[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"maternal-obesity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:maternal-obesity":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,74,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100591534","the-developmental-origins-of-obesity-100591534",false,"NCT06981676","The Developmental Origins of Obesity","The Developmental Origins of Obesity: Effect of Maternal Supplementation With Polyunsaturated Fatty Acids and Insights Into Adipose and Immune Progenitor Cells","OMEGA-Stem","Inclusion Criteria:\n\n* First prenatal visit \\\u003C14 weeks gestation\n* Pregestational BMI between 18.5 and 24.9 for the NW groups and BMI \\>30 for the PGO groups,\n* To have singleton pregnancy,\n* ≥18 years of age and plan to deliver at the Hospital Clínico UC- Christus\n\nExclusion Criteria:\n\n* Preexisting diabetes\n* GDM\n* Preeclampsia,\n* Multiple gestations\n* Chronic cardio-respiratory disorder or neurological o genetic defects of the fetus\n* History of an eating disorder, food allergy,\n* Any high-risk pregnancy condition (MINSAL 2015)",true,"FEMALE","18 Years",{"count":21,"type":22},160,"ESTIMATED","INTERVENTIONAL",[25],"NA","Pregestational obesity (PGO, BMI ≥30) is a significant independent risk factor for the development of obesity in childhood and adolescence. Notably, elevated levels of IL-6 and leptin have been found in the cord blood of offspring born to women with PGO, along with increased body fat. Both our research and that of others have shown an upregulation of pro-inflammatory genes in cord blood monocytes and alterations in innate immune function, including a blunted response to pro-inflammatory stimuli. However, it remains unclear whether these effects are due to an altered immune response in differentiated immune cells or if they are programmed earlier in gestation, during the progenitor cell stage.\n\nLong-chain polyunsaturated fatty acids (LCPUFAs) are crucial for cellular function, acting as precursors to membrane components and signaling molecules involved in cardiovascular, metabolic, and immune processes. Modern dietary patterns have led to a relative deficiency in n-3 LCPUFAs, such as Docosahexaenoic acid (DHA) and Eicosapentaenoic acid (EPA). As a result, international health guidelines recommend LCPUFA supplementation during pregnancy. Studies have shown that increased intake of n-3 LCPUFAs during pregnancy exerts effective anti-inflammatory effects in the maternal circulation, adipose tissue, and placenta.\n\nThe recently completed MIGHT study (NCT02574767), which involved 1005 women with overweight or PGO, investigated the effects of DHA supplementation during pregnancy (200 mg vs. 800 mg\u002Fday). A subgroup of the newborns from this cohort also participated in the EpiFat study (NCT04249635), conducted by our team (2017-2021). The findings demonstrated that maternal DHA supplementation (800 mg\u002Fday) significantly reduced body fat and improved adipose metabolic markers in offspring at birth, with these effects persisting until 4 months of age. Additionally, the cord blood monocytes of PGO offspring exhibited increased expression of pro-inflammatory genes (IL-6, MCP-1, TNF-α, IL-8), but these effects were completely reversed in the offspring of DHA-supplemented women. These results provide strong evidence of pro-inflammatory programming in innate immune cells and adiposity in offspring of women with PGO, and show that maternal PUFA supplementation during pregnancy can reverse these early obesity biomarkers. However, it remains unclear whether these effects persist into early childhood (5 years of age), particularly in high-risk populations such as those born to women with PGO.\n\nMoreover, we hypothesize that maternal obesogenic signals during early embryonic development may affect the progenitor cells of adipocytes (mesenchymal stem cells, MSC) and monocytes (hematopoietic stem cells, HSC), potentially leading to long-term effects on the offspring.\n\nThis study hypothesizes that: \"Maternal obesity increases the risk of childhood obesity by programming adipose and immune progenitor cells, an effect that may be mitigated by maternal supplementation with polyunsaturated fatty acids during pregnancy.\" To test this hypothesis, we propose:\n\nA pilot clinical study to examine whether maternal PGO affects the lineage commitment, number, TLR4 signaling, and epigenetic markers (ChIP-seq) of monocyte (HSC) and adipocyte (MSC) progenitor cells, and whether maternal supplementation with PUFAs during pregnancy can modify these effects. The OMEGA Stem study will invite 160 healthy women (80 with normal weight and 80 with pregestational obesity) with singleton pregnancies to participate. Participants will receive either 600 mg\u002Fday of EPA\u002FDHA (1 capsule) or standard antenatal care. A trained midwife will enroll the women \\\u003C16 weeks of pregnancy, with data collection (sociodemographic information, clinical data and blood samples) at study initiation, 26-28 weeks, and at delivery. Neonatal body composition will be assessed by a trained midwife (24-48 hours after delivery) through anthropometric measurements and skinfold thickness, calculated using Catalano's formula.",[28,29],"Maternal Obesity","Obesity",[31,28,32,33,34],"Pregestational Obesity","Omega 3","PUFAs","LCPUFAs","RECRUITING","2025-05-12",{"date":38,"type":39},"2025-05-21","ACTUAL",{"date":41,"type":39},"2023-07-25",{"date":43,"type":22},"2027-03-30",{"name":45,"class":46},"Pontificia Universidad Catolica de Chile","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100586627","impact-of-maternal-body-mass-index-on-infant-hypoxic-events-at-time-of-delivery-cross-sectional-study-100586627","NCT06917833","Impact of Maternal Body Mass Index on Infant Hypoxic Events at Time of Delivery ,Cross-sectional Study.","Inclusion Criteria:\n\n1. Age of 18 - 40 years.\n2. Term pregnancy (37 weeks gestation or more)\n3. Singleton pregnancy\n4. Cephalic presentation at time of delivery\n5. In labour\n\nExclusion Criteria:\n\n1. Any medical disorders that affect neonatal outcomes (diabetes mellitus, hypertension, mixed connective tissue disorders)\n2. Scarred uterus (myomectomy, previous cesarean section)\n3. Macrosomic baby\\>4 kgs\n4. Condition jeopardizing the maternal or fetal life (for example: antepartum hemorrhage, pathological CTG, cord prolapse)\n5. Liquor abnormalities (oligohydramnios or polyhydramnios).\n6. Other indications for cesarean sections for example: placenta accreta spectrum\n7. Smokers.\n8. Any abnormalities in follow up of delivery regarding partogram.","40 Years",{"count":56,"type":22},544,"OBSERVATIONAL","Offspring from overweight or obese mothers appear to be at up to 38% increased risk of being admitted to the neonatal intensive care unit than the offspring of mothers with a normal BMI. In terms of Apgar scores at birth, babies of obese mothers have been reported to have a 31% excess risk of having a low Apgar score (defined at \\\u003C7 at 1 minute) . Infants born to obese mothers demonstrate a spectrum of outcomes, suggesting that there is a complex interplay of factors that defines the precise altered metabolic environment to which the fetus is exposed and that determines the risk of complications",[28,60],"Hypoxia Neonatal",[62,63],"maternal obesity","hypoxia neonatal","NOT_YET_RECRUITING","2025-04-04",{"date":67,"type":39},"2025-04-09",{"date":69,"type":22},"2025-04-20",{"date":71,"type":22},"2026-01-28",{"name":73,"class":46},"Ain Shams University",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":17,"sex":18,"minAge":81,"maxAge":54,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":47},"100455170","healthy-early-life-moments-in-singapore-100455170","NCT05207059","Healthy Early Life Moments in Singapore","HELMS","Inclusion Criteria:\n\n1. Women aged 21-40 years\n2. BMI 25-40 kg\u002Fm2\n3. Intention to reside in Singapore for the next 4 years\n4. Chinese, Malay, Indian or any combination of these 3 ethnic groups\n5. Planning to conceive within 1 year\n6. Able to understand English\n7. Able to provide written, informed consent\n\nExclusion Criteria:\n\n1. Currently pregnant\n2. Known type 1 or type 2 diabetes\n3. On any anticonvulsant medication in the past 1 month\n4. On any oral steroid in the past 1 month (e.g. Prednisolone, Prednisone, Deltasone, Prelone, Methyl Prednisolone, Medrol, Hydrocortisone, Cortef, Dexamethasone, Decadron)\n5. On any oral, implanted contraception or intrauterine contraceptive device (IUCD) in situ in the past 1 month\n6. On any fertility medication (e.g. hormones injection, IVF treatments) other than Clomiphene\u002F Letrozole in the past 1 month\n7. On HIV or Hepatitis B or C medication in the past 1 month.","21 Years",{"count":83,"type":22},500,[25],"This study aims to assess whether an integrated continuum of care from the preconception period, across maternity until the first 18 months of life, can promote maternal metabolic and mental health, as well as offspring health, among overweight and obese women.",[87,88,89,28],"Metabolic Disease","Mental Health Wellness 1","Lifestyle Risk Reduction",[29,91,92],"Mental health","Lifestyle intervention","2024-10-08",{"date":95,"type":39},"2024-10-10",{"date":97,"type":39},"2022-03-18",{"date":99,"type":22},"2028-12",{"name":101,"class":102},"KK Women's and Children's Hospital","OTHER_GOV",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":47},"100515056","early-life-feeding-exposure-and-infant-immune-and-health-status-100515056","NCT05986539","Early Life Feeding Exposure and Infant Immune and Health Status.","Mechanistic Effects of Early Life Feeding Exposure on Infant Inflammatory and Health Status","Inclusion Criteria:\n\n* Mother at least 18 years of age\n* Mother is in third trimester (week 27 of gestation) or biological infant is 5 weeks of age or younger\n* Mother plans to continue to provide your infant breastmilk (by breastfeeding or by pumping) for at least 18 weeks (4.5 months) from your delivery date or mother plans to continue to provide formula exclusively to infant for at least 18 weeks of life.\n* Mother lives within a 45-mile radius of Study Site, or is willing to deliver samples for visits 2, 4, and 6.\n* Mother willing to meet at (designated sample collection site) for visits 3 and 5 for sample collection and visit activities.\n* Mother willing to consent and comply with all aspects of the study protocol and methods, save the optional activities and optional sample collections.\n* Mother and infant are considered healthy by Principle Investigator.\n* For Formula Fed Group: Mother-Infant dyad is able to match to a Breastfed dyad using maternal BMI and infant sex.\n\nExclusion Criteria:\n\n* Mother or Infant have participated or are currently participating in an interventional drug or device (non-observational) research study before.\n* Mother reports that they, or the infant, have had an adverse effect during a venous blood collection.\n* Infant was born less than 36 weeks of gestation.\n* Infant or mother have health conditions that increase the risk of study procedures.",{"count":111,"type":22},60,"Background: Although breastfeeding has known protective effects, such as preventing childhood obesity, the specific mechanisms remain unclear. Idaho has a high breastfeeding initiation rate (92%) but a significant prevalence of childhood obesity (30.5% overweight\u002Fobese). Limited research exists on the impact of maternal inflammation, maternal body mass index (BMI), C-reactive protein (CRP), and interleukin-6 (IL-6) concentrations in breastmilk on infant health outcomes, especially in healthy full-term infants.\n\nObjective: This study aims to expand understanding of the role of maternal inflammation on breastmilk composition and its effect on infant immune development. The investigators seek to investigate the relationship between maternal health status, breastmilk inflammatory concentrations, and balanced immune development in infants. Additionally, the investigators aim to explore the potential influence of early diet exposure, including maternal inflammatory status, on the risk of obesity and other inflammatory conditions.\n\nMethods: Healthy full-term infants (breastfed\u002Fformula-fed) and their mothers will be recruited. Maternal inflammation markers (BMI, CRP, IL-6) and immune markers in infants will be analyzed. Flow cytometry will assess immune populations. Correlations between maternal systemic inflammation, infant inflammation, and breastmilk inflammatory markers will be examined for breastfeeding mothers.\n\nOutcomes: The investigators hypothesize breastfed infants will display a more favorable anti-inflammatory profile. This study will identify factors influencing immune development and potential pathways linking early-life exposures to long-term health outcomes. Findings will inform strategies for promoting balanced immune development and elucidate the role of early diet exposure, including maternal inflammation, as a protective or risk factor for obesity and inflammatory conditions.",[114,28,115,116],"Maternal Behavior","Breast Milk Collection","Infant Development","2024-07-24",{"date":119,"type":39},"2024-07-26",{"date":121,"type":39},"2024-01-12",{"date":123,"type":22},"2025-04-30",{"name":125,"class":46},"University of Idaho"]