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)

Toulouse University Hospital

Status: Begins enrollment this month

Conditions: Non Alcoholic Fatty Liver Disease

Treatments: Behavioral: Quality of life (EQ 5D 5L); Behavioral: Evaluation of nutritional knowledge questionnaire; Behavioral: Evaluation of physical activity level (GPAQ); Behavioral: Satisfaction questionnaire; Behavioral: Number and time of connections; Behavioral: Diet and physical activity personalized advice; Behavioral: Evaluation of nutritional intakes; Other: Randomization; Radiation: MRI-PDFF; Other: Fibroscan CAP/VTE

Study type: Interventional

Funder types: Other

Identifiers

NCT07497750

RC31/21/0335

2023-A02422-43 (Other Identifier)

Details and patient eligibility

About

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.

Although 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/or have type 2 diabetes. Therefore, lifestyle intervention should be implemented as early as possible in the disease course, from the first evidence of steatosis.

Designing 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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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;
• AST or ALT > 5 times the upper limit of normal;
• History of diabetes mellitus with another etiological diagnosis than type 2 diabetes;
• Type 2 diabetes with HbA1c ≥ 8% and/or requiring insulin therapy;
• 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;
• 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;
• History of hypothyroidism with abnormal TSH value and/or adjustment of hormonal therapy in the last 3 months;
• Severe chronic renal failure (eGFR<30 ml/min/1.73 m2);
• 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;
• Pregnant women or women planning to become pregnant;
• Contra-indication to MRI examination or condition not allowing MRI to be carried out;
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Standard lifestyle intervention

Active Comparator group

Description:

Personalized dietary and physical activity advices will be provided at baseline (investigator, dietitian, educator for adapted physical activities) and reinforced/adjusted 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.

Treatment:

Radiation: MRI-PDFF

Other: Fibroscan CAP/VTE

Behavioral: Evaluation of nutritional intakes

Other: Randomization

Behavioral: Diet and physical activity personalized advice

Behavioral: Quality of life (EQ 5D 5L)

Behavioral: Evaluation of physical activity level (GPAQ)

Behavioral: Evaluation of nutritional knowledge questionnaire

Connected lifestyle intervention

Experimental group

Description:

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. Patients randomized in the connected intervention group will be given connected tools and will be trained in the use of lifestyle educational/advice software applications (available via study-supplied tablet,smartphone or computer).

Treatment:

Radiation: MRI-PDFF

Other: Fibroscan CAP/VTE

Behavioral: Evaluation of nutritional intakes

Other: Randomization

Behavioral: Diet and physical activity personalized advice

Behavioral: Number and time of connections

Behavioral: Satisfaction questionnaire

Behavioral: Quality of life (EQ 5D 5L)

Behavioral: Evaluation of physical activity level (GPAQ)

Behavioral: Evaluation of nutritional knowledge questionnaire