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

N/ANot Yet RecruitingNCT07497750

University Hospital, Toulouse216 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

216

Conditions

Non Alcoholic Fatty Liver Disease

Interventions

Fibroscan CAP/VTEOTHER

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.

RandomizationOTHER

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.

MRI-PDFFRADIATION

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.

Diet and physical activity personalized adviceBEHAVIORAL

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.

Evaluation of nutritional intakesBEHAVIORAL

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.

Evaluation of nutritional knowledge questionnaireBEHAVIORAL

This is a questionnaire about knowledge in nutrition and physical activity, consisting of 19 multiple-choice questions

Evaluation of physical activity level (GPAQ)BEHAVIORAL

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.

Quality of life (EQ 5D 5L)BEHAVIORAL

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.

Number and time of connectionsBEHAVIORAL

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

Satisfaction questionnaireBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

CHU Angers

Angers, France

APHP Hôpital Beaujon

Clichy, France

CHU Dijon Hôpital Le Bocage

Dijon, France

CHU Lyon

Lyon, France

CHU Nantes

Nantes, France

APHP Cochin

Paris, France

CHU Bordeaux

Pessac, France

CHU Toulouse Rangueil

Toulouse, France

Clinique Pasteur Toulouse

Toulouse, France

Outcomes

Primary Outcomes

Proportion of participants with a relative decline of at least 30% in liver fat

Percentage of participants with a relative decline of at least 30% in liver fat content measured by MRI-PDFF (Proton Density Fat Fraction) from baseline to 12 months, i.e. at the end of the intervention period.

Time frame: 12 months

Secondary Outcomes

Determination of fat content

Percentage of liver fat content measured by PDF MRI