[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631357":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":65,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":18,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":18,"enrollmentInfo":80,"targetDuration":18,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":18,"overallStatus":89,"whyStopped":18,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Peking University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Digital Health Intervention","EXPERIMENTAL","Participants in this arm will receive a digital health intervention in addition to routine antenatal care. The intervention includes online health education, individualized lifestyle guidance, self-management tools, health information delivery, and interactive consultation through a digital platform. The intervention focuses on gestational weight management, diet, physical activity, sleep, and prevention of gestational diabetes mellitus.",[13],"Behavioral: Digital Health Lifestyle Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","NO_INTERVENTION","Participants in this arm will receive routine antenatal care and standard pregnancy health education provided by the hospital, without additional digital health intervention.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Digital Health Lifestyle Intervention","Participants receive a digital health lifestyle intervention in addition to routine antenatal care. The intervention is delivered through a digital platform and includes online health education, individualized lifestyle guidance, self-management tools, health information delivery, and interactive consultation. The intervention focuses on gestational weight management, diet, physical activity, sleep, and early prevention of gestational diabetes mellitus among pregnant women identified as high risk.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Jue Liu, PhD","CONTACT","+86 13426455743","jueliu@bjmu.edu.cn",[32,50],{"facility":33,"status":18,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Beijing Tongzhou Maternal and Child Health Hospital","Beijing","Beijing Municipality","10010","China","CN",{"type":40,"coordinates":41},"Point",[42,43],116.39723,39.9075,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":48,"phoneExt":18,"email":49},"Tao Su, PhD","+86 18605021872","18605021872@163.com",{"facility":51,"status":18,"city":52,"state":53,"zip":54,"country":37,"countryCode":38,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Weifang Maternal and Child Health Hospital","Weifang","Shandong","261042",{"type":40,"coordinates":56},[57,58],119.10194,36.71,{"lat":58,"lon":57},[61],{"name":62,"role":28,"phone":63,"phoneExt":18,"email":64},"Xiansheng Ding","+86 0536-5919002","2411210109@stu.pku.edu.cn",{"type":66,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[68],{"name":69,"class":70},"National Natural Science Foundation of China","OTHER_GOV","100631357","digital-health-intervention-for-early-identification-and-prevention-of-gestational-diabetes-mellitus-100631357",false,"NCT07499622","Digital Health Intervention for Early Identification and Prevention of Gestational Diabetes Mellitus","A Multicenter Randomized Controlled Trial of a Digital Health Intervention for Risk Identification, Intelligent Early Warning, and Prevention of Gestational Diabetes Mellitus Based on Multi-Source Data Integration","Inclusion Criteria:\n\n* Pregnant women in early pregnancy (within 13 weeks and 6 days of gestation)\n* Planned delivery at a participating study hospital\n* Age 18 years or older\n* Singleton pregnancy\n* Identified as high risk for gestational diabetes mellitus by the study risk assessment model\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* • Pre-pregnancy diabetes mellitus or overt diabetes diagnosed at the first antenatal visit (fasting blood glucose greater than or equal to 7.0 mmol\u002FL)\n\n  * Pre-existing hypertension, autoimmune disease, major infection, or severe liver or kidney disease\n  * Use of medications that affect glucose metabolism, such as corticosteroids or metformin\n  * Severe psychiatric disorders\n  * Inability or unwillingness to comply with study procedures","FEMALE","18 Years",{"count":81,"type":82},1200,"ESTIMATED","INTERVENTIONAL",[85],"NA","This study aims to develop and evaluate an early risk identification and digital health intervention strategy for gestational diabetes mellitus (GDM) among pregnant women in China. Gestational diabetes mellitus is a common pregnancy complication associated with adverse maternal and neonatal outcomes, including excessive gestational weight gain, macrosomia, cesarean delivery, and increased long-term risk of metabolic disorders in both mothers and offspring.\n\nThe study includes two components. First, retrospective multi-source clinical data from maternal health records will be used to develop and validate a risk prediction model for early identification of pregnant women at high risk of GDM. Second, pregnant women identified as high risk in early pregnancy will be enrolled in a multicenter randomized controlled trial and assigned to either a digital health intervention group or a usual care group. The intervention includes online health education, individualized lifestyle guidance, behavioral self-management tools, and interactive consultation through a digital platform. The primary outcome is the incidence of GDM diagnosed during pregnancy. Secondary outcomes include gestational weight gain, cesarean delivery, macrosomia, and other maternal and neonatal outcomes.\n\nThis study is expected to provide evidence for improving early risk assessment, intelligent warning, and prevention strategies for GDM in the context of maternal health management in China.",[88],"Gestational Diabetes Mellitus (GDM)","NOT_YET_RECRUITING","2026-03-24",{"date":92,"type":93},"2026-03-30","ACTUAL",{"date":95,"type":82},"2026-06",{"date":97,"type":82},"2028-12",{"name":5,"class":6},2]