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

Summary

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.

Conditions

• MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
• MASLD
• Cardiovascular Events

Interventions

BEHAVIORAL

Hepatologic-provided recommendations

Hepatologic counseling will be offered every six months to individuals belonging to all study groups. These specialists-provided check-ups consisted of recording, at baseline, demographics and, at baseline and every six months, collecting anthropometrical, biochemical, clinical (including the assessment of previous cardiovascular events and the determination of individual cardiovascular risk), and body composition data, as well as evaluating the liver disease progression by using Noninvasive tools (NITs) (Fibroscan CAP). Moreover, at baseline, the hepatologist, after assessing the initial compliance of each individual with the Mediterranean diet and active physical exercise, by respectively adopting the MDS questionnaire and the IPAQ-SF score questionnaire, also recommended, for the entire duration of the study, generic lifestyle changes, including a Mediterranean diet style, and proper physical activity (\> 150 min/week of moderate - or 75 min/week of vigorous physical activity).

BEHAVIORAL

Nutritional support

Nutritional counseling by a specialist will be provided on a semestral basis, scheduled on the same day as the hepatology follow-up visits, although conducted separately and after the hepatology consultation, and was offered exclusively to patients in Groups B and C. In these occasions, specialised anamnesis will be performed (including the investigation of general dietary habits, food allergies, and taste preferences), as well as the multicompartmental BIA-assessed body composition results will be properly interpreted to design, and eventually dynamically change along the duration of the study, a personalised dietary plan with a tailored physical activity strategy (integrating the generic recommendations received by the hepatologists), as well as to establish, and periodically revaluate, individual body composition outcomes.

BEHAVIORAL

Psychological support

The psychological intervention will be structured in sequential phases to enhance disease awareness, coping skills, and adherence to lifestyle changes. The first 90-minute session will include a comprehensive personal, familial, and physiological assessment, with systematic evaluation of social determinants of health using a dedicated CRF. The psychologist will assess disease awareness, quality of life, motivation for change, and treatment expectations. Emotional and cognitive components will be explored through interviews and standardized tools (BAI, BDI-II). Individualized therapeutic goals will be jointly defined. Weekly 60-minute sessions over six months will address previous behavioural change attempts, barriers, facilitators, and strategy refinement. Motivation will be continuously monitored according to the Transtheoretical Model. Semiannual follow-up sessions will reassess progress and address emotional or situational challenges.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-01

Primary Completion

2025-12-01

Completion

2025-12-20

Countries

• Italy

Study Locations