[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631213":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":33,"centralContacts":72,"locations":79,"responsibleParty":198,"collaborators":33,"id":200,"slug":201,"hasResults":202,"nctId":203,"briefTitle":204,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":202,"sex":207,"minAge":208,"maxAge":33,"enrollmentInfo":209,"targetDuration":33,"studyType":212,"phases":213,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":221,"whyStopped":33,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard lifestyle intervention","ACTIVE_COMPARATOR","Personalized dietary and physical activity advices will be provided at baseline (investigator, dietitian, educator for adapted physical activities) and reinforced\u002Fadjusted at on-site visits V1 (investigator and dietitian) and V2 (investigator and dietitian). To standardize on-site lifestyle interventions in all centers and in both arms, health professional training and monitoring will be ensured by a coordinating dietitian and a coordinating educator for adapted physical activities from the project coordinating team.",[13,14,15,16,17,18,19,20],"Other: Fibroscan CAP\u002FVTE","Other: Randomization","Radiation: MRI-PDFF","Behavioral: Diet and physical activity personalized advice","Behavioral: Evaluation of nutritional intakes","Behavioral: Evaluation of nutritional knowledge questionnaire","Behavioral: Evaluation of physical activity level (GPAQ)","Behavioral: Quality of life (EQ 5D 5L)",{"label":22,"type":23,"description":24,"interventionNames":25},"Connected lifestyle intervention","EXPERIMENTAL","Patients will benefit from personalized dietary and physical activity advices in face-to-face meetings at baseline (medical investigator, dietitian and educator for adapted physical activities), 6 months (medical investigator and dietitian) and 12 months (medical investigator and dietitian) associated with a 12-month connected lifestyle intervention program at home: nutritional and physical activity monitoring, weekly artificial intelligence-driven advices and monthly interactions with health professionals through secure messaging.\n\nPatients randomized in the connected intervention group will be given connected tools and will be trained in the use of lifestyle educational\u002Fadvice software applications (available via study-supplied tablet,smartphone or computer).",[13,14,15,16,17,18,19,20,26,27],"Behavioral: Number and time of connections","Behavioral: Satisfaction questionnaire",[29,34,38,43,48,52,56,60,64,68],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Fibroscan CAP\u002FVTE","A FibroScan CAP is a specific ultrasound technology that allows for the assessment of liver stiffness and lipid alterations by measuring:\n\n* Liver elasticity, defined by the speed at which sound waves propagate. This correlates well with the degree of liver fibrosis.\n* The attenuation of ultrasound waves in the liver. This correlates with steatosis.",[22,9],null,{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Randomization","In order to ensure the comparability of both arms (connected versus standard lifestyle intervention) in terms of major confounding factors, the 1:1 randomization procedure is planned to be stratified by centre, gender and history of diabetes.",[22,9],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":33},"RADIATION","MRI-PDFF","Proton density fat fraction magnetic resonance imaging (PDFF MRI) of liver tissue is a non-invasive and quantitative biomarker, derived from magnetic resonance imaging, that allows for the assessment of liver fat content.",[22,9],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":33},"BEHAVIORAL","Diet and physical activity personalized advice","If the participant is randomized in the control group, a final interview with the investigator validates the lifestyle modification advice given.\n\nIf the participant is randomized in the connected intervention group, she\u002Fhe receives training in the use of the telemonitoring device and her\u002Fhis characteristics are entered into the software so that she\u002Fhe can benefit from personalized advice concerning his diet and physical activity.",[22,9],{"type":44,"name":49,"description":50,"armGroupLabels":51,"otherNames":33},"Evaluation of nutritional intakes","This is a survey on patients' food intake (meals, snacks, drinks). For 3 days, they will have to indicate the exact nature of the product consumed, its quantity, the cooking method, the fat used and its quantity, as well as the time and place of consumption.",[22,9],{"type":44,"name":53,"description":54,"armGroupLabels":55,"otherNames":33},"Evaluation of nutritional knowledge questionnaire","This is a questionnaire about knowledge in nutrition and physical activity, consisting of 19 multiple-choice questions",[22,9],{"type":44,"name":57,"description":58,"armGroupLabels":59,"otherNames":33},"Evaluation of physical activity level (GPAQ)","This questionnaire asks about the time the patient spends on different physical activities during the week. It is divided into four sections: \"activities at work,\" \"traveling from one place to another,\" \"leisure activities,\" and \"sedentary behavior.\" The patient must answer a total of 16 questions.",[22,9],{"type":44,"name":61,"description":62,"armGroupLabels":63,"otherNames":33},"Quality of life (EQ 5D 5L)","This is a quality of life questionnaire consisting of 5 questions covering the following areas: mobility, independence, daily activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression. In addition, this questionnaire also includes a scale from 0 (worst imaginable health condition) to 100 (best imaginable health condition) on which the respondent can indicate their health status.",[22,9],{"type":44,"name":65,"description":66,"armGroupLabels":67,"otherNames":33},"Number and time of connections","This document details the connection data that will be collected during the study: - Educational software and S@VE LIVER application: connection dates, duration of use, number of uses\n\n* Sensor: dates and number of uses for each sensor, synchronization dates\n* Technical alerts: date and number of alerts received per patient during monitoring",[22],{"type":44,"name":69,"description":70,"armGroupLabels":71,"otherNames":33},"Satisfaction questionnaire","This is a patient satisfaction questionnaire regarding:\n\n* the training received at the beginning of the protocol\n* the ease of use of the device's components\n* the device's functionality\n* the device's usefulness\n* meal logging\n* the recipe section\n* the connected scale\n* the activity tracker\n* all the software The patient can write comments in each section",[22],[73],{"name":74,"role":75,"phone":76,"phoneExt":77,"email":78},"Pierre GOURDY, MD","CONTACT","5 61 32 37 40","+33","gourdy.p@chu-toulouse.fr",[80,96,109,122,135,148,161,174,188],{"facility":81,"status":33,"city":82,"state":33,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"CHU Angers","Angers","49933","France","FR",{"type":87,"coordinates":88},"Point",[89,90],-0.55202,47.47156,{"lat":90,"lon":89},[93],{"name":94,"role":75,"phone":33,"phoneExt":33,"email":95},"Jérôme BOURSIER, MD","JeBoursier@chu-angers.fr",{"facility":97,"status":33,"city":98,"state":33,"zip":99,"country":84,"countryCode":85,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"APHP Hôpital Beaujon","Clichy","92110",{"type":87,"coordinates":101},[102,103],2.30952,48.90018,{"lat":103,"lon":102},[106],{"name":107,"role":75,"phone":33,"phoneExt":33,"email":108},"Laurent CASTERA, MD","laurent.castera@aphp.fr",{"facility":110,"status":33,"city":111,"state":33,"zip":112,"country":84,"countryCode":85,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"CHU Dijon Hôpital Le Bocage","Dijon","21000",{"type":87,"coordinates":114},[115,116],5.01391,47.31344,{"lat":116,"lon":115},[119],{"name":120,"role":75,"phone":33,"phoneExt":33,"email":121},"Jean-Michel PETIT, MD","jean-michel.petit@chu-dijon.fr",{"facility":123,"status":33,"city":124,"state":33,"zip":125,"country":84,"countryCode":85,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"CHU Lyon","Lyon","69310",{"type":87,"coordinates":127},[128,129],4.84789,45.74906,{"lat":129,"lon":128},[132],{"name":133,"role":75,"phone":33,"phoneExt":33,"email":134},"Cyrielle CAUSSY, MD","cyrielle.caussy@chu-lyon.fr",{"facility":136,"status":33,"city":137,"state":33,"zip":138,"country":84,"countryCode":85,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"CHU Nantes","Nantes","44093",{"type":87,"coordinates":140},[141,142],-1.55336,47.21725,{"lat":142,"lon":141},[145],{"name":146,"role":75,"phone":33,"phoneExt":33,"email":147},"Bertrand CARIOU, MD","bertrand.cariou@univ-nantes.fr",{"facility":149,"status":33,"city":150,"state":33,"zip":151,"country":84,"countryCode":85,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"APHP Cochin","Paris","75014",{"type":87,"coordinates":153},[154,155],2.3488,48.85341,{"lat":155,"lon":154},[158],{"name":159,"role":75,"phone":33,"phoneExt":33,"email":160},"Lucia PARLATI, MD","lucia.parlati@aphp.fr",{"facility":162,"status":33,"city":163,"state":33,"zip":164,"country":84,"countryCode":85,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"CHU Bordeaux","Pessac","33600",{"type":87,"coordinates":166},[167,168],-0.6324,44.80565,{"lat":168,"lon":167},[171],{"name":172,"role":75,"phone":33,"phoneExt":33,"email":173},"Victor DE LEDINGHEN, MD","victor.deledinghen@chu-bordeaux.fr",{"facility":175,"status":33,"city":176,"state":33,"zip":177,"country":84,"countryCode":85,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"CHU Toulouse Rangueil","Toulouse","31059",{"type":87,"coordinates":179},[180,181],1.44367,43.60426,{"lat":181,"lon":180},[184,185],{"name":74,"role":75,"phone":76,"phoneExt":77,"email":78},{"name":186,"role":187,"phone":33,"phoneExt":33,"email":33},"Christophe BUREAU, MD","SUB_INVESTIGATOR",{"facility":189,"status":33,"city":176,"state":33,"zip":190,"country":84,"countryCode":85,"cosmosGeoPoint":191,"geoPoint":193,"contacts":194},"Clinique Pasteur Toulouse","31300",{"type":87,"coordinates":192},[180,181],{"lat":181,"lon":180},[195],{"name":196,"role":75,"phone":33,"phoneExt":33,"email":197},"Maeva GUILLAUME, MD","mguillaume@clinique-pasteur.com",{"type":199,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100631213","impact-of-artificial-intelligence-algorithm-driven-versus-standard-lifestyle-intervention-in-non-alcoholic-fatty-liver-disease---a-multicenter-randomized-open-label-controlled-trial-100631213",false,"NCT07497750","Impact of Artificial Intelligence Algorithm-driven Versus Standard Lifestyle Intervention in Non-Alcoholic Fatty Liver Disease - A Multicenter, Randomized, Open-label, Controlled Trial","S@VE-LIVER","Inclusion criteria:\n\n* Male or female aged 18 years or older;\n* Body mass index (BMI) between 25.0 and 45.0 kg\u002Fm² (including limit values);\n* Stable body weight for at least 3 months prior to inclusion (weight gain or loss \\\u003C 3%);\n* Medical history supporting the diagnosis of Non-alcoholic Fatty Liver Disease diagnosis (including available biology, imaging and\u002For histology data from the medical file);\n* Presence of significant liver steatosis attested by Fibroscan® Controlled Attenuation Parameter (CAP) value \\> 300 dB\u002Fm;\n* Absence of severe fibrosis attested by Fibroscan Vibration controlled Transient Elastography (VTE) value \\\u003C 8.5 kPa (corresponding to stage F0-F2);\n* Availability of a WIFI internet connection at patient home\n* Able to provide written informed consent and agree to comply with the study protocol;\n* Covered by a French National Health Insurance plan\n\nExclusion criteria:\n\n* History of liver disease other than NAFLD;\n* History of cirrhosis and\u002For liver cancer;\n* History of alcohol abuse and\u002For significant consumption in the past six months;\n* AST or ALT \\> 5 times the upper limit of normal;\n* History of diabetes mellitus with another etiological diagnosis than type 2 diabetes;\n* Type 2 diabetes with HbA1c ≥ 8% and\u002For requiring insulin therapy;\n* Type 2 diabetes with significant change in oral antidiabetic therapy in the last 3 months;\n* Type 2 diabetes with significant change in GLP-1RA therapy in the last 6 months;\n* History of bariatric surgery or bariatric surgery planned during the study period;\n* Use of medications affecting weight or energy intake\u002Fexpenditure in the last 3 months, including weight loss medications, corticosteroids, antipsychotic drugs or other medications according to investigator's opinion;\n* History of hypothyroidism with abnormal TSH value and\u002For adjustment of hormonal therapy in the last 3 months;\n* Severe chronic renal failure (eGFR\\\u003C30 ml\u002Fmin\u002F1.73 m2);\n* Severe cardiovascular disease, heart failure or any other medical condition not compatible with participation in the study according to investigator's opinion;\n* History of malignant tumor, unless considered to be in remission for 5 years or more;\n* Pregnant women or women planning to become pregnant;\n* Contra-indication to MRI examination or condition not allowing MRI to be carried out;\n* Persons participating in another research including a period of exclusion still in course\n* Patients who are unwilling or unable to give informed consent\n* Persons placed under judicial protection","ALL","18 Years",{"count":210,"type":211},216,"ESTIMATED","INTERVENTIONAL",[214],"NA","Now considered as a major public health challenge, non-alcoholic fatty liver disease (NAFLD) is rapidly rising as a major cause of end-stage liver disease. NAFLD encompasses a spectrum of conditions, ranging from steatosis, defined by excessive liver fat deposition, to Non-Alcoholic Steato-Hepatitis (NASH), an inflammatory and fibrotic stage which promotes severe complications such as cirrhosis and hepatocellular carcinoma.\n\nAlthough several drugs are currently under clinical development to limit inflammation and fibrosis processes, clinical evidence and previous studies support the role of lifestyle intervention (dietary modifications and exercise) as a cornerstone for NAFLD management. Indeed, insulin resistance is a key pathogenic trigger of the disease and patients with NAFLD are frequently obese and\u002For have type 2 diabetes. Therefore, lifestyle intervention should be implemented as early as possible in the disease course, from the first evidence of steatosis.\n\nDesigning lifestyle interventions with good efficacy and sustainability for patients with NAFLD, and with acceptable medico-economic costs, is thus urgently needed. However, the optimal way to implement such lifestyle modification programs remains unclear. Technological innovations in health-monitoring devices recently made it possible to propose disruptive lifestyle interventions, but the value of such strategies has not been addressed in NAFLD so far.",[217],"Non Alcoholic Fatty Liver Disease",[219,220],"artificial intelligence","Non-Alcoholic Fatty Liver Disease","NOT_YET_RECRUITING","2026-03-23",{"date":224,"type":225},"2026-03-27","ACTUAL",{"date":227,"type":211},"2026-06-01",{"date":229,"type":211},"2030-12-31",{"name":5,"class":6},9]