Lifestyle Modification in the Treatment of NAFLD.

Study Overview
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Brief Summary
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The project will study the impact of individually tailored lifestyle counselling compared to standard care on the parameters of NAFLD/NASH in patients with metabolic syndrome. The factors affecting the outcome (including clinical and laboratory parameters and microbiome profiling) will be evaluated.

Detailed Description
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Non-alcoholic fatty liver disease (NAFLD), the hepatic manifestation of a metabolic syndrome, is a leading cause of chronic liver disease worldwide. NAFLD is associated with type 2 diabetes, obesity and genetic factors. Despite intensive effort and numerous trials, as of today there is no approved treatment for NAFLD. Weight reduction is recommended, but no long-term control study assessing the evolution of NAFLD/NASH (non-alcoholic steatohepatitis) during lifestyle modification is available. The main objective of presented project is to compare the progression of NAFLD/NASH in patients with metabolic syndrome randomly assigned to a standard care or a professional lifestyle modification counselling during a 1-yr follow-up. The investigators hypothesize that professionally tailored life-style counselling in patient with metabolic syndrome and NAFLD will improve liver fat content and other non-invasive parameters of liver disease, and factors (including gut microbiota) affecting progression/regression of NAFLD will be identified.

Official Title
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Complex Lifestyle Modification in the Treatment of Non-alcoholic Fatty Liver Disease

Conditions
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NAFLD

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals with NAFLD and metabolic syndrome Exclusion Criteria: Etiology of liver disease other than NAFLD. Presence of malignant disease. Uncontrolled cardiovascular disease Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with NAFLD and metabolic syndrome will be randomly assigned to a standard care or a professional lifestyle modification counselling during a 1-yr follow-up.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Professional lifestyle modification counselling (behavioral therapy)<br>Lifestyle intervention will be based on CBT (cognitive behavioral therapy) and mindfulness, especially mindful eating by professional organisation STOB. | Behavioral: Cognitive behavioral therapy<br>* Subjects will receive professional lifestyle intervention conducted by STOB organization. Using CBT and the so-called third wave of CBT, especially mindfulness, the patients will be guided by certified experts to increase motivation and to change eating and exercise habits, which will be mapped before and after the intervention.<br>|
| No Intervention: standard care<br>Patients will have standard care with regular visits at an outpatient Department of Hepatology. Standard recommendations of lifestyle change and weight reduction will be given by hepatologists. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of CBT on liver fat content | The effect of CBT on liver fat content measured by MRS (percentual change from baseline). | 12 months | 
| The effect of CBT on inflammatory parameters | The effect of CBT on inflammatory biochemical parameters (percentual change from baseline). | 12 months | 
| The effect of CBT on liver fibrosis | The effect of CBT on liver fibrosis measured by elastography (percentual change from baseline). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAFLD, Cognitive behavioral therapy