[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530294":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":25,"responsibleParty":36,"collaborators":25,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":25,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":25,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":25},{"fullName":5,"class":6},"University of Naples","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CONTROLS","PLACEBO_COMPARATOR","Participants in the control arm will undergo a traditional weaning process. This involves primarily the use of industrial baby foods, with a gradual introduction of fresh foods. Legumes will be introduced at around 7-8 months, and fresh fish will be incorporated into the diet after one year of age.",[13],"Dietary Supplement: Weaning by Mediterranean Diet",{"label":15,"type":16,"description":17,"interventionNames":18},"Treated","EXPERIMENTAL","Participants in the experimental arm will follow a Mediterranean Diet (MD) weaning schema. This approach includes exclusively fresh foods that are part of the traditional MD, modified to suit infants. Key elements of this diet include:\n\n* Seasonal fruit and vegetables, such as broccoli and cauliflower, served as purees from the beginning of weaning.\n* A variety of fresh blue fish (e.g., anchovies, mackerel, flag fish, cod, sole) introduced at 7 months, seasoned with garlic and cherry tomatoes.\n* Use of spices and herbs like thyme, marjoram, rosemary, parsley, garlic, and onion to flavor meals.\n* Exclusion of salt; meals are instead enhanced with 2 g of Parmesan cheese for taste.\n* Avoidance of sweets.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Weaning by Mediterranean Diet","Introduce solid foods typical of the Mediterranean Diet at weaning of infants",[9,15],null,[27,32],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"LUIGI GRECO","CONTACT","3341587925","ydongre@unina.it",{"name":33,"role":29,"phone":34,"phoneExt":25,"email":35},"RENATA AURICCHIO","+393392507648","rRenata Auricchio \u003Cr.auricchio@unina.it>",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Luigi Greco","Professor of Pediatrics","100530294","phase-3-preventing-celiac-disease-by-weaning-with-mediterranean-diet-100530294",false,"NCT06184906","Preventing Celiac Disease by Weaning With Mediterranean Diet","PEMED","Inclusion Criteria:\n\n* \\- Healthy newborns with a birth weight greater than 2000 grams.\n* Residence in Municipality 8, Piscinola-Scampia.\n\nExclusion Criteria:\n\n* \\- Newborns suffering from severe prematurity.\n* Newborns with congenital malformations.\n* Newborns afflicted by severe diseases.","ALL","1 Month","10 Months",{"count":51,"type":52},3200,"ESTIMATED","INTERVENTIONAL",[55],"PHASE3","Background: The introduction of solid foods in alignment with the Mediterranean Diet (MD) post-exclusive milk feeding has been demonstrated to cultivate a lasting affinity for healthy eating during infancy and childhood. Despite this, access to healthy diets remains a challenge for numerous children, particularly in underserved areas. The clinical trial under discussion is set in Scampia, a municipality in Naples, Italy, known for its dense population and socio-economic challenges. This trial, utilizing the Family Pediatrician (FP) system, aims to promote MD nutrition among children in Scampia to potentially prevent or reduce chronic childhood diseases.\n\nStudy Design: In this pragmatic trial, FPs are utilized as the unit for randomization to administer the intervention. The intervention group will be introduced to an intensified MD-based diet from weaning, incorporating adult-type MD foods, while the control group will follow standard regional dietary guidelines. Dietary adherence and health outcomes are to be periodically monitored, and genetic and microbiome analyses will be conducted using collected saliva and stool samples. Incorporating a Bayesian group sequential design, this trial is structured to conduct interim analyses for efficacy, aligning with local healthcare systems for optimal resource allocation.\n\nConclusion: The study is poised to be methodologically innovative and socially impactful, utilizing existing healthcare frameworks to enhance childhood nutrition in challenging environments. Outcomes from this trial are expected to provide valuable insights into the effects of MD-based nutrition on child health and potentially serve as a model for promoting healthier diets in urban suburbs globally.",[58],"Weaning Failure",[60,61,62],"Infant Weaning","Mediterranean Diet","Celiac Disease","NOT_YET_RECRUITING","2024-05-07",{"date":66,"type":67},"2024-05-08","ACTUAL",{"date":69,"type":52},"2024-06-15",{"date":71,"type":52},"2030-12-31",{"name":5,"class":6}]