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]
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 286
- Locations
- 1
- Primary Endpoint
- Body Weight reduction
Study Overview
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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Investigator)
Masking Description
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.
Eligibility Criteria
- Ages
- 40 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group A - "Hep"
Hepatologist counseling providing generic lifestyle recommendations
Intervention: Hepatologic-provided recommendations (Behavioral)
Group B - "Hep + Nut"
Hepatologist counseling with the integration of tailored lifestyle recommendations, including personalized physical exercise and dietary plan, provided by a nutritionist
Intervention: Hepatologic-provided recommendations (Behavioral)
Group B - "Hep + Nut"
Hepatologist counseling with the integration of tailored lifestyle recommendations, including personalized physical exercise and dietary plan, provided by a nutritionist
Intervention: Nutritional support (Behavioral)
Group C - "Hep + Nut + Psy"
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
Intervention: Nutritional support (Behavioral)
Group C - "Hep + Nut + Psy"
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
Intervention: Hepatologic-provided recommendations (Behavioral)
Group C - "Hep + Nut + Psy"
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
Intervention: Psychological support (Behavioral)
Outcomes
Primary Outcomes
Body Weight reduction
Time Frame: From enrollment to the end of intervention at 18 months
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
Secondary Outcomes
- 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)
- Variations in Liver Stiffness(From enrollment to the end of intervention at 18 months)
- Variations in Controlled Attenuation Parameter (CAP)(From enrollment to the end of intervention at 18 months)
Investigators
Alessandro Federico
Full Professor
University of Campania Luigi Vanvitelli