protocolSection identificationModule nctId: NCT06312280, orgStudyIdInfo id: CE342/2023, briefTitle: Evaluation of Body Composition in Pediatric Patients With Overweight or Obesity, acronym: OBIASITY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero Universitaria Maggiore della Carita, class: OTHER, descriptionModule briefSummary: In recent decades, the prevalence of obesity and overweight has dramatically increased globally, representing a serious problem for society and for the health system of many countries, estimating an impact of 2-8% on global health spending. Obesity and overweight represent a problem not only for adults but also for children and adolescents: the latest data from the WHO estimate that about 340 million children and adolescents between 5 and 19 years are overweight or obese, data that increase drastically since 1975 from 4% of boys to 18% in 2016. (World Health Organization (WHO). The reduction and prevention of overweight and obesity in childhood is one of the main missions of public health at the global level, both for short-term and long-term implications. Recently, the importance of bioprothesiometric analysis (BIA) in the clinical routine has been evaluated, as it allows an estimation of body composition that would not otherwise be provided by the growth curves and the calculation of the Body Mass Index (BMI). In this study the investigators want to evaluate, in addition to the classic clinical parameters, the body composition of patients evaluated by means of an impedance balance (named TANITA MC780 MA P). With this study the investigators aim to investigate possible clinical and body composition changes in children and adolescents suffering from overweight and obesity with the ultimate aim of reducing cardio-metabolic risk factors related to it.The objective of the study is the assessment of body composition, as an indicator of accuracy of lean mass, but especially of fat mass, of pediatric patients who are overweight and obesity in order to carry out a more complete evaluation of the clinical-metabolic condition for the prevention of cardiovascular risk.The secondary objective is to assess the dietary compliance of the patients being studied and the possible correlation with the body composition., conditionsModule conditions: Pediatric Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Mediterranean diet, outcomesModule primaryOutcomes measure: Change in Body composition, secondaryOutcomes measure: Dietary compliance with questionnaires, secondaryOutcomes measure: Correlation between change in body composition (primary outcome) and dietary compliance (secondary outcome), eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: SCDU Pediatria, AOU Maggiore della Carità, city: Novara, zip: 28100, country: Italy, contacts name: Simonetta Bellone, MD, role: CONTACT, phone: +39-0321-660693, email: simonetta.bellone@med.uniupo.it, geoPoint lat: 45.44694, lon: 8.62118, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-10-23, uploadDate: 2024-03-13T05:14, filename: Prot_SAP_000.pdf, size: 348071, hasResults: False