVENTIONAL",[81],"NA","The study aims to examine the effectiveness of a digital care guide offering support and information on diet, physical exercise and mental well-being on pregnancy weight gain among pregnant women with a BMI at 25 or above in a stepped-wedge cluster randomised study.\n\nThe investigators hypothesise that access to a digital care guide focusing on diet, exercise and mental support, will support a reduced weight gain in pregnancy and improve the mental wellbeing of the participants.",[84,85],"Pregnancy Related","Weight Gain",[87,88,89,90,91,92],"Pregnancy","Gestational weight gain","Mental well-being","Digital interventions","Physical activity","Diet","2024-12-10",{"date":95,"type":96},"2024-12-16","ACTUAL",{"date":98,"type":96},"2024-09-09",{"date":100,"type":78},"2027-06",{"name":5,"class":6},2]