Clinical nutrition (Edinburgh, Scotland) · 2026
A multidisciplinary nutritional-behavioral intervention improves weight loss and liver-related outcomes in patients with metabolic dysfunction-associated steatotic liver disease: A randomized controlled trial.
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Dallio Marcello, Romeo Mario, Di Nardo Fiammetta, Napolitano Carmine, Coppola Annachiara, Mazzarella Chiara, Vaia Paolo, Basile Claudio, Federico Alessandro
Аннотация
BACKGROUND & AIMS: Metabolic dysfunction-associated steatotic liver disease (MASLD) is strongly associated with cardiometabolic comorbidities and increased cardiovascular risk. Despite emerging pharmacological therapies, lifestyle modification remains the cornerstone of management. However, long-term adherence to dietary and behavioral recommendations remains poor. This study evaluated the benefits of a multidisciplinary intervention integrating hepatological, nutritional, and cognitive behavioral therapy (CBT)-based support ("Co-Co-Nut") on MASLD outcomes and investigated the social determinants of health (SDOH) influencing adherence.
METHODS: A total of 286 consecutively enrolled MASLD patients were initially randomized 1:1 to either the standard-of-care cohort or the experimental cohort. Patients assigned to standard care subsequently underwent a secondary 1:1 allocation into two subgroups: hepatologist-delivered generic lifestyle counselling (A, n = 72) or hepatologist plus individualized nutritional intervention (B, n = 71), whereas the experimental cohort received the full multidisciplinary intervention, including CBT-based behavioral support (C, n = 143). Anthropometric, metabolic, lifestyle, body composition, liver stiffness measurement (LSM), and controlled attenuation parameter (CAP) data were assessed at baseline and at 6, 12, and 18 months. Adherence, SDOH, and incident acute cardiovascular events (ACEs) were also recorded.
RESULTS: The "Co-Co-Nut" intervention significantly increased the proportion of patients achieving ≥10% weight loss and induced sustained improvements in body composition, metabolic profile, LSM, and CAP, which were not observed with standard care (all p < 0.0001). Loss of adherence was significantly lower in the experimental group (p < 0.0001), which also showed a significantly lower risk of ACEs (HR 0.36, 95% CI 0.18-0.71). Adherence at 12 months independently predicted ACE risk reduction (HR 0.27). Large family size (OR 1.87), limited time for meals (OR 1.91), and full-time employment (OR 1.61) (all p < 0.0001) emerged as the SDOH most strongly associated with loss of adherence.
CONCLUSION: A high-intensity multidisciplinary behavioral care model integrating hepatological, nutritional, and CBT-based behavioral support significantly improved medium-term adherence, body composition, metabolic control, and clinically relevant outcomes in MASLD. The present Clinical trial registration NCT07366463 (ClinicalTrials.gov).
CLINICAL TRIAL REGISTRATION: NCT07366463 (ClinicalTrials.gov).
METHODS: A total of 286 consecutively enrolled MASLD patients were initially randomized 1:1 to either the standard-of-care cohort or the experimental cohort. Patients assigned to standard care subsequently underwent a secondary 1:1 allocation into two subgroups: hepatologist-delivered generic lifestyle counselling (A, n = 72) or hepatologist plus individualized nutritional intervention (B, n = 71), whereas the experimental cohort received the full multidisciplinary intervention, including CBT-based behavioral support (C, n = 143). Anthropometric, metabolic, lifestyle, body composition, liver stiffness measurement (LSM), and controlled attenuation parameter (CAP) data were assessed at baseline and at 6, 12, and 18 months. Adherence, SDOH, and incident acute cardiovascular events (ACEs) were also recorded.
RESULTS: The "Co-Co-Nut" intervention significantly increased the proportion of patients achieving ≥10% weight loss and induced sustained improvements in body composition, metabolic profile, LSM, and CAP, which were not observed with standard care (all p < 0.0001). Loss of adherence was significantly lower in the experimental group (p < 0.0001), which also showed a significantly lower risk of ACEs (HR 0.36, 95% CI 0.18-0.71). Adherence at 12 months independently predicted ACE risk reduction (HR 0.27). Large family size (OR 1.87), limited time for meals (OR 1.91), and full-time employment (OR 1.61) (all p < 0.0001) emerged as the SDOH most strongly associated with loss of adherence.
CONCLUSION: A high-intensity multidisciplinary behavioral care model integrating hepatological, nutritional, and CBT-based behavioral support significantly improved medium-term adherence, body composition, metabolic control, and clinically relevant outcomes in MASLD. The present Clinical trial registration NCT07366463 (ClinicalTrials.gov).
CLINICAL TRIAL REGISTRATION: NCT07366463 (ClinicalTrials.gov).