[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473193":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":53,"studyPopulation":50,"armGroups":54,"interventions":65,"overallOfficials":71,"centralContacts":76,"locations":86,"responsibleParty":138,"collaborators":141,"id":150,"slug":50,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":157,"sex":158,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":50,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":89,"whyStopped":50,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"fullName":5,"class":6},"Endeavor Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"Breastfeeding duration","Total length of time in weeks that breastmilk feeds were provided to the infant, collected via participant self-report.","6 weeks postpartum",{"measure":10,"description":11,"timeFrame":14},"6 months postpartum",[16,20,23],{"measure":17,"description":18,"timeFrame":19},"Breastfeeding intensity-inpatient","Proportion of infant feedings during the delivery admission that are breastmilk only. Number of breastmilk feeds will be divided by the total number of infant feedings.","During Delivery Admission",{"measure":21,"description":22,"timeFrame":12},"Breastfeeding intensity-post discharge","Proportion of infant feedings that are breastmilk only. Intensity will be calculated as # breastmilk feeds\u002Fday divided by total number of infant feedings\u002Fday as recorded in the infant feeding logs completed by study participants.",{"measure":21,"description":22,"timeFrame":14},[25,29,30,31,34,37,40,43,44],{"measure":26,"description":27,"timeFrame":28},"Breastfeeding knowledge","Breastfeeding Knowledge Questionnaire, and questions regarding behavioral norms around breastfeeding","Baseline 12-20 weeks",{"measure":26,"description":27,"timeFrame":12},{"measure":26,"description":27,"timeFrame":14},{"measure":32,"description":33,"timeFrame":28},"Infant feeding attitude- Iowa Infant Feeding Attitude Scale (IIFAS)","The Iowa Infant Feeding Attitudes Scale; 26 items with a 5 point likert scale, half of which measure favorability towards breastfeeding and the remaining half measuring favorability towards formula feeding, higher scores reflect positive attitudes towards breastfeeding and lower scores reflect positive attitudes towards formula.",{"measure":35,"description":36,"timeFrame":12},"Ci-BPC related costs","The time spent in BPC inpatient encounters, outpatient\u002Ftelehealth appointments and support group sessions, travel time for BPC appointments, transportation for BPC appointments, and cellular data for telehealth BPC appointments.",{"measure":38,"description":39,"timeFrame":12},"Out of pocket cost","Supplies purchased for infant feeding, including breastfeeding supplies (e.g., pump and parts, storage, contained, bras, breast pads, billows), bottles, formula, and addition food cost (including supplements)",{"measure":41,"description":42,"timeFrame":12},"Feeding related opportunity costs","Time spent feeding infants (preparation, feeding, and clean up) for type of feeding (breast milk at breast, breast milk by bottle, formula)",{"measure":32,"description":33,"timeFrame":12},{"measure":32,"description":33,"timeFrame":14},{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":50,"timePerspective":50,"maskingInfo":51},"RANDOMIZED","PARALLEL","Patients will be randomized 1:1 to either standard lactation care or to standard lactation care plus clinically-integrated breastfeeding peer counseling","TREATMENT",null,{"masking":52,"maskingDescription":50,"whoMasked":50},"NONE","FEEDS is a randomized control trial comparing standard lactation care to standard lactation care plus a ci-BPC. This trial will take place at three hospitals in the Chicago land area, Swedish Hospital, Highland Park Hospital, and University of Chicago Medicine Hospital. The aims of the study are: (1) To determine whether ci-BPC reduces disparities in breastfeeding outcomes for Black and Hispanic\u002FLatine participants, (2)To determine whether ci-BPC improves breastfeeding knowledge, attitude, access to support, and empowerment, (3) To understand implementation outcomes, facilitators, and barriers, and (4) To identify associated patient centered costs.",[55,59],{"label":56,"type":57,"description":58,"interventionNames":50},"Standard of care","NO_INTERVENTION","Standard lactation care is provided by postpartum RNs on the inpatient unit and RNs who are board certified in lactation (IBCLCs).Postpartum RNs provide support to all patients post delivery with direct breastfeeding, breast pump use, and addressing routine breastfeeding concerns. IBCLCs provide direct lactation care for more complicated lactation problems and is delivered in a dosed manner based on the nature of the lactation problem, with low-risk patients often having no encounters.",{"label":60,"type":61,"description":62,"interventionNames":63},"ci-BPC with Standard of Care","ACTIVE_COMPARATOR","In addtion to normal standard of care (as described above), patients will also receive clinically-integrated breastfeeding peer counseling (ci-BPC) from a Peer Counselor at four timepoints throughout the perinatal period. The encounters will take place either in person or virtually and include: an intake encounter between 2- and 30 weeks gestation, a dedicated prenatal infant feeding education encounter, at least one inpatient encounter post-delivery during the delivery admission, and at least one postpartum encounter. Patients will also have access to a \"warmline\" that will include phone follow up by the next business day.",[64],"Behavioral: Ci-BPC with Standard of Care (SOC)",[66],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":50},"BEHAVIORAL","Ci-BPC with Standard of Care (SOC)","Clinically-integrated breastfeeding peer counseling (ci-BPC) is a practice that, supports the patient and the clinical care team by delivering culturally-appropriate breastfeeding help to motivate breastfeeding initiation, intensity, and duration, inspiring confidence for patients to set breastfeeding goals and meet them. ci-BPC is delivered by community health workers who have breastfed an infant, and have received basic training in breastfeeding support through a qualified BPC training organization. For this project, the Peer Counselor will make initial contact to patients randomized into the treatment arm via phone to schedule the Intake Encounter between 20 and 30 weeks gestation. Subsequently, each patient will receive a minimum of 3 additional encounters which can occur virtually or in-person. Patients randomized to the ci-BPC arm are additionally offered access to a \"warmline\" where messages will be returned by the next business day.",[60],[72],{"name":73,"affiliation":74,"role":75},"Ann Borders, MD, MS","Endeavor Health (NorthShore University HealthSystem)","PRINCIPAL_INVESTIGATOR",[77,82],{"name":78,"role":79,"phone":80,"phoneExt":50,"email":81},"Lauren Keenan-Devlin, MPH, PhD","CONTACT","8475701971","lkeenan-devlin@northshore.org",{"name":83,"role":79,"phone":84,"phoneExt":50,"email":85},"Ashley B Walther, MS","8475702652","awalther@northshore.org",[87,104,113,126],{"facility":88,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Swedish Hospital","RECRUITING","Chicago","Illinois","60625","United States","US",{"type":96,"coordinates":97},"Point",[98,99],-87.65005,41.85003,{"lat":99,"lon":98},[102],{"name":103,"role":79,"phone":80,"phoneExt":50,"email":81},"Lauren Keenan-Devlin, PhD, MPH",{"facility":105,"status":89,"city":90,"state":91,"zip":106,"country":93,"countryCode":94,"cosmosGeoPoint":107,"geoPoint":109,"contacts":110},"UChicago Medicine Hospital (University of Chicago)","60637",{"type":96,"coordinates":108},[98,99],{"lat":99,"lon":98},[111],{"name":103,"role":79,"phone":80,"phoneExt":50,"email":112},"groberts@northshore.org",{"facility":74,"status":114,"city":115,"state":91,"zip":116,"country":93,"countryCode":94,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"NOT_YET_RECRUITING","Evanston","60201",{"type":96,"coordinates":118},[119,120],-87.69006,42.04114,{"lat":120,"lon":119},[123],{"name":124,"role":79,"phone":50,"phoneExt":50,"email":125},"Robert Stanton, JD","RStanton@northshore.org",{"facility":127,"status":89,"city":128,"state":91,"zip":129,"country":93,"countryCode":94,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Highland Park Hospital","Highland Park","60035",{"type":96,"coordinates":131},[132,133],-87.80034,42.18169,{"lat":133,"lon":132},[136],{"name":137,"role":79,"phone":80,"phoneExt":50,"email":112},"Lauren Keenan-Devline, PhD, MPH",{"type":75,"investigatorFullName":139,"investigatorTitle":140,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"Ann Borders","Principal Investigator",[142,144,146,148],{"name":143,"class":6},"Patient-Centered Outcomes Research Institute",{"name":145,"class":6},"Northwestern University",{"name":147,"class":6},"University of Chicago",{"name":149,"class":6},"Rush University","100473193",false,"NCT05441709","Furthering Equity Through Infant Feeding EDucation and Support","Clinically Integrated Breastfeeding Peer Counseling to Promote Breastfeeding Equity","FEEDS","Inclusion Criteria:\n\n* 12 and 24 weeks gestation\n* English or Spanish speaking\n* Planning to parent their infant\n* Planning to deliver at SH, HPH or UCM\n* No prior exposure to ci-BPC\n\nExclusion Criteria:\n\n* considering pregnancy termination or adoption\n* Prior exposure to ci-BPC",true,"ALL","18 Years","45 Years",{"count":162,"type":163},990,"ESTIMATED","INTERVENTIONAL",[166],"NA","The purpose of this study is to identify whether adding clinically integrated breastfeeding peer counseling (ci-BPC) to standard lactation care is associated with a reduction in disparities in breastfeeding intensity and duration for Black and Hispanic\u002FLatine families.",[169],"Breastfeeding",[169,171,172,173],"Peer Counseling","Lay health worker","Infant Feeding","2025-12-06",{"date":176,"type":177},"2025-12-09","ACTUAL",{"date":179,"type":177},"2022-11-08",{"date":181,"type":163},"2026-12-31",{"name":5,"class":6},4]