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

NCT ID: NCT05130346

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2023-12-31

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mindfulness Based Stress Reduction (MBSR)

Group Type: EXPERIMENTAL

Mindfulness Based Stress Reduction (MBSR)

Intervention Type: BEHAVIORAL

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.

Standard of Care (SOC)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness Based Stress Reduction (MBSR)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Confirmed diagnosis of NAFLD and ALT >35 U/dl.

2. At least 2 features of Metabolic syndrome (defined by Adult Treatment Panel III (2005 revision)).

3. Age 18-80 years.

4. BMI ≥25 Kg/m2.

5. Capable of providing written or signed informed consent.

Exclusion Criteria

1. Any known cause of liver disease other than NAFLD as confirmed by patient's history, laboratory data, and/or histological findings.

2. Decompensated liver cirrhosis based on laboratory data and clinical manifestations (varices, ascites, or encephalopathy).

3. Any previous experimental interventional treatment of NAFLD or NASH within the past 3 months.

4. Pre-existing diseases/conditions that could interfere with the results or the completion of this trial based on the investigator's judgment.

5. Unstable metabolic syndrome and other serious chronic medical conditions.

6. 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.

7. Unable to adhere to out-patient clinic management program.

8. Do not speak English on a daily-user level.

9. Pregnant or planning to become pregnant within the following 6 months.

10. Active substance use disorder.

11. Does not accept follow-ups over 1 year from time of inclusion (T0).

12. Inmates.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arun J Sanyal, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20023471

Identifier Type: -

Identifier Source: org_study_id