[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Idaho\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":127},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,72,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100586771","impact-of-vitamin-d-supplements-on-mental-health-and-milk-composition-in-mothers-living-in-idaho-100586771",false,"NCT06919718","Impact of Vitamin D Supplements on Mental Health and Milk Composition in Mothers Living in Idaho","Effects of Maternal Stress on Human Milk Composition and Subsequent Infant Outcomes","Inclusion Criteria:\n\n* Mothers (\\>\u002F= 18 years of age) of newborn infants (within first 4 months postpartum) in Idaho\n\nExclusion Criteria:\n\n* Mothers (\\\u003C18 years of age) of newborn infants (within first 4 months postpartum)\n* Infants not anticipated to survive \\>72 hours",true,"FEMALE","18 Years","64 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","Mothers of preterm infants experience exaggerated emotional stressors compared to those typically associated with new motherhood, making these women particularly vulnerable to postpartum depression. As many as 70% of mothers of preterm infants experience postpartum depression compared to only 12.5% of those delivering full-term infants. Increased stress and depression during this critical period are detrimental because they hamper a mother's ability to care for her infant and are associated with increased neonatal sepsis and mortality, decreased neonatal growth, and delayed motor and cognitive development. Postpartum depression is also associated with excessive maternal weight gain and risk for metabolic diseases, anxiety, and sleep disturbances. Stress in breastfeeding mothers can also alter circulating concentrations of some bioactive components (e.g., immunoglobulins, cortisol) that can transfer into milk. As such, understanding factors predisposing these vulnerable women to extreme levels of stress and finding ways to lower this stress and lessen its negative health outcomes on mothers and infants are important public health challenges. The March of Dimes estimates that 8.5% of births in Idaho are preterm, making this topic particularly relevant for Idaho women. Risk factors for postpartum depression in mothers delivering term or preterm infants are complex, but maternal nutrient deficiencies may be involved. Vitamin D status, for instance, is inversely correlated with risk of postpartum depression in women delivering term infants. However, vitamin D interventions have yielded inconsistent results, perhaps due to confounding impacts of geographic location, skin color, and endogenous vitamin D synthesis. Endogenous vitamin D synthesis requires cutaneous sunlight exposure, placing Idaho women at even greater risk of vitamin D deficiency - particularly in the winter when days are extremely short (only 7 hr on the winter solstice). The impact of maternal vitamin D supplementation during lactation on infant variables (e.g., vitamin D status) has been examined. However, its effect on maternal mental health has not been rigorously studied - let alone in the 'frontier and remote' (FAR) rural West, including Idaho, with short periods of wintertime sunlight and poor access to healthcare. Our long term goal is to develop interventions to improve maternal and infant health in Idaho - particularly in the context of preterm births. The overall primary objective of this proposal is to determine if maternal vitamin D supplementation improves vitamin D status and mental health in Idahoan mothers of preterm infants. Our central hypothesis is that vitamin D supplementation improves vitamin D status and reduces stress and other indicators of poor postpartum maternal mental health in Idaho women delivering preterm infants. Secondarily, we will assess the effects of maternal vitamin D supplementation on human milk composition.",[28],"Maternal Stress","RECRUITING","2025-07-31",{"date":32,"type":33},"2025-08-01","ACTUAL",{"date":35,"type":33},"2024-12-04",{"date":37,"type":22},"2027-05-31",{"name":39,"class":40},"University of Idaho","OTHER",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":14,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100425559","maternal-stress-on-human-milk-and-infant-outcomes-100425559","NCT04821544","Maternal Stress on Human Milk and Infant Outcomes","Inclusion Criteria:\n\n* Mothers of newborn infants at Kootenai Health NICU and the Palouse region\n\nExclusion Criteria:\n\n\\-","50 Years",{"count":50,"type":22},500,[25],"The overarching purpose of this study is to determine if a modified 8-week mindfulness-based intervention (with a focus on self-compassion; MBSC) or 8 weeks of 2000 IU vitamin D supplementation will reduce stress and increase self-compassion in mothers of preterm infants and beneficially modify the human milk produced, and subsequently improve infant health.",[54,55],"Postpartum Depression","Preterm Labor",[57,58,59,60,61,62],"Maternal stress","Mindfulness","Human milk bioactives","Infant metabolome","Maternal transcriptome","Infant transcriptome","2025-05-16",{"date":65,"type":33},"2025-05-18",{"date":67,"type":33},"2021-05-01",{"date":69,"type":22},"2027-06-30",{"name":39,"class":40},1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":16,"sex":79,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":41},"100571531","trout-consumption-in-young-children-and-families-and-brain-health-100571531","NCT06721468","Trout Consumption in Young Children and Families and Brain Health","Increasing Trout Consumption in Young Children and Families for Cognitive and Mental Health Benefit","Inclusion Criteria:\n\n* Objective 1: Children 3-6 years of age, adults age 18+, English speaking\n* Objective 2: Children 4-6 years of age, English speaking\n* Objective 3: Children 4-9 years of age AND parent\u002Fguardian, English or Spanish speaking, access to internet, currently eat fish less than twice per week\n\nExclusion Criteria:\n\n* allergy or dietary restriction preventing consuming fish","ALL","3 Years",{"count":82,"type":22},99,[25],"Regular fish consumption may support brain health. Trout lines developed in Idaho contain higher levels of omega-3 fatty acids, nutrients important for human cognition and mental wellbeing. Developed to support aquaculture sustainability, consumer preferences and human health benefits of these fish are unknown. The long-term goal of this project is to utilize nutrition education strategies to increase adult and child consumption of fish to improve brain health as measured by cognitive and emotional wellbeing. Research objectives and activities include, (1) adult and child consumer panels to provide sensory evaluation on three strains of trout, (2) effects of repeated exposure (RE) and child-centered nutrition phrases (CCNP) on eating behaviors and brain health will be determined using one control and two treatment groups of children in childcare settings, (3) effects of nutrition education, incorporating CCNP and fish preparation techniques, and RE targeting family meals on eating behaviors of children and brain health of adults and children will be determined using four treatment groups in the home setting.",[86,87],"Cognitive Change","Well-Being, Psychological",[89,90,91,92,93,94],"Trout","Children","Child-Centered Nutrition Phrases","Cognition","Emotional well-being","Sensory evaluation","2024-12-03",{"date":97,"type":33},"2024-12-06",{"date":99,"type":33},"2024-05-13",{"date":101,"type":22},"2027-12-31",{"name":39,"class":40},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":71},"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,"OBSERVATIONAL","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.",[115,116,117,118],"Maternal Behavior","Maternal Obesity","Breast Milk Collection","Infant Development","2024-07-24",{"date":121,"type":33},"2024-07-26",{"date":123,"type":33},"2024-01-12",{"date":125,"type":22},"2025-04-30",{"name":39,"class":40},""]