NCT07366463

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

Integrating Hepatological, Nutritional, and Cognitive Behavioral Therapy-based Psychological Support is an Effective Multidisciplinary Approach to Improve Long-term Clinical Outcomes in the Management of MASLD Patients: a Randomized Clinical Trial [The "CoCoNut" Study]

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 40 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-12-01
• Completion: 2025-12-20
• First posted: 2026-01-26
• Last updated: 2026-02-12

Locations

1 site across 1 country: Italy