[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100427378":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":64,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":29,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":29,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":96,"overallStatus":46,"whyStopped":29,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Enhanced Usual Care","ACTIVE_COMPARATOR","The control group in this study will still receive some services above and beyond the usual standard of care offered to pregnant women on Medicaid. In addition to the case management services offered through their managed care provider, Operation Food Search will offer this group access to the \"hunger hotline,\" a service provided by Operation Food Search to help them find food assistance around St. Louis; assistance in enrolling in public nutrition assistance programs like SNAP and WIC; and guidance on food pantry access in St. Louis.",[13],"Behavioral: FreshRx Nourishing Healthy Starts",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment 1: Nutrition Services","EXPERIMENTAL","This treatment group will receive all the services offered to the control group, as well as the following services:\n\nWeekly food deliveries of fresh food meal kits with step-by-step recipes from the time of program enrollment through 60 days post-partum. Access to necessary cooking tools for their kitchen (e.g., spatulas, cutting boards , etc.), should they need them. Access to online cooking resources to help guide them on culinary skills and recipe preparation. Nutrition education and counseling provided by a registered dietitian.",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"Treatment 2: Integrated Care Services","This treatment group will receive all the services offered to Treatment Group 1, as well as the services of a Licensed Masters Social Worker who will provide trauma-informed integrative care services to participants. These services will focus on an array of potential needs that may emerge in participants' lives, such as assistance in finding stable housing, assistance navigating social services, connections with other community organizations, and other needs.",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BEHAVIORAL","FreshRx Nourishing Healthy Starts","This is a field experiment study that incorporates referrals to public programs, food supplementation and nutrition education, or integrative care services provided by a Licensed Masters Social Worker.",[9,15,20],null,[31],{"name":32,"affiliation":5,"role":33},"Stephen Roll, PhD","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":29,"email":38},"CONTACT","314-935-3710","stephen.roll@wustl.edu",{"name":40,"role":36,"phone":41,"phoneExt":29,"email":42},"Kourtney Gilbert, MSW","314-935-8142","kgilbert@wustl.edu",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Operation Food Search Inc.","RECRUITING","St Louis","Missouri","63132","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-90.19789,38.62727,{"lat":56,"lon":55},[59,63],{"name":60,"role":36,"phone":61,"phoneExt":29,"email":62},"Nancy Spargo, MSW","314-750-4077","nancy.spargo@operationfoodsearch.org",{"name":32,"role":33,"phone":29,"phoneExt":29,"email":29},{"type":65,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[67],{"name":45,"class":68},"UNKNOWN","100427378","fresh-rx-nhs-2020-100427378",false,"NCT04845230","Fresh RX: NHS 2020","Fresh RX: Nourishing Healthy Starts Clinical Study","Inclusion Criteria:\n\n* Female\n* Pregnant\n* Less than 24 weeks gestation\n* Screening positive to a USDA two-item food insecurity screener (described below)\n* Receiving care through a Missouri Medicaid managed care organization\n* English speaking\n* Age 14-55\n* Missouri resident residing in the following zip codes: 63031, 63033, 63042, 63074, 63114, 63121, 63130, 63132, 63133, 63135, 63136, 63137, 63138, 63140\n\nExclusion Criteria:\n\n* Male\n* Non-pregnant\n* Pregnant, but more than 24 weeks gestation\n* Does not screen positive to a USDA two-item food insecurity screener (described below)\n* Does not receive care through the Home State Health managed care organization\n* Non-English speaking\n* Aged less than 14 or more than 55\n* Does not reside in the following zip codes: 63031, 63033, 63042, 63074, 63114, 63121, 63130, 63132, 63133, 63135, 63136, 63137, 63138, 63140",true,"FEMALE","14 Years","55 Years",{"count":81,"type":82},750,"ESTIMATED","INTERVENTIONAL",[85],"NA","This study is an evaluation of the Fresh Rx: Nourishing Healthy Starts program administered by Operation Food Search, a St. Louis-based nonprofit organization. The program provides food and nutrition supports to food insecure pregnant women in conjunction with integrative care services in order to improve health and birth outcomes for both the mother and the child. The purpose of this study is to test the efficacy of this approach through a field experiment, and to assess the extent to which these services can provide cost savings to the healthcare system.",[88,89,90,91,92,93,94,95],"Premature Birth","Birth Weight","Post Partum Depression","Health Care Utilization","Nutrition Deficiency Due to Insufficient Food","Housing Problems","Fetal Complications","Food Deprivation",[97,98,99,100,101,102,103,104,105],"food insecurity","pregnancy","maternal health","neonatal health","birth outcomes","poverty","health care utilization","field experiment","integrative care","2022-11-27",{"date":108,"type":109},"2022-11-29","ACTUAL",{"date":111,"type":109},"2021-08-09",{"date":113,"type":82},"2026-09-15",{"name":5,"class":6},1]