[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605705":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":52,"collaborators":11,"id":55,"slug":11,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":11,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":11,"overallStatus":72,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Food is Medicine (FIM) Intervention plus Standard of Care","EXPERIMENTAL",null,[13,14],"Behavioral: Food is Medicine (FIM) Intervention","Behavioral: Standard of Care",{"label":16,"type":17,"description":11,"interventionNames":18},"Standard of Care","ACTIVE_COMPARATOR",[14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"BEHAVIORAL","Food is Medicine (FIM) Intervention","Intensive intervention phase - this phase starts at enrollment (\\\u003C=14 weeks) through 28 weeks of gestation (or at the time of GDM diagnostic test) and women i) receive a bi-weekly home delivery of a \"mixed box\" consisting of fresh produce, lean protein, and whole grains combined with culinary medicine-based nutrition education available in English and Spanish.\n\nMaintenance phase - this phase starts at 29 weeks through 12 weeks postpartum, and women will receive biweekly deliveries of about 10-15 pounds of fresh produce (8-10 different kinds of produce) plus standard nutrition education. The box will be curated for prenatal nutrients needs and following American Diabetes Association guidelines.",[9],{"type":21,"name":16,"description":26,"armGroupLabels":27,"otherNames":11},"Standard medical care provided at Harris Health for high-risk pregnant women, plus a voucher equal to the value of the produce and meals provided in the Food is Medicine (FIM) Intervention.",[9,16],[29],{"name":30,"affiliation":5,"role":31},"Shreela Sharma, PhD","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":11,"email":36},"CONTACT","(713) 500-9344","Shreela.V.Sharma@uth.tmc.edu",[38],{"facility":39,"status":11,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The University of Texas Health Science Center at Houston","Houston","Texas","77006","United States",{"type":45,"coordinates":46},"Point",[47,48],-95.36327,29.76328,{"lat":48,"lon":47},[51],{"name":30,"role":34,"phone":35,"phoneExt":11,"email":36},{"type":31,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Shreela V Sharma","Professor","100605705",false,"NCT07165990","Produce Rx in High Risk Pregnant Mothers at Harris Health","Inclusion Criteria:\n\n* pregnant women receiving care at Harris Health clinics\n* Medicaid eligible or receiving Medicaid\n* \\\u003C=14 weeks gestation at the time of the first prenatal visit and study enrollment\n* meet the ACOG criteria for early screening for GDM (have a BMI of 30 or greater and at least one additional ACOG-designated risk factor for GDM from the following: Age \\> 35 years; Black, Hispanic, Native American, Asian American or Pacific Islander ethnicity; history of GDM in prior pregnancy; A1c level \\> 5.7 \\& \\\u003C 6.4; history of hypertension, pregnancy hypertension, heart disease, HIV, high triglycerides, polycystic ovarian syndrome; Immediate family member (parent or sibling) has had diabetes)\n* fall within the study delivery radius\n\nExclusion Criteria:\n\n* report existing or pregestational T2DM\n* have hemoglobin A1c\\>=7\n* are prescribed insulin therapy or metformin upon first screening","FEMALE","18 Years","44 Years",{"count":64,"type":65},400,"ESTIMATED","INTERVENTIONAL",[68],"NA","The purpose of this study is to assess the effectiveness of a \"Food is Medicine\" (FIM) intervention on incidence of gestational diabetes mellitus (GDM) among pregnant women at risk for GDM within the Harris Health system.",[71],"Gestational Diabetes Mellitus","NOT_YET_RECRUITING","2025-09-02",{"date":75,"type":76},"2025-09-10","ACTUAL",{"date":78,"type":65},"2025-09-08",{"date":80,"type":65},"2026-10-01",{"name":5,"class":6},1]