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

University of Campania Luigi Vanvitelli

Status: Completed

Conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; Cardiovascular Events; MASLD

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07366463

0016368/i

Details and patient eligibility

About

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.

Full description

Metabolic dysfunction-associated Steatotic Liver disease (MASLD) represents a predominant hepatopathy worldwide, as well as a complex systemic condition complicated by various extra-hepatic dysmetabolic manifestations.

Among these, acute cardiovascular events represent a serious burden, drastically increasing mortality rates, emphasizing the absolute need for holistic and multidisciplinary treatment strategies.

Even though several pharmacological approaches have been proposed, targeting the different dysmetabolic manifestations, lifestyle changes remain the paramount intervention for patients with simple steatosis. However, adherence to dietary and behavioral recommendations is often poor. Growing evidence highlights the importance of cognitive behavioral therapy (CBT) in supporting these recommendations. However, the real benefits of providing motivational support to individuals with MASLD remain largely unexplored in real-world applications.

This randomized controlled trial aims to evaluate the effectiveness of a multidisciplinary approach (integrating Hepatological counseling, Nutrition intervention, and Psychological support) in improving long-term clinical MASLD outcomes, by increasing adherence to specialist-tailored recommendations, as well as to investigate the social determinants impacting on the loss of compliance with this strategy.

MASLD patients will be consecutively enrolled and randomized into three Groups:

• Group A - following generic hepatologist-provided advice ("H"),
• Group B- also receiving a nutritionist-prescribed individualized intervention ("HN")
• Group C- receiving an approach which additionally involves cognitive/behavioral-based psychological support ("HNP")

Groups A and B represent the "standard of care" cohort, while Group B represents the "experimental" cohort.

Baseline anthropometric, biochemical, clinical, liver stiffness (LSM), controlled attenuation parameter (CAP), lifestyle habits (including dietary and physical exercise), and body composition values will be recorded.

Along 18 months:

• Semestral hepatological (for all), nutritional (H and HN), and psychological (HNP) follow-ups reassess variables and evaluated compliance.
• Acute Cardiovascular events will be recorded

Enrollment: 286 patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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286 participants in 3 patient groups

Group A - "Hep"

Active Comparator group

Description:

Hepatologist counseling providing generic lifestyle recommendations

Treatment:

Behavioral: Hepatologic-provided recommendations

Group B - "Hep + Nut"

Active Comparator group

Description:

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

Treatment:

Behavioral: Hepatologic-provided recommendations

Behavioral: Nutritional support

Group C - "Hep + Nut + Psy"

Experimental group

Description:

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

Treatment:

Behavioral: Hepatologic-provided recommendations

Behavioral: Psychological support

Behavioral: Nutritional support