[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502027":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":37,"responsibleParty":57,"collaborators":18,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":18,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":18,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"General University Hospital, Prague","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Professional lifestyle modification counselling (behavioral therapy)","EXPERIMENTAL","Lifestyle intervention will be based on CBT (cognitive behavioral therapy) and mindfulness, especially mindful eating by professional organisation STOB.",[13],"Behavioral: Cognitive behavioral therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"standard care","NO_INTERVENTION","Patients will have standard care with regular visits at an outpatient Department of Hepatology. Standard recommendations of lifestyle change and weight reduction will be given by hepatologists.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Cognitive behavioral therapy","Subjects will receive professional lifestyle intervention conducted by STOB organization. Using CBT and the so-called third wave of CBT, especially mindfulness, the patients will be guided by certified experts to increase motivation and to change eating and exercise habits, which will be mapped before and after the intervention.",[9],[26],{"name":27,"affiliation":5,"role":28},"Radan Bruha, Prof.","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","+420224962506","bruha@cesnet.cz",{"name":35,"role":31,"phone":32,"phoneExt":18,"email":36},"Vaclav Smid, MD","vaclav.smid@vfn.cz",[38],{"facility":39,"status":40,"city":41,"state":18,"zip":42,"country":43,"countryCode":18,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"General University Hospital","RECRUITING","Prague","12808","Czechia",{"type":45,"coordinates":46},"Point",[47,48],14.42076,50.08804,{"lat":48,"lon":47},[51,53],{"name":27,"role":31,"phone":52,"phoneExt":18,"email":33},"00420224962506",{"name":54,"role":31,"phone":55,"phoneExt":18,"email":56},"Vaclav Smid, Dr.","00420224962467","vaclav.smid.@vfn.cz",{"type":28,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Radan Bruha","Head of 4th Internal clinic","100502027","lifestyle-modification-in-the-treatment-of-nafld-100502027",false,"NCT05816915","Lifestyle Modification in the Treatment of NAFLD.","Complex Lifestyle Modification in the Treatment of Non-alcoholic Fatty Liver Disease","Inclusion Criteria:\n\n* Individuals with NAFLD and metabolic syndrome\n\nExclusion Criteria:\n\n* Etiology of liver disease other than NAFLD.\n* Presence of malignant disease.\n* Uncontrolled cardiovascular disease\n* Pregnancy.","ALL","18 Years",{"count":70,"type":71},100,"ESTIMATED","INTERVENTIONAL",[74],"NA","The project will study the impact of individually tailored lifestyle counselling compared to standard care on the parameters of NAFLD\u002FNASH in patients with metabolic syndrome. The factors affecting the outcome (including clinical and laboratory parameters and microbiome profiling) will be evaluated.",[77],"NAFLD",[77,22],"2024-09-23",{"date":81,"type":82},"2024-09-25","ACTUAL",{"date":84,"type":82},"2023-08-30",{"date":86,"type":71},"2026-12",{"name":5,"class":6},1]