[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555283":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":49,"centralContacts":55,"locations":61,"responsibleParty":78,"collaborators":81,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":28,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":112,"overallStatus":63,"whyStopped":28,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Digital Health Intervention (DHI)","EXPERIMENTAL","This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower.",[13],"Behavioral: Digital Health intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Community health worker (CHW)","Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called \"From Day One (FDO)\", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through 12 weeks postpartum. The intervention has been modified by the POPPY Study Team and Community Advisory Board",[18],"Behavioral: Community Health Worker",{"label":20,"type":10,"description":21,"interventionNames":22},"DHI Plus CHW","This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.",[23],"Behavioral: Digital Health Intervention plus Community Health Worker",{"label":25,"type":26,"description":27,"interventionNames":28},"Usual Care","NO_INTERVENTION","This group will receive routine prenatal care services.",null,[30,37,43],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"BEHAVIORAL","Digital Health intervention","Health care information delivered via a link in a text message that is then opened in a secure browser.",[9],[36],"DHI",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Community Health Worker","Health care information delivered via CHW.",[15],[42],"CHW",{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Digital Health Intervention plus Community Health Worker","Health care information delivered via DHI plus CHW",[20],[48],"DHI plus CHW",[50,53],{"name":51,"affiliation":5,"role":52},"Rachel Sinkey, MD","PRINCIPAL_INVESTIGATOR",{"name":54,"affiliation":5,"role":52},"Wally Carlo, MD",[56],{"name":57,"role":58,"phone":59,"phoneExt":28,"email":60},"Rosylen \"Roz\" Quinney","CONTACT","205.934.1309","rquinney@uabmc.edu",[62],{"facility":5,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-86.80249,33.52066,{"lat":73,"lon":72},[76],{"name":77,"role":58,"phone":59,"phoneExt":28,"email":60},"Rosylen Quinney",{"type":52,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Rachel Sinkey","Associate Professor",[82,84,87],{"name":83,"class":6},"American Heart Association",{"name":85,"class":86},"ConnectionHealth","UNKNOWN",{"name":88,"class":86},"Memora Health","100555283","providing-an-optimized-and-empowered-pregnancy-for-you-poppy-aim-3-randomized-controlled-trial-100555283",false,"NCT06510075","Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial","Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Aim 3: Randomized Controlled Trial","P3OPPY","Inclusion Criteria:\n\n* Self Identifies as Non-Hispanic Black\n* Between 16-49 years old\n* Pregnant individuals between 8⁰ - 22⁶ weeks gestational age\n* Live singleton or dichorionic twin gestation\n* Dating sonogram at \\\u003C23 weeks gestation,\n* Area Deprivation Index (ADI) National 4th or 5th Quintile\n* Planning to deliver at UAB Hospital\n* Speaks and writes in English\n* No indication for delivery at the time of enrollment\n\nExclusion Criteria:\n\n* Declines randomization\n* Speaks or writes in languages other than English\n* Currently incarcerated\n* Fetal demise diagnosed prior to enrollment\n* Known major structural chromosomal abnormalities prior to enrollment\n* Participated in POPPY Pilot","FEMALE","16 Years","49 Years",{"count":101,"type":102},400,"ESTIMATED","INTERVENTIONAL",[105],"NA","The PᵌOPPY study is designed to support the American Heart Association's mission to improve maternal\u002Finfant health outcomes and address inequities in maternal\u002Finfant health care. The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in Maternal and Infant Health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information, care, and experiences during pregnancy, postnatal and postpartum\u002Fpreconception periods, particularly for Black and under-served populations. Collectively, the investigators will collaborate with pregnant and postpartum individuals and their families, hospitals, and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes. In this trial, 400 non-Hispanic Black participants will be randomized to see if 2 promising interventions (digital health interventions and community health workers) reduce adverse pregnancy outcomes.",[108,109,110,111],"Pregnancy Complications","Maternal Distress","Adverse Birth Outcomes","Infant Conditions",[113,114],"Pregnancy outcomes","Health inequities","2025-08-13",{"date":117,"type":118},"2025-08-17","ACTUAL",{"date":120,"type":118},"2024-08-01",{"date":122,"type":102},"2027-01-31",{"name":5,"class":6},1]