[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"GrowBaby Life Project\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":4},"100635983","the-root-study-scaling-the-standard-of-care-plus-obstetric-nutrition-model-to-optimize-maternal-and-infant-health-100635983",false,"NCT07559773","The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Model to Optimize Maternal and Infant Health","The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Integrated Model to Optimize Maternal and Infant Health: a Prospective Interventional Study: Resilient Outcomes Through OB-Nutrition Team Care (ROOT)","ROOT","Inclusion Criteria:\n\n* Pregnant women receiving care at NH Triad OB\u002FGYN\n* ≤20 weeks gestational age at enrollment\n* Age ≥ 18 years (\\\u003C18 years requires parental consent)\n* Ability to provide informed consent\n* Access to smart phone\u002Finternet for digital platform use\n\nExclusion Criteria:\n\n* \\> 20 weeks gestational age\n* High-risk pregnancies requiring specialized care beyond study scope\n* Inability to participate in digital health platform\n* Cognitive impairment preventing informed consent","FEMALE","18 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"NA","The 'Standard of Care Plus' ('PLUS') model in the ROOT Study consists of analyzing select micronutrient and gene variants of pregnant females to construct trimester-specific and personalized nutrition and lifestyle recommendations in collaboration with in-person standard obstetric care (SOC).\n\nIn 2014, the investigators demonstrated statistically significant reductions in adverse maternal and infant outcomes using the 'PLUS' model compared to SOC alone. Further study in a 50% Medicaid Oregon 'PLUS' cohort (N=387) demonstrated association with highly significant risk reductions in all primary outcomes (p-value \\\u003C0.001): preterm birth: relative risk (RR) = 0.238 (4.2x less likely), hypertensive disorders of pregnancy: RR = 0.229 (4.4x less likely), gestational diabetes: RR = 0.071 (14x less likely), small for gestational age: RR = 0.252 (4x less likely), and large for gestational age: RR = 0.357 (2.8x less likely). A 100% Medicaid and ethnically diverse Nevada 'PLUS' cohort showed similar trends in all outcomes that were not statistically significant because of small sample size.\n\nStructured as a prospective interventional study, the study evaluates whether the 'PLUS' model can achieve similar outcome improvements within the Novant Health (NH) system in North Carolina. The study will assess both clinical outcomes and digital nutrition platform performance within the existing healthcare infrastructure.\n\nThe primary hypothesis of the ROOT study is that collaborative implementation of the 'PLUS' nutritional care model at NH Triad Obstetrics\u002FGynecology (OB\u002FGYN) Clinic will be associated with reduced maternal and infant adverse outcome rates when compared to historical regional and NH system outcomes in those who received SOC alone.\n\nThe secondary hypothesis of the ROOT Study is that the 'PLUS' model applied during pregnancy will be associated with reduced pediatric adverse outcomes. The 'PLUS' offspring that remain in the NH system will be observed longitudinally over 5 years with chart review at birth through 2 weeks of age, and at 1, 3, and 5 years of life. The outcomes assessed include neonatal intensive care unit (NICU) admission in the first two weeks of life, atopic dermatitis, eczema, asthma, allergies, otitis media, obesity, and autism. The 'PLUS' adverse outcome rates will be compared to adverse outcome rates in children born regionally and nationally under SOC alone.\n\nParticipant compliance with the 'PLUS' model, and participant and nutritionist access to the digital health platform will be studied during each trimester of use, as well as in the postpartum time period. The exploratory hypothesis is that the digital platform will not affect access, compliance, and rates of maternal and neonatal adverse outcomes.",[27,28,29,30,31,32,33,34,35,36],"Preterm Birth","Preeclampsia","Gestational Diabetes Mellitus (GDM)","Small for Gestational Age (SGA)","Large for Gestational Age (LGA)","Asthma Childhood","Atopic Dermatitis","Autism","Otitis Media Recurrent","Obesity",[38,39,40,41,42,43,44,45,46,47],"adverse pregnancy outcomes","prevention","personalized nutrition","nutrigenomics","adverse neonatal outcomes","childhood asthma","childhood allergy","autism","childhood obesity","recurrent otitis media","NOT_YET_RECRUITING","2026-04-27",{"date":51,"type":52},"2026-04-30","ACTUAL",{"date":54,"type":21},"2026-08",{"date":56,"type":21},"2033-12",{"name":58,"class":59},"GrowBaby Life Project","OTHER",""]