[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532177":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":50,"centralContacts":57,"locations":65,"responsibleParty":83,"collaborators":85,"id":89,"slug":36,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":36,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":36,"enrollmentInfo":98,"targetDuration":36,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":68,"whyStopped":36,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Weill Medical College of Cornell University","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Referral Arm","ACTIVE_COMPARATOR","CHW will contact participants with GDM from communities in the referral arm beginning at 6 weeks postpartum to arrange a convenient time for a home visit within the first postpartum year. During the home visit, CHW will provide 1) T2DM education and 2) referral to the postnatal clinic at a government hospital for T2DM screening.",[13],"Behavioral: Clinic Based Screening",{"label":15,"type":16,"description":17,"interventionNames":18},"Home Testing Arm","EXPERIMENTAL","CHW will contact participants with GDM from communities in the home-based testing arm beginning at 6 weeks postpartum to arrange a convenient time for a home visit within the first postpartum year. During the home visit, CHW will provide 1) T2DM education, and 2) offer home-based OGTT.",[19],"Behavioral: Home Based Testing",{"label":21,"type":6,"description":22,"interventionNames":23},"Protein-fiber food supplement Before Meals","Food order nutritional intervention, protein-fiber supplement is given before meals for 4 days, then a 4 day washout period, then given after meals for 4 days in a subgroup of women without type 2 diabetes at the postpartum follow-up.",[24],"Dietary Supplement: Food order nutritional intervention before meals",{"label":26,"type":6,"description":27,"interventionNames":28},"Protein-fiber food supplement after meals","Food order nutritional intervention, protein-fiber supplement is given after meals for 4 days, then a 4 day washout period, then given before meals for 4 days in a subgroup of women without type 2 diabetes at the postpartum follow-up.",[29],"Dietary Supplement: Food order nutritional intervention after meals",[31,37,41,46],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BEHAVIORAL","Home Based Testing","Community Health Workers (CHWs) will offer at home OGTT testing to women within the first postpartum year, as well as Type 2 Diabetes education.",[15],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Clinic Based Screening","Community Health Workers (CHWs) will offer referral to clinic based OGTT testing to women within the first postpartum year, as well as Type 2 Diabetes education.",[9],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":36},"DIETARY_SUPPLEMENT","Food order nutritional intervention before meals","Protein-fiber food supplements (e.g. laddoos \u002Fkhakras\u002Fsavory snack) will be provided. Participants will be randomized to consume the supplement before meals (protein-fiber first) or consume it after meals (protein-fiber last). After 4 days, there will be a 4-day washout period and participants will switch groups.",[21],{"type":42,"name":47,"description":48,"armGroupLabels":49,"otherNames":36},"Food order nutritional intervention after meals","Protein-fiber food supplements (e.g. laddoos \u002Fkhakras\u002Fsavory snack) will be provided. Participants will be randomized to consume the supplement after meals (protein-fiber first) or consume it before meals (protein-fiber last). After 4 days, there will be a 4-day washout period and participants will switch groups.",[26],[51,55],{"name":52,"affiliation":53,"role":54},"Jyoti Mathad, MD, MSc","Weill Cornell Medicine Center for Global Health","PRINCIPAL_INVESTIGATOR",{"name":56,"affiliation":53,"role":54},"Radhika Sundararajan, MD, PhD",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":36,"email":62},"Jyoti S Mathad, MD, MSc","CONTACT","646-962-8140","jsm9009@med.cornell.edu",{"name":56,"role":60,"phone":61,"phoneExt":36,"email":64},"ras9199@med.cornell.edu",[66],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Deep Griha Society","RECRUITING","Pune","Maharashtra","411001","India",{"type":74,"coordinates":75},"Point",[76,77],73.85535,18.51957,{"lat":77,"lon":76},[80],{"name":81,"role":60,"phone":36,"phoneExt":36,"email":82},"Ashlesha Onawale","ashlesha.onawale@deepgriha.org",{"type":84,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[86],{"name":87,"class":88},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100532177",false,"NCT06209411","Community Health Worker-Led Postpartum Diabetes Screening","A Type 2 Hybrid Effectiveness-Implementation Trial of Community Health Workers to Improve Screening for Postpartum Diabetes in Urban Slums of India","Inclusion Criteria:\n\nPregnant Women:\n\n* Pregnant woman residing in one of pre-selected slum communities\n* 18 years or older\n* ≥ 24 weeks gestational age (as determined by self-reported last menstrual period or ultrasound)\n* Meet or exceed the threshold for GDM as determined by the CHW-delivered fasting OGTT\n* Agrees to study procedures, including in-person visits with the CHW postpartum if they are diagnosed with GDM\n\nCommunity Health Workers:\n\n* 18 years or older\n* Willingness to participate in study procedures and recruit eligible pregnant women\n* Agreement with goals of the study\n* Resides in one of the study communities\n* Willing to participate in surveys and interviews\n\nClinicians:\n\n* 18 years or older\n* Diabetes or obstetrics physicians\n* In a patient-facing position for over 1 year\n\nMinistry of Health Officials\n\n* 18 years or older\n* Employed by the Ministry of Health and Family Welfare, Maternal Health Division\n\nExclusion Criteria:\n\nPregnant Women:\n\n* Preexisting diabetes diagnosis prior to current pregnancy\n* Unable to tolerate food\u002F drink and remain fasting for 8 hoursUnwilling or unable to participate in study procedures\n* Unwilling or unable to provide informed consent\n\nCHW, Clinicians, Ministry of Health Officials\n\n1. Unwilling or unable to participate in study procedures\n2. Unwilling or unable to provide informed consent",true,"FEMALE","18 Years",{"count":99,"type":100},330,"ESTIMATED","INTERVENTIONAL",[103],"NA","Women who experience gestational diabetes are at high risk of developing type 2 diabetes mellitus in the postpartum period-especially in low- and middle-income countries like India where the burden of diabetes is high and disproportionately affects women- but few receive the World Health Organization-recommended postpartum diabetes screening test. The investigators propose a cluster randomized clinical trial to determine whether community health worker-administered, home-based testing increases uptake of postpartum diabetes screening in the urban slums of Pune, India. The proposed study will provide an acceptable and scalable model that can be used to improve postpartum diabetes screening in other low-income settings, thereby improving early detection of diabetes in women and preventing morbidity and mortality in this high-risk population. A substudy will also test the effectiveness of a timed protein-fiber supplement in glucose control.",[106,107],"Diabetes Mellitus, Type 2","Gestational Diabetes",[109,110],"Community Health Workers","Type 2 Hybrid Effectiveness-Implementation Trial","2026-05-04",{"date":113,"type":114},"2026-05-06","ACTUAL",{"date":116,"type":114},"2024-06-13",{"date":118,"type":100},"2027-10",{"name":5,"class":6},1]