About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Fibroscan CAP/VTE
- Randomization
- MRI-PDFF
- Diet and physical activity personalized advice
- Evaluation of nutritional intakes
- Evaluation of nutritional knowledge questionnaire
- Evaluation of physical activity level (GPAQ)
- Quality of life (EQ 5D 5L)
- Number and time of connections
- Satisfaction questionnaire