[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550299":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":33,"responsibleParty":54,"collaborators":57,"id":62,"slug":12,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":12,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":12,"enrollmentInfo":71,"targetDuration":12,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":86,"whyStopped":12,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Indiana University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","This arm consists of standard of care counseling for diet and exercise.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"GDM Prevention Program","EXPERIMENTAL","This arm consists of a more intensive exercise and monitoring program. .",[18],"Behavioral: GDM Prevention Program",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"BEHAVIORAL","Participants will receive hybrid and group monthly contacts with registered dieticians and lifestyle coaches. Participants will attend monthly in-person physical activity sessions.",[14],[25],{"name":26,"affiliation":5,"role":27},"David M Haas, MD","PRINCIPAL_INVESTIGATOR",[29],{"name":26,"role":30,"phone":31,"phoneExt":12,"email":32},"CONTACT","317-880-3960","dahaas@iu.edu",[34],{"facility":35,"status":12,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Sidney and Lois Eskenazi Hospital","Indianapolis","Indiana","46202","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-86.15804,39.76838,{"lat":45,"lon":44},[48,52],{"name":49,"role":30,"phone":50,"phoneExt":12,"email":51},"Kathleen Flannery","317-880-3961","kamaflan@iu.edu",{"name":53,"role":27,"phone":12,"phoneExt":12,"email":12},"David M Haas, MD, MS",{"type":27,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"David Haas","Munsick Professor of Obstetrics and Gynecology",[58,60],{"name":59,"class":6},"Northeastern University",{"name":61,"class":6},"University of Texas","100550299",false,"NCT06445270","Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals","Evidence-informed Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals","Inclusion Criteria:\n\n* Gestational age less or equal to 16 + 6 weeks confirmed via ACOG dating guidelines AND one of the following\n* 35 years of age or older\n* Family history of first degree relative with diabetes mellitus\n* Body Mass Index (BMI) greater than or equal to 30\n* Hemoglobin A1c value between 5.9% to 6.4%\n\nExclusion Criteria:\n\n* Multiple gestations\n* Current diagnosis of Type 1 or 2 diabetes mellitus including a diagnosis during this pregnancy\n* Pre-pregnancy chronic (\\>2 weeks) usage of systemic steroids (inhaled and short term usage acceptable)\n* Planned pregnancy termination\n* Currently taking or took 3 months prior to conception Metformin\n* Unable to provide informed consent in English or Spanish\n* Major fetal anomalies listed below that are known prior to enrollment.\n\nMajor fetal anomalies:\n\n* Congenital diaphragmatic hernia\n* Congenital cystic adenomatoid malformation\n* Pleural effustions\n* Chylothorax\n* Bronchogenic cyst\n* Bronchopulmonary sequestration\n* Anomalous pulmonary venous return\n* Tricuspid atresia\n* Mitral atresia\n* Double right ventricle\n* Ebstein's malformation\n* Pulmonary atresia\n* Hypoplastic left heart syndrome\n* Aortic coarctation\n* Fetal arrhythmias\n* Transposition of the great vessels\n* Tetrology of Fallot\n* Double outlet right ventricle\n* Aortic stenosis\n* Holoprosencephaly\n* Anencephaly\n* Dandy-Walker malformation or variant\n* Septo-optic dysplasia\n* Neural tube defect\n* Vein of Galen aneurysm\n* Bilateral renal agenesis\n* Cystic renal disease\n* Obstructive uropathy\n* Horseshoe kidney\n* Megacystis microcolon\n* Cloacal abnormality\n* Achondrogenesis\n* Thanatophoric dysplasia\n* Thoracic dysplasia\n* Osteogenesis imperfecta\n* Short rib polydacyly\n* Any skeletal defect with suspected small thorax\n* Hypophosphatemia\n* Any karyotypic abnormality\n* Any suspected genetic syndrome\n* Cleft lip\u002Fpalate\n* Micrognathia\n* Hydrops\n* Fetal anemia (\\\u003C35% on cordocentesis)\n* Neck mass\n* Gastroschsis\n* Omphalocele",true,"FEMALE","14 Years",{"count":72,"type":73},100,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this study is assess the impact of a higher intensity dietary and activity counseling program to improve blood sugar control and reduce the chance of developing gestational diabetes (GDM) as compared to the current standard diet and activity counseling.",[79,80],"Gestational Diabetes","Pregnancy Complications",[82,83,84,85],"gestational diabetes","prevention","pregnancy","continuous glucose monitor","NOT_YET_RECRUITING","2025-12-10",{"date":89,"type":90},"2025-12-18","ACTUAL",{"date":92,"type":73},"2026-08",{"date":94,"type":73},"2031-12",{"name":5,"class":6},1]