Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

216

participants targeted

Target at P75+ for not_applicable

Timeline

56mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach

1 country

9 active sites

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.6 years study duration

First Submitted

Initial submission to the registry

March 23, 2026

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed

2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4.6 years

First QC Date

March 23, 2026

Last Update Submit

March 23, 2026

Conditions

Non Alcoholic Fatty Liver Disease

Keywords

artificial intelligenceNon-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

Determination of fat content
12 months
Determination of fat content
24 months
Determination of the fibrosis score
24 months

Study Arms (2)

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.

Other: Fibroscan CAP/VTEOther: RandomizationRadiation: MRI-PDFFBehavioral: Diet and physical activity personalized adviceBehavioral: Evaluation of nutritional intakesBehavioral: Evaluation of nutritional knowledge questionnaireBehavioral: Evaluation of physical activity level (GPAQ)Behavioral: Quality of life (EQ 5D 5L)

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).

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.