[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100436241":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":10,"responsibleParty":33,"collaborators":10,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":43,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":10,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":67,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":10},{"fullName":5,"class":6},"University of Pavia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dyads",null,"Mother\u002Finfant pairs will be evaluated for anthropometric parameters, prenatal (dietary\u002Flifestyle maternal factors)\u002Fpostnatal determinants (type of feeding, sleep patterns, speed of growth) before discharge and after different follow-up after birth. Infant urinary and stool samples will be collected and stored. The infant adiposity rebound will be monitored.",[13],"Other: Evaluation of microbiome and maternal\u002Finfant lifestyle",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Evaluation of microbiome and maternal\u002Finfant lifestyle","Identification of the longitudinal interplay between the intestinal microbiome and infant\u002Fmaternal nutritional and lifestyle habits, environmental factors exposure and anthropometric measurements, in children with adiposity rebound vs children with early adiposity rebound.",[9],[20],{"name":21,"affiliation":5,"role":22},"Rachele De Giuseppe, PhD","PRINCIPAL_INVESTIGATOR",[24,29],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Ilaria Di Napoli, Dr","CONTACT","+390382987536","ilaria.dinapoli@unipv.it",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Hellas Cena, Prof","+390382987542","hellas.cena@unipv.it",{"type":34,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100436241","limit-early-adiposity-rebound-in-children-100436241",false,"NCT04960670","LIMIT Early Adiposity Rebound in Children","LIMIT (LIfestyle and Microbiome InTeraction) Early Adiposity Rebound in Children","LIMIT","* Inclusion criteria: i) Infants of both sexes born to vaginal\u002Fcaesarean delivery; ii) Gestational age: 37-42 weeks; iii) Italian-speaking parent; iv) 7 Ability of the parent\u002Fguardian to give informed consent; v) Ability of the mother to answer questionnaires.\n* Exclusion Criteria: i) Infants with genetic\u002Fcongenital diseases; ii) Infants selected for another clinical study; iii) Infants hospitalized immediately after birth; iv) Presence of gestational diabetes; v) Presence of hyperthyroidism during pregnancy; vi) Parents refusing to sign the informed consent.",true,"ALL","1 Day","48 Months",{"count":48,"type":49},150,"ESTIMATED","OBSERVATIONAL","Childhood obesity is a strong predictor of adult obesity with health and economic consequences for the individual and society. Adiposity rebound (AR) is a rise in the Body Mass Index occurring between 3-7 years. Early adiposity rebound (EAR) occurs at a median age of 2 years and is a risk factor for later obesity. Events happening in \"the first 1,000 days\" play a role in obesity development. One of the key elements in this crucial time window is the gut microbiome, a highly dynamic organ that is sensitive to environmental exposure being linked to obesity development. Prenatal (dietary\u002Flifestyle maternal factors and environmental exposure) and postnatal determinants (the type of feeding, sleep patterns, speed of growth) and environmental obesogenic pollutants may influence the infant microbial colonization, thus increasing the risk of EAR onset.\n\nLIMIT will holistically identify the longitudinal interplay between the intestinal microbiome and infant\u002Fmaternal nutritional and lifestyle habits, environmental factors exposure and anthropometric measurements, in children with AR vs EAR, driving new mechanistic insights to create an EAR predictive model.\n\nThe study will evaluate a group of 150 mother-infant pairs, during the first four years of life at different follow-up.",[53,54,55],"Childhood Obesity","Life Style","Intestinal Microbiome",[57,58,59,60,61,62,63,64,65,66],"childhood obesity","maternal lifestyle","gut microbiome","adiposity rebound","fetal programming","first thousand days","pregnancy","breastfeeding","children nutrition","endocrine disruptors chemicals","NOT_YET_RECRUITING","2021-07-01",{"date":70,"type":71},"2021-07-14","ACTUAL",{"date":73,"type":49},"2021-12-01",{"date":75,"type":49},"2026-12-31",{"name":5,"class":6}]