[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diet-during-pregnancy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diet-during-pregnancy":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":45,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100634052","early-pregnancy-lifestyle-and-glucose-patterns-a-substudy-of-tofffy-100634052",false,"NCT07534670","Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY","Early-Pregnancy Chronobehavioural Profiles and Continuous Glucose Dynamics: A Nested Randomised Pilot Study of TOFFFY","Inclusion Criteria:\n\n* Enrolled in the Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) (NCT06293235)\n* Females who are currently pregnant and with viable intrauterine pregnancy at ≤13 weeks gestation at enrolment\n\nExclusion Criteria:\n\n* Females with pre-existing diabetes mellitus (Type 1 or Type 2) and\u002For chronic medical conditions affecting glucose metabolism\n* Females who are taking medications known to significantly affect glucose metabolism\n* Females with multiple pregnancy (e.g., twins or higher-order gestation)\n* Females who are unable to comply with study procedures, including: Inability to use smartphone-based applications and inability to wear wrist actigraphy device",true,"FEMALE","21 Years","39 Years",{"count":21,"type":22},140,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to examine how daily behavioral patterns in early pregnancy, including sleep, physical activity, and meal timing, influence continuous glucose dynamics and subsequent risk of gestational diabetes mellitus (GDM) in pregnant women without pre-existing diabetes.\n\nThe main questions it aims to answer are:\n\n1. Do early-pregnancy chronobehavioral patterns (e.g., irregular sleep, night eating, and unstable rest-activity rhythms) relate to continuous glucose patterns measured using continuous glucose monitoring (CGM)?\n2. Can early behavioral and CGM-derived measures predict glucose regulation and metabolic outcomes later in pregnancy (24-28 weeks)?\n3. Does real-time self-monitoring using wearable devices and food logging improve glycemic outcomes compared to usual care?\n\nThis study is a prospective, nested randomized pilot trial embedded within the ongoing Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) cohort (NCT06293235) at KK Women's and Children's Hospital, Singapore. A total of 140 pregnant women without pre-existing diabetes, recruited at ≤13 weeks gestation, will be randomized in a 1:1 ratio to either a pilot arm (wearable-based self-monitoring) or a control arm (usual care).\n\nParticipants in the pilot arm (n=70) will undergo intensive behavioral and metabolic monitoring over a 14-day period in early pregnancy, including continuous glucose monitoring using a CGM device, wrist actigraphy to assess sleep-wake and rest-activity patterns, and an AI-supported mobile application to record meal timing and dietary intake. Participants will have real-time access to their glucose data and behavioral feedback, enabling self-monitoring and potential behavioral adjustments.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Continuous Glucose Monitoring","Diabetes, Gestational","Diet During Pregnancy","Meal Time","Actigraphy","Pregnancy","Glucose Intolerance During Pregnancy","Gestational Diabetes Mellitus in Pregnancy","Circadian Rhythm","Sleep","Chronobiology","Wearable Electronic Devices","Mobile Applications","Blood Glucose Profile","Metabolic Diseases","Randomized Controlled Trial","Pilot Study",[46,47,48,49,50,51],"Risk factor","Lifestyle","Early pregnancy","Chrono-disruptive behaviours","Maternal health","Lifestyle intervention","NOT_YET_RECRUITING","2026-04-22",{"date":55,"type":56},"2026-04-27","ACTUAL",{"date":58,"type":22},"2026-05-01",{"date":60,"type":22},"2027-06-30",{"name":62,"class":63},"KK Women's and Children's Hospital","OTHER_GOV",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":73,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":64},"100528021","vegetalization-of-the-maternal-diet-during-pregnancy-association-with-pregnancy-outcomes-and-newborn-health-100528021","NCT06155344","Vegetalization of the Maternal Diet During Pregnancy: Association With Pregnancy Outcomes and Newborn Health.","VEGALIM : Vegetalization of the Maternal Diet During Pregnancy: Association With Pregnancy Outcomes and Newborn Health.","VEGALIM","Inclusion Criteria :\n\n* Pregnant women consulting the CEMAFOER at the Nantes University Hospital for pregnancy monitoring\n* Gestational age between 11 and 13 AW +6 days\n* Understanding French\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Patient who objected to being included in the study\n* Patient with cognitive problems that prevent her from answering questionnaires","18 Years",{"count":75,"type":22},670,"OBSERVATIONAL","Reducing consumption of foods of animal origin in favor of more plant-based diets is a major environmental, public health and economic challenge. Data on the health effects of highly vegetalized diets are available only in adults. Few studies report the effect of the level of vegetalization of the maternal diet during pregnancy on the mother's health, and the development and health of the child. The VEGALIM project aims to describe the level of vegetalization of pregnant women's diets and the nutritional quality of their diets early in pregnancy (first trimester) and late pregnancy, and to explore the potential effects on their plasma lipid profile that may impact on their health during pregnancy and the health of the newborn.",[30],[33,80,81,82],"Newborn","Vegetalization","Food","RECRUITING","2026-02-05",{"date":86,"type":56},"2026-02-09",{"date":88,"type":56},"2024-03-18",{"date":90,"type":22},"2027-12-18",{"name":92,"class":93},"Nantes University Hospital","OTHER"]