protocolSection identificationModule nctId: NCT06317883, orgStudyIdInfo id: CORALS, briefTitle: Childhood Obesity Risk Assessment Longitudinal Study, acronym: CORALS, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2019-05-27, primaryCompletionDateStruct date: 2032-07-14, completionDateStruct date: 2032-07-14, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Consorcio Centro de Investigación Biomédica en Red (CIBER), class: OTHER_GOV, collaborators name: Instituto de Salud Carlos III, collaborators name: Maimónides Biomedical Research Institute of Córdoba, collaborators name: Universidad de Córdoba, collaborators name: Institut Investigacio Sanitaria Pere Virgili, collaborators name: University Rovira i Virgili, collaborators name: Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), descriptionModule briefSummary: Childhood obesity is a major public health problem worldwide. Europe has a high prevalence of obesity, which is accentuated in Mediterranean countries. Spain has a high prevalence of both overweight (percentage: 21.5 in boys and 22.2 in girls) and obesity (percentage: 10.6 in boys and 11.8 in girls) in children aged 6-9 years.From childhood, obesity is associated with an increased risk of diseases such as insulin resistance, type 2 diabetes, hypertension, metabolic syndrome, musculoskeletal problems, sleep disorders and mental health problems. Obesity is a complex, multi-causal problem involving individual risk factors such as behavior and genetics. Behavioral factors include diet, physical activity, sedentary lifestyle, sleep, and others. It is therefore important to study each of the individual risk factors for obesity. There are few large sample studies in European/Spanish children and no longitudinal studies estimating the incidence of obesity in preschool children based on exposure to different risk factors, considering not only the effect of food consumption but also dietary habits and patterns.The aim of the present study is to identify risk factors for childhood obesity through long-term longitudinal follow-up., conditionsModule conditions: Child Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1508, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Assessment of dietary intake and habits, primaryOutcomes measure: Assessment of physical activity, sedentary behavior and sleep pattern, primaryOutcomes measure: Early risk factors, primaryOutcomes measure: Body composition: Height, primaryOutcomes measure: Body composition: Weight, primaryOutcomes measure: Body composition: Body mass index, primaryOutcomes measure: Body composition: Waist circumference, primaryOutcomes measure: Psychosocial and neuropsychological behavioral assessment, primaryOutcomes measure: Verbal fluency, primaryOutcomes measure: Muscular strength, primaryOutcomes measure: Cardiorespiratory endurance, secondaryOutcomes measure: Association between genetic polymorphisms, metabolomic and metagenomic profiles with the development of obesity., secondaryOutcomes measure: Body composition: Waist height, secondaryOutcomes measure: Body composition: Fat mass, secondaryOutcomes measure: Body composition: Fat mass index, secondaryOutcomes measure: Body composition: Fat-free mass, secondaryOutcomes measure: Body composition: Total body water, secondaryOutcomes measure: Systolic blood pressure measurement, secondaryOutcomes measure: Diastolic blood pressure measurement, secondaryOutcomes measure: Heart rate measurement, secondaryOutcomes measure: Hematological analysis: Hemoglobine, secondaryOutcomes measure: Hematological analysis: Hematocrite, secondaryOutcomes measure: Hematological analysis: Erythrocytes, secondaryOutcomes measure: Hematological analysis: Mean corpuscular volume, secondaryOutcomes measure: Hematological analysis: Mean corpuscular hemoglobin, secondaryOutcomes measure: Hematological analysis: Mean corpuscular hemoglobin concentration, secondaryOutcomes measure: Hematological analysis: Red cell blood distribution width, secondaryOutcomes measure: Hematological analysis: White blood cells, secondaryOutcomes measure: Hematological analysis: Neutrophils, secondaryOutcomes measure: Hematological analysis: Lymphocytes, secondaryOutcomes measure: Hematological analysis: Monocytes, secondaryOutcomes measure: Hematological analysis: Eosinophils, secondaryOutcomes measure: Hematological analysis: Basophiles, secondaryOutcomes measure: Hematological analysis: Platelets, secondaryOutcomes measure: Hematological analysis: Mean platelet volume, secondaryOutcomes measure: Biochemical analysis: Glucose, secondaryOutcomes measure: Biochemical analysis: Bilirubin, secondaryOutcomes measure: Biochemical analysis: Creatinine, secondaryOutcomes measure: Biochemical analysis: Urate, secondaryOutcomes measure: Biochemical analysis: Urea, secondaryOutcomes measure: Biochemical analysis: Total protein, secondaryOutcomes measure: Biochemical analysis: Aspartate aminotransferase, secondaryOutcomes measure: Biochemical analysis: Alanine aminotransferase, secondaryOutcomes measure: Biochemical analysis: Gamma-glutamyl transferase, secondaryOutcomes measure: Biochemical analysis: Alkaline phosphatase, secondaryOutcomes measure: Biochemical analysis: Total cholesterol, secondaryOutcomes measure: Biochemical analysis: High density lipoproteins, secondaryOutcomes measure: Biochemical analysis: Non-HDL cholesterol, secondaryOutcomes measure: Biochemical analysis: Low density lipoproteins, secondaryOutcomes measure: Biochemical analysis: Apolipoprotein A1, secondaryOutcomes measure: Biochemical analysis: Apolipoprotein B, secondaryOutcomes measure: Biochemical analysis: Calcium, secondaryOutcomes measure: Biochemical analysis: Potassium, secondaryOutcomes measure: Biochemical analysis: Sodium, secondaryOutcomes measure: Biochemical analysis: Phosphorus, secondaryOutcomes measure: Biochemical analysis: Iron, secondaryOutcomes measure: Biochemical analysis: Magnesium, secondaryOutcomes measure: Biochemical analysis: Zinc, secondaryOutcomes measure: Biochemical analysis: Insulin, secondaryOutcomes measure: Biochemical analysis: Insulin resistance, secondaryOutcomes measure: Biochemical analysis: C-reactive protein, secondaryOutcomes measure: Biochemical analysis: Tumor necrosis factor alpha, secondaryOutcomes measure: Biochemical analysis: Adiponectin, secondaryOutcomes measure: Biochemical analysis: Energy, secondaryOutcomes measure: Biochemical analysis: Carbohydrates, secondaryOutcomes measure: Biochemical analysis: Sugars, secondaryOutcomes measure: Biochemical analysis: Fiber, secondaryOutcomes measure: Biochemical analysis: Polysaccharides, secondaryOutcomes measure: Biochemical analysis: Total fat, secondaryOutcomes measure: Biochemical analysis: Saturated fatty acids, secondaryOutcomes measure: Biochemical analysis: Monounsaturated fatty acids, secondaryOutcomes measure: Biochemical analysis: Polyunsaturated fatty acids, secondaryOutcomes measure: Biochemical analysis: Vitamin B1, secondaryOutcomes measure: Biochemical analysis: Vitamin B2, secondaryOutcomes measure: Biochemical analysis: Vitamin B3, secondaryOutcomes measure: Biochemical analysis: Vitamin B6, secondaryOutcomes measure: Biochemical analysis: Vitamin B9, secondaryOutcomes measure: Biochemical analysis: Vitamin B12, secondaryOutcomes measure: Biochemical analysis: Vitamin C, secondaryOutcomes measure: Biochemical analysis: Vitamin A, secondaryOutcomes measure: Biochemical analysis: Vitamin D, secondaryOutcomes measure: Biochemical analysis: Vitamin E, secondaryOutcomes measure: Biochemical analysis: Carotenes, secondaryOutcomes measure: Biochemical analysis: Retinol, secondaryOutcomes measure: Biochemical analysis: Water, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Santiago de Compostela, city: Santiago De Compostela, state: La Coruña, zip: 15782, country: Spain, geoPoint lat: 42.88052, lon: -8.54569, locations facility: University of Navarra, city: Pamplona, state: Navarra, zip: 31009, country: Spain, geoPoint lat: 42.81687, lon: -1.64323, locations facility: Institut Hospital del Mar d'Investigacions Mèdiques, city: Barcelona, zip: 08003, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: University of Cordoba, city: Córdoba, zip: 14071, country: Spain, geoPoint lat: 37.89155, lon: -4.77275, locations facility: Rovira i Virgili University, city: Tarragona, zip: 43002, country: Spain, geoPoint lat: 41.11667, lon: 1.25, locations facility: University of Valencia, city: Valencia, zip: 46010, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, locations facility: University of Zaragoza, city: Zaragoza, zip: 50018, country: Spain, geoPoint lat: 41.65606, lon: -0.87734, hasResults: False