Integrating Hepatological, Nutritional, and Psychological Support as a Multidisciplinary Management to Improve Long-term Clinical Outcomes in MASLD

Metabolic dysfunction associated Steatotic Liver Disease (MASLD) is frequently complicated by cardiometabolic (CMR) comorbidities, and prognosis is substantially influenced by acute cardiovascular events (ACE). Although several pharmacological approaches target CMR risk factors, lifestyle modification remains the cornerstone of management. However, adherence to dietary behavioral prescriptions is often poor, and the influence of sociodemographic determinants on compliance remains unclear. Moreover, the long-term real-life impact of behavioral and motivational support in MASLD is insufficiently characterized. This randomized controlled trial aims to evaluate the effectiveness of a multidisciplinary management (including Hepatological counseling, Nutrition intervention, and Psychological support) in improving clinical MASLD outcomes, by increasing adherence to specialist-tailored recommendations.

NCT Number	NCT07366463
Lead Sponsor	University of Campania Luigi Vanvitelli
Conditions	MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD, Cardiovascular Events
Enrollment	286 participants
Start Date	2023-07-01
Primary Completion	2025-12-01 (estimated)
Study Completion	2025-12-20 (estimated)
Updated on ClinicalTrials.gov	2026-02-12