MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseCoCoNutNCT07366463
Integrating Hepatological, Nutritional, and Psychological Support as a Multidisciplinary Management to Improve Long-term Clinical Outcomes in MASLD
A study testing Hepatologic-provided recommendations, Nutritional support and Psychological support in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and MASLD, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD, Cardiovascular Events
- What is being tested?
- Hepatologic-provided recommendations, Nutritional support and Psychological support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 9Show fewer
- chronic systemic inflammatory diseases,
- eating disorders (ED)
- other psychiatric disorders potentially invalidating the consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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]
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.
Read the 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
- Being tested
- Hepatologic-provided recommendations, Nutritional support, Psychological support
- Keywords
- Multidisciplinary, Nutrition, Cognitive behavioral therapy, Personalized medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatologic-provided recommendationsBehavioural
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).
Nutritional supportBehavioural
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.
Psychological supportBehavioural
Also called Cognitive behavioral therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A - "Hep" | Active comparator | Hepatologist counseling providing generic lifestyle recommendations Receives: 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 Receives: 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 Receives: Behavioral: Hepatologic-provided recommendations; Behavioral: Nutritional support; Behavioral: Psychological support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of intervention at 18 months
Secondary outcomes (7)
Variations in anthropometric parameters
After 18 months, at the end of the study, in the experimental cohort compared with the standard of care, to report a statistically significant improvement of Body Mass Index (BMI) and Waist-to-hip ratio (WHR)].
Measured: From enrollment to the end of intervention at 18 months
Different risk of acute cardiovascular events
In the experimental cohort compared with the standard of care, to highlight significant changes in cardiovascular risk by using the Atherosclerotic Cardiovascular Disease (ASCVD) risk score, adopting the calculator available online on the American College of Cardiology website (https://tools.acc.org/ascvd-risk-estimator-plus) (accessed on 4th June 2024), considering > 7.5% the threshold defining a significant risk.
Measured: From enrollment to the end of intervention at 18 months
Variations in metabolic variables (glycometabolic)
After the 18 months, at the end of the study, in the experimental cohort compared with the standard of care, to report a statistically significant improvement of Homeostatic Model Assessment for Insulin Resistance (HOMA-IR),
Measured: From enrollment to the end of intervention at 18 months
Variations in metabolic parameters (lipidic variables)
After the 18 months, at the end of the study, in the experimental cohort compared with the standard of care, to report a statistically significant improvement of high-density lipoprotein cholesterol (HDL)],
Measured: From enrollment to the end of intervention at 18 months
Variations in body composition
After 18 months, at the end of the study, in the experimental cohort compared with the standard of care, to report a statistically significant improvement of body composition parameters [free-fat mass (FFM) and fat mass (FM)].
Measured: From enrollment to the end of intervention at 18 months
Variations in Liver Stiffness
After the 18 months, at the end of the study, in the experimental cohort compared with the standard of care, to report a statistically significant improvement of Liver Stiffness Measurement (LSM).
Measured: From enrollment to the end of intervention at 18 months
Variations in Controlled Attenuation Parameter (CAP)
After the 18 months, at the end of the study, in the experimental cohort compared with the standard of care, to report a statistically significant improvement of Controlled Attenuation Parameter (CAP).
Measured: From enrollment to the end of intervention at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jul 2023
- Primary completion1 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Federico, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366463
- Sponsor's protocol ID
- 0016368/i
- Acronym
- CoCoNut
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39992295M. 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)
Dallio M, Romeo M, Di Nardo F, Napolitano C, Coppola A, Mazzarella C, Vaia P, Basile C, Federico A. 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. Clin Nutr. 2026 Sep 18;66:106800. doi: 10.1016/j.clnu.2026.106800. Online ahead of print.
PubMed 42805146
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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]
- ClinicalTrials.gov ID
- NCT07366463
- Acronym / sponsor ID
- CoCoNut / 0016368/i
- Conditions
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD, Cardiovascular Events
- Keywords
- Multidisciplinary, Nutrition, Cognitive behavioral therapy, Personalized medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A - "Hep" | Active comparator | Behavioral: Hepatologic-provided recommendationsHepatologist counseling providing generic lifestyle recommendations |
| Group B - "Hep + Nut" | Active comparator | Behavioral: Hepatologic-provided recommendations, Behavioral: Nutritional supportHepatologist counseling with the integration of tailored lifestyle recommendations, including personalized physical exercise and dietary plan, provided by a nutritionist |
| Group C - "Hep + Nut + Psy" | Experimental | Behavioral: Hepatologic-provided recommendations, Behavioral: Nutritional support, Behavioral: Psychological supportHepatologist 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 |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatologic-provided recommendationsHepatologic 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). | Behavioural | Group A - "Hep", Group B - "Hep + Nut", Group C - "Hep + Nut + Psy" |
| Nutritional supportNutritional 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. | Behavioural | Group B - "Hep + Nut", Group C - "Hep + Nut + Psy" |
| Psychological supportAlso: Cognitive behavioral therapyThe 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. | Behavioural | Group C - "Hep + Nut + Psy" |
Primary outcome
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
7 secondary outcomes
Variations in anthropometric parameters
Time frame: From enrollment to the end of intervention at 18 months
Different risk of acute cardiovascular events
Time frame: From enrollment to the end of intervention at 18 months
Variations in metabolic variables (glycometabolic)
Time frame: From enrollment to the end of intervention at 18 months
Variations in metabolic parameters (lipidic variables)
Time frame: From enrollment to the end of intervention at 18 months
Variations in body composition
Time frame: From enrollment to the end of intervention at 18 months
Variations in Liver Stiffness
Time frame: From enrollment to the end of intervention at 18 months
Variations in Controlled Attenuation Parameter (CAP)
Time frame: From enrollment to the end of intervention at 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 39992295Romeo 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.
- Results publicationM. 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)
- Derived from this study: PubMed 42805146Dallio M, Romeo M, Di Nardo F, Napolitano C, Coppola A, Mazzarella C, Vaia P, Basile C, Federico A. 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. Clin Nutr. 2026 Sep 18;66:106800. doi: 10.1016/j.clnu.2026.106800. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatologic-provided recommendations, Nutritional support and Psychological support in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and MASLD, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight reduction (time frame: From enrollment to the end of intervention at 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07366463, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.