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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02422-43 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard lifestyle intervention | Active Comparator | 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. |
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| Connected lifestyle intervention | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibroscan CAP/VTE | Other | A FibroScan CAP is a specific ultrasound technology that allows for the assessment of liver stiffness and lipid alterations by measuring:
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of fat content | Percentage of liver fat content measured by PDF MRI | 12 months |
| Determination of fat content | Liver fat percentage measured by Fibroscan CAP |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre GOURDY, MD | Contact | 5 61 32 37 40 | +33 | gourdy.p@chu-toulouse.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | 49933 | France |
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Controlled trial in parallel groups: home connected device including artificial intelligence algorithms versus standard lifestyle intervention
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| Randomization | Other | 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. |
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| MRI-PDFF | Radiation | 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. |
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| Diet and physical activity personalized advice | Behavioral | 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. |
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| Evaluation of nutritional intakes | Behavioral | 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. |
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| Evaluation of nutritional knowledge questionnaire | Behavioral | This is a questionnaire about knowledge in nutrition and physical activity, consisting of 19 multiple-choice questions |
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| 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. |
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| 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. |
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| Number and time of connections | Behavioral | 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
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| Satisfaction questionnaire | Behavioral | This is a patient satisfaction questionnaire regarding:
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| 24 months |
| Determination of the fibrosis score | Percentage of fibrosis score measured by Fibroscan® Vibration-controlled Transient Elastography (VTE) | 24 months |
| APHP Hôpital Beaujon | Clichy | 92110 | France |
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| CHU Dijon Hôpital Le Bocage | Dijon | 21000 | France |
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| CHU Lyon | Lyon | 69310 | France |
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| CHU Nantes | Nantes | 44093 | France |
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| APHP Cochin | Paris | 75014 | France |
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| CHU Bordeaux | Pessac | 33600 | France |
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| CHU Toulouse Rangueil | Toulouse | 31059 | France |
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| Clinique Pasteur Toulouse | Toulouse | 31300 | France |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D011897 | Random Allocation |
| D004032 | Diet |
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
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