[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648140":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":52,"collaborators":26,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":26,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":93,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Thai Binh University of Medicine and Pharmacy","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Habits","EXPERIMENTAL","A co-created intervention delivered during pregnancy and up to two years after birth that includes counselling, peer support, digital health elements, educational materials, and follow-up support on nutrition, infant feeding practices, physical activity, and GDM management provided according to routine clinical practice in the Hung Yen province, Vietnam",[13],"Behavioral: Hybrid intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care + Web Access","ACTIVE_COMPARATOR","Access to a website with GDM management + standard care",[19],"Behavioral: Standard Care with Passive Web Access",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Hybrid intervention","The VALID III \"Healthy Habits\" intervention is a culturally tailored, gender-sensitive, intergenerational complex intervention for women with gestational diabetes mellitus (GDM), delivered from diagnosis to 24 months postpartum. It differs from standard care through its extended duration and integrated family- and digital-based approach.\n\nIt includes five components: (1) nutrition and infant feeding support (diet, breastfeeding, complementary feeding, household practices); (2) physical activity guidance for pregnancy\u002Fpostpartum and family active play; (3) intergenerational family engagement involving partners and grandparents; (4) self-care and GDM management including diet advice, blood glucose monitoring, and free clinic testing; and (5) digital support via messaging and educational content.\n\nCompared with usual care, the intervention integrates co-created materials, family involvement, and continuous digital engagement to support sustained behavioural change",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Care with Passive Web Access","Participants in this control group receive standard care for GDM according to routine clinical practice in Vietnam (antenatal care, dietary advice, glucose monitoring). In addition, they are provided with a website link (https:\u002F\u002Fwww.babaukhoemanh.com\u002Fen) for passive access to basic GDM management guidance. They do not receive any proactive messaging, peer support, or family engagement",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Thanh Duc Nguyen, Assoc. Prof","CONTACT","+84 91 235 7575","bsthanh@hotmail.com",[38],{"facility":5,"status":26,"city":39,"state":40,"zip":26,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Thái Bình","Hưng Yên Province","Vietnam","VN",{"type":44,"coordinates":45},"Point",[46,47],106.34002,20.45,{"lat":47,"lon":46},[50],{"name":51,"role":34,"phone":35,"phoneExt":26,"email":36},"Thanh Duc Nguyen, Phd",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Thanh Duc Nguyen","Head of International Relations Department","100648140","healthy-habits-during-and-after-gestational-diabetes-100648140",false,"NCT07717515","Healthy Habits During and After Gestational Diabetes","Healthy Habits During and After Gestational Diabetes: A Cluster Randomised Family Intervention Controlled Trial in Northern Vietnam (VALID III)","VALID III","Inclusion Criteria:\n\n* Confirmed GDM diagnosis in the current pregnancy according to WHO criteria and enrolled no longer than seven days after diagnosis.\n* Gestational age at enrolment ≤ 28+0 weeks of pregnancy.\n* Maternal age ≥18 years at consent.\n* Pregnancy with singleton gestation\n* Residence within the study catchment area.\n* Language proficiency sufficient to complete consent and study procedures in Vietnamese.\n* Capacity to provide informed consent and willingness to participate in all trial procedures, including randomisation\n\nExclusion Criteria:\n\n* Pregestational diabetes (type 1 or type 2) diagnosed prior to this pregnancy.\n* Severe chronic medical conditions and chronic severe mental health conditions likely to interfere with participation, safety, or outcome assessment (e.g., advanced cardiac, renal, hepatic disease; active malignancy; severe uncontrolled endocrine disease other than GDM, schizophrenia, active psychosis).\n* Inability to provide informed consent .\n* Pregnant women with multiple gestations.\n* Pregnant women where it is biologically impossible for the woman to breastfeed, e.g., the woman has undergone bilateral mastectomy.\n* Any other condition that, in the judgment of the investigators, makes participation inappropriate or infeasible, e.g., surrogate mother.","FEMALE","18 Years",{"count":67,"type":68},2546,"ESTIMATED","INTERVENTIONAL",[71],"NA","Gestational diabetes mellitus (GDM) is associated with an increased risk of childhood obesity and other adverse health outcomes. Early-life nutrition, particularly exclusive breastfeeding, plays an important role in reducing this risk. In Vietnam, infant feeding and childcare practices are strongly influenced by family members, including husbands, grandparents, and parents-in-law.\n\nThe Healthy Habits During and After Gestational Diabetes (VALID III) trial aims to evaluate the effect of a co-created family-based health intervention on improving infant feeding practices and childhood body composition among children born to women with GDM. The intervention includes counseling, peer support, digital health components, educational materials, and follow-up support for nutrition, infant feeding practices, physical activity, and GDM management from pregnancy through 24 months after birth. Participants in the control group will receive standard care together with access to a GDM management website.\n\nThe primary objective is to evaluate the effect of the intervention on the duration of exclusive breastfeeding during the first 180 days after birth. Secondary objectives include evaluating exclusive breastfeeding at 6 months, child fat mass index at 24 months, and broader maternal and child health and wellbeing outcomes.",[74],"GDM",[76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,41,92],"Gestational diabetes mellitus","exclusive breastfeeding","infant feeding","pregnancy hyperglycaemia","early-life nutrition","child adiposity","fat mass index","childhood obesity","lifestyle intervention","behavioural intervention","family-based intervention","caregiver involvement","maternal nutrition","physical activity","postpartum health","complementary feeding","low- and middle-income countries","NOT_YET_RECRUITING","2026-07-20",{"date":96,"type":97},"2026-07-22","ACTUAL",{"date":99,"type":68},"2026-11-15",{"date":101,"type":68},"2030-08-30",{"name":5,"class":6},1]