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

NCT07366463 | Completed DMC

• 1 other identifier: 0016368/i
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Multidisciplinary; Nutrition; Cognitive behavioral therapy; Personalized medicine

Outcome Measures

Primary Outcomes (1)

• Body Weight reduction

  The primary endpoint of this study was to highlight a significantly higher proportion (at least \> 15%) of patients obtaining (intermediate time-point, i.e., after 12 months), and maintaining (end of the study, i.e., after 18 months), a reduction of at least 10% in body weight in the experimental cohort compared with the standard of care

  From enrollment to the end of intervention at 18 months

Secondary Outcomes (7)

• Variations in anthropometric parameters

  From enrollment to the end of intervention at 18 months

• Different risk of acute cardiovascular events

  From enrollment to the end of intervention at 18 months

• Variations in metabolic variables (glycometabolic)

  From enrollment to the end of intervention at 18 months

• Variations in metabolic parameters (lipidic variables)

  From enrollment to the end of intervention at 18 months

• Variations in body composition

  From enrollment to the end of intervention at 18 months

Other Outcomes (1)

• Relationship between anxiety severity and levels of compliance with the intervention

  From enrollment to the end of intervention at 18 months

Study Arms (3)

Group A - "Hep"

ACTIVE COMPARATOR

Hepatologist counseling providing generic lifestyle recommendations

Behavioral: Hepatologic-provided recommendations

Group B - "Hep + Nut"

ACTIVE COMPARATOR

Hepatologist counseling with the integration of tailored lifestyle recommendations, including personalized physical exercise and dietary plan, provided by a nutritionist

Behavioral: Hepatologic-provided recommendations; Behavioral: Nutritional support

Group C - "Hep + Nut + Psy"

EXPERIMENTAL

Hepatologist counseling with the integration of tailored lifestyle recommendations, including personalized physical exercise and dietary plan, provided by a nutritionist, combined with cognitive behavioral therapy (CBT) program-based psychological support, offered by a psychologist specialist

Behavioral: Hepatologic-provided recommendations; Behavioral: Nutritional support; Behavioral: Psychological support

Interventions

Hepatologic-provided recommendations BEHAVIORAL

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).

Group A - "Hep"; Group B - "Hep + Nut"; Group C - "Hep + Nut + Psy"

Nutritional support BEHAVIORAL

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.

Group B - "Hep + Nut"; Group C - "Hep + Nut + Psy"

Psychological support BEHAVIORAL

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.

Also known as: Cognitive behavioral therapy

Group C - "Hep + Nut + Psy"

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 40 and 79 years,
• a diagnosis of MASLD, configured by the presence of hepatic steatosis (proven by instrumental and/or histological methods), with at least one of the five cardiometabolic risk factors (CMRFs) as established by the updated multi-society Delphi consensus proposed criteria,
• willingness to sign a valid informed consent

You may not qualify if:

• unavailability or inability to express written consent,
• chronic liver diseases other than MASLD/overlap ongoing causes (including chronic hepatitis B virus infection, chronic hepatitis C virus infection, autoimmune hepatitis, chronic cholestasis, genetic diseases determining steatosis, and alcohol-related liver disorder assumed in the evidence of a history of alcohol intake greater than 20 g/day or 140 g/week),
• administration of liver-damaging (Drug-induced liver Injury) (DILI) / hepatic steatosis inducing drugs (Drug-Induced Fatty Liver Disease) (DIFLD),
• hepatoprotective drugs administration,
• consumption of hypoglycemic, hypolipidemic, and weight loss agents, as well as any drug known to influence liver function,
• neoplasms,
• chronic systemic inflammatory diseases,
• eating disorders (ED)
• other psychiatric disorders potentially invalidating the consent.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania Luigi Vanvitelli

Naples, Campania, 80138, Italy

Location

Related Publications (2)

• Romeo M, Dallio M, Cipullo M, Coppola A, Mazzarella C, Mammone S, Iadanza G, Napolitano C, Vaia P, Ventriglia L, Federico A. Nutritional and Psychological Support as a Multidisciplinary Coordinated Approach in the Management of Chronic Liver Disease: A Scoping Review. Nutr Rev. 2025 Jul 1;83(7):1327-1343. doi: 10.1093/nutrit/nuaf001.

  PMID: 39992295 BACKGROUND

• M. Romeo, M. Dallio, F. Di Nardo, A. Coppola, P. Vaia, C. Napolitano, G. Martinelli, S. Olivieri, M. Niosi, A. Federico, Multidisciplinary management combining hepatologist counseling, cognitive/behavioral therapy, and nutritional support significantly improves clinical outcomes of Metabolic dysfunction-associated Steatotic Liver Disease (MASLD) patients, Digestive and Liver Disease, Volume 56, Supplement 3, 2024, Pages S318-S319, ISSN 1590-8658, https://doi.org/10.1016/j.dld.2024.08.009. (https://www.sciencedirect.com/science/article/pii/S1590865824009289)

  RESULT

MeSH Terms

Interventions

Nutritional Support; Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: To conceal the allocation of the patients, block sizes will not be disclosed to investigators enrolling patients, and investigators recruiting patients will not know to which group the next patient will be assigned. For this purpose, investigators not involved in patient enrollment (i.e., external investigators) will prepare a sequence of numbered, opaque, sealed envelopes containing the patient's group. To prevent tampering, the list will remain inaccessible, and the envelopes will be opened sequentially after enrolling the patient and obtaining consent.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: In this randomized controlled trial (RCT), patients admitted to the Hepatogastroenterology Unit of the "Luigi Vanvitelli" University Hospital presenting with a diagnosis of MASLD will consecutively enrolled and randomized to receive hepatologist counseling with generic lifestyle recommendations (Group A - "Hep"), hepatologist counseling with the integration of tailored lifestyle recommendations, including personalized physical exercise and dietary plan, provided by a nutritionist (Group B - "Hep + Nut"), or hepatologist counseling with the integration of tailored lifestyle recommendations, including personalized physical exercise and dietary plan, provided by a nutritionist, combined with CBT program-based psychological support, offered by a psychologist specialist, for a period of 18 months (Group C - "Hep + Nut + Psy"). . Groups A and B constituted the standard of care, while Group C, receiving the multidisciplinary triple approach ("Co-Co-Nut" ), represented the experimental.

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 26, 2026
• Study Start: July 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 20, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)