NCT07497750

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
OTHER	Fibroscan CAP/VTE	A FibroScan CAP is a specific ultrasound technology that allows for the assessment of liver stiffness and lipid alterations by measuring: * Liver elasticity, defined by the speed at which sound waves propagate. This correlates well with the degree of liver fibrosis. * The attenuation of ultrasound waves in the liver. This correlates with steatosis.
OTHER	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.
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.
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. If the participant is randomized in the connected intervention group, she/he receives training in the use of the telemonitoring device and her/his characteristics are entered into the software so that she/he can benefit from personalized advice concerning his diet and physical activity.
BEHAVIORAL	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.
BEHAVIORAL	Evaluation of nutritional knowledge questionnaire	This is a questionnaire about knowledge in nutrition and physical activity, consisting of 19 multiple-choice questions
BEHAVIORAL	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.
BEHAVIORAL	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/discomfort, and anxiety/depression. 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.
BEHAVIORAL	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 * Sensor: dates and number of uses for each sensor, synchronization dates * Technical alerts: date and number of alerts received per patient during monitoring
BEHAVIORAL	Satisfaction questionnaire	This is a patient satisfaction questionnaire regarding: * the training received at the beginning of the protocol * the ease of use of the device's components * the device's functionality * the device's usefulness * meal logging * the recipe section * the connected scale * the activity tracker * all the software The patient can write comments in each section

Timeline

• Start date: 2026-06-01
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

9 sites across 1 country: France