Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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The purpose of this research study is to find out about the usefulness of mindfulness for weight loss and improvement of physical and mental health in people who have non-alcoholic fatty liver disease (NAFLD).

Detailed Description
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Adding mindfulness to lifestyle changes for weight loss may improve fatty liver disease in particular and overall health and well-being in general by helping sustain weight loss and maintain a healthy lifestyle. This study will allow researchers to learn more about it. Non-alcoholic fatty liver disease is a condition where there is accumulation of excess fat in the liver of people who drink little or no alcohol. It is part of the metabolic syndrome characterized by diabetes, or pre-diabetes (insulin resistance), being overweight or obese, elevated blood lipids, as well as high blood pressure, all are risk factors for the disease. In this study, participants will receive usual care, and in addition, they may be asked to participate in a mindfulness-based stress reduction program for 8 weeks. Usual care involves the routine clinic follow up visits and routine lab tests and imaging studies.

Official Title
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Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease: Beyond the Paradigm of Weight Loss.

Conditions
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Non-Alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic, Obesity

Intervention / Treatment
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* Behavioral: Mindfulness Based Stress Reduction (MBSR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of NAFLD and ALT >35 U/dl. At least 2 features of Metabolic syndrome (defined by Adult Treatment Panel III (2005 revision)). Age 18-80 years. BMI ≥25 Kg/m2. Capable of providing written or signed informed consent. Exclusion Criteria: Any known cause of liver disease other than NAFLD as confirmed by patient's history, laboratory data, and/or histological findings. Decompensated liver cirrhosis based on laboratory data and clinical manifestations (varices, ascites, or encephalopathy). Any previous experimental interventional treatment of NAFLD or NASH within the past 3 months. Pre-existing diseases/conditions that could interfere with the results or the completion of this trial based on the investigator's judgment. Unstable metabolic syndrome and other serious chronic medical conditions. Unstable type 2 diabetes (any of the following): Requiring medication adjustment within the last 3 months. Patients requiring GLP-1 agonists treatment. No more than 10% modification in insulin dose if on insulin. If on SGLT-2 inhibitors, need to be on stable dose with more than 5% weight loss in the last 3 months. Unable to adhere to out-patient clinic management program. Do not speak English on a daily-user level. Pregnant or planning to become pregnant within the following 6 months. Active substance use disorder. Does not accept follow-ups over 1 year from time of inclusion (T0). Inmates.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Based Stress Reduction (MBSR)<br> | Behavioral: Mindfulness Based Stress Reduction (MBSR)<br>* Participants will be asked to attend group meetings for mindfulness training. Each meeting will last approximately one hour and will take place online via Zoom. The meetings will occur on a weekly basis, over an 8-week period.<br>|
| No Intervention: Standard of Care (SOC)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total body weight | Relative change (%) in total body weight at 6 months (T1) from baseline (T0). | Baseline to 6 months | 
| Change in bilirubin | Relative change (%) in bilirubin at 6 months (T1) from baseline (T0). | Baseline to 6 months | 
| Change in alanine transaminase (ALT) | Relative change (%) in ALT at 6 months (T1) from baseline (T0). | Baseline to 6 months | 
| Change in aspartate transaminase (AST) | Relative change (%) in AST at 6 months (T1) from baseline (T0). | Baseline to 6 months | 
| Change in alkaline phosphatase (ALP) | Relative change (%) in ALP at 6 months (T1) from baseline (T0). | Baseline to 6 months | 
| Change in c-reactive protein (CRP) | Relative change (%) in CRP at 6 months (T1) from baseline (T0). | Baseline to 6 months | 
| Change in Fibrosis-4 Index (FIB-4) | Relative change (%) in FIB-4 at 6 months (T1) from baseline (T0). | Baseline to 6 months | 
| Change in Enhanced Liver Fibrosis test (ELF) | Relative change (%) in ELF at 6 months (T1) from baseline (T0). | Baseline to 6 months | 
| Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4) | Relative change (%) in NIS4 at 6 months (T1) from baseline (T0). | Baseline to 6 months | 
| Change in liver stiffness | Relative change (%) in liver stiffness as measured by transient elastography at 6 months (T1) from baseline (T0). | Baseline to 6 months | 
| Change in hepatic fat deposition | Relative change (%) in hepatic fat deposition as measured by magnetic resonance imaging (MRI) with proton density fat fraction (PDFF) at 6 months (T1) from baseline (T0). | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total body weight | Relative change (%) in total body weight at 1 year (T2) from 6 months (T1) and baseline (T0). | Baseline to 12 months | 
| Change in bilirubin | Relative change (%) in bilirubin at 1 year (T2) from 6 months (T1) and baseline (T0). | Baseline to 12 months | 
| Change in alanine transaminase (ALT) | Relative change (%) in ALT at 1 year (T2) from 6 months (T1) and baseline (T0). | Baseline to 12 months | 
| Change in aspartate transaminase (AST) | Relative change (%) in AST at 1 year (T2) from 6 months (T1) and baseline (T0). | Baseline to 12 months | 
| Change in c-reactive protein (CRP) | Relative change (%) in CRP at 1 year (T2) from 6 months (T1) and baseline (T0). | Baseline to 12 months | 
| Change in Fibrosis-4 Index (FIB-4) | Relative change (%) in FIB-4 at 1 year (T2) from 6 months (T1) and baseline (T0). | Baseline to 12 months | 
| Change in Enhanced Liver Fibrosis test (ELF) | Relative change (%) in ELF at 1 year (T2) from 6 months (T1) and baseline (T0). | Baseline to 12 months | 
| Change in Nonalcoholic steatohepatitis related biomarkers score (NIS4) | Relative change (%) in NIS4 at 1 year (T2) from 6 months (T1) and baseline (T0). | Baseline to 12 months | 
| Change in alkaline phosphatase (ALP) | Relative change (%) in ALP at 1 year (T2) from 6 months (T1) and baseline (T0). | Baseline to 12 months | 
| Change in hepatic fat deposition | Relative change (%) in hepatic fat deposition as measured by magnetic resonance imaging (MRI) with proton density fat fraction (PDFF) at 1 year (T2) from 6 months (T1) and baseline (T0). | Baseline to 12 months |