[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infant-behaviour\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infant-behaviour":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100563303","intervention-based-on-the-mediterranean-diet-during-pregnancy-and-the-first-two-years-for-the-improvement-of-neurological-development-100563303",false,"NCT06614413","Intervention Based on the Mediterranean Diet During Pregnancy and the First Two Years for the Improvement of Neurological Development","Randomized Controlled Clinical Trial: Dietetic-nutritional Intervention Based on the Mediterranean Diet During Pregnancy and the First Two Years, First Thousand Days, for the Improvement of Neurological Development","CONMED","1. Inclusion Criteria:\n\n   a. Fluency in the Spanish language, singleton pregnancy\n2. Exclusion Criteria:\n\n   1. Children conceived with assisted reproduction techniques\n   2. Fetal anomalies and congenital infections\n   3. Neonatal anomalies diagnosed after birth\n   4. Intellectual development disorder, due to clinical judgment, inability to attend visits\n   5. Participation in another controlled trial\n   6. Vegetarian diet",true,"ALL",{"count":20,"type":21},534,"ESTIMATED","INTERVENTIONAL",[24],"NA","The main objective is to evaluate the effect of the Mediterranean diet during pregnancy and the first two years of the child\\'s life on the child\\'s neurodevelopment and behavior (externalizing and internalizing disorders) measured at one and a half and two years. Secondary objectives are to evaluate the effect of the Mediterranean diet on: body composition at two years of age in infants (densitometry) and of the mother at 3 months postpartum, the incidence of allergic disease in infants, the fetal and infant ́s growth and metabolic risk in the mother during pregnancy and in the boy\u002Fgirl at two years (fasting glucose: insulin, HOMA), LDL and HDL cholesterol, and micronutrient status (iron, calcium, phosphorus, magnesium, sodium, potassium, chloride, selenium, zinc and LCPUFAs).\n\nRandomized controlled clinical trial with a 1:1 ratio, parallel and open label. Group 1: Mother-child binomial with nutritional intervention; Group 2: Mother-child binomial as a control group (with follow-up without intervention).\n\nAssuming a loss of 25% (10% at follow-up, 15% failure of nutritional intervention) we would need a sample size of 267 patients per group. 1. Evaluation of neurodevelopment using the Bayleys scale version -III, at 2 years of age. 2.\n\nBehavioral assessment CBCL at 1.5 and two years and BRIEF-P at two years.",[27,28,29,30],"Diet, Mediterranean","Pregnancy Related","Child Development","Infant Behaviour","NOT_YET_RECRUITING","2024-09-25",{"date":34,"type":35},"2024-09-26","ACTUAL",{"date":37,"type":21},"2024-10-01",{"date":39,"type":21},"2029-02",{"name":41,"class":42},"Hospital Universitario La Paz","OTHER"]