Impact of Artificial Intelligence Algorithm-driven Versus Standard Lifestyle Intervention in Non-Alcoholic Fatty Liver Disease - A Multicenter, Randomized, Open-label, Controlled Trial

Prior treatment

• Use of medications affecting weight or energy intake/expenditure in the last 3 months, including weight loss medications, corticosteroids, antipsychotic drugs or other medications according to investigator's opinion;

Other illness

• History of liver disease other than NAFLD;
• History of cirrhosis and/or liver cancer;
• History of alcohol abuse and/or significant consumption in the past six months;
• History of diabetes mellitus with another etiological diagnosis than type 2 diabetes;
• Type 2 diabetes with significant change in oral antidiabetic therapy in the last 3 months;
• Type 2 diabetes with significant change in GLP-1RA therapy in the last 6 months;
• History of bariatric surgery or bariatric surgery planned during the study period;
• History of hypothyroidism with abnormal TSH value and/or adjustment of hormonal therapy in the last 3 months;
• Severe cardiovascular disease, heart failure or any other medical condition not compatible with participation in the study according to investigator's opinion;
• History of malignant tumor, unless considered to be in remission for 5 years or more;
• Contra-indication to MRI examination or condition not allowing MRI to be carried out;

Lab values

• AST or ALT \> 5 times the upper limit of normal;
• Type 2 diabetes with HbA1c ≥ 8% and/or requiring insulin therapy;
• Severe chronic renal failure (eGFR\<30 ml/min/1.73 m2);

Other

• Pregnant women or women planning to become pregnant;
• Persons participating in another research including a period of exclusion still in course
• Patients who are unwilling or unable to give informed consent
• Persons placed under judicial protection

• Male or female aged 18 years or older;
• Body mass index (BMI) between 25.0 and 45.0 kg/m² (including limit values);
• Stable body weight for at least 3 months prior to inclusion (weight gain or loss \< 3%);
• Medical history supporting the diagnosis of Non-alcoholic Fatty Liver Disease diagnosis (including available biology, imaging and/or histology data from the medical file);
• Presence of significant liver steatosis attested by Fibroscan® Controlled Attenuation Parameter (CAP) value \> 300 dB/m;
• Absence of severe fibrosis attested by Fibroscan Vibration controlled Transient Elastography (VTE) value \< 8.5 kPa (corresponding to stage F0-F2);
• Availability of a WIFI internet connection at patient home
• Able to provide written informed consent and agree to comply with the study protocol;
• Covered by a French National Health Insurance plan