Behavioral Lifestyle Intervention for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Adults

Study Overview
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Brief Summary
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The goal of this randomized control trial study is to compare an acceptance-based weight loss program with an occupational therapy behavioral lifestyle modification intervention in adults with metabolic associated-dysfunction steatotic liver disease (MASLD) and metabolic associated-dysfunction steatohepatitis (MASH). Formerly known as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). The main questions the study aims to answer are: How do the two interventions compare for improving weight loss, health-related quality of life (HRQOL), and FibroScan results. Examine the role of occupational therapy on a multidisciplinary team for the treatment of MASLD and MASH. Participants will meet with an occupational therapist for individual, 60-minute visits for 13 consecutive weeks. Each week participants will be weighed and then engage in a personalized intervention. At the end of the visit participants will be given worksheets and information to work on in-between visits. Researchers will compare the intervention with an acceptance-based behavioral weight loss program that is commonly used for people with obesity and or type 2 diabetes.

Detailed Description
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The research design is a pretest-posttest randomized control trial. Forty participants will be enrolled on a rolling bases and then assigned to one of two interventions. Occupational therapy with an acceptance-based behavioral weight loss program or only the acceptance-based behavioral weight loss program. Participants for both interventions will meet with an occupational therapist individually for 60 minutes for 13 consecutive weeks. Participants will be given modules from the weight loss program and worksheets to work on in-between sessions. Individuals in the occupational therapy intervention will also work on creating and individualized physical activity plan and implementation of the Mediterranean or Med Diet. At the beginning of each visit, participants will be weighed. During the visit their food logs and worksheets will be reviewed with the participant. Additional measurements during the 1st, 7th, and 13th visit include a liver FibroScan, waist measurement, and completion of questionnaires and assessments.

Official Title
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13-Week Behavioral Lifestyle Intervention for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction-associated Steatosis (MASH) in Adults: A Randomized Control Trial

Conditions
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Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD), Metabolic Associated-dysfunction Steatohepatitis (MASH)

Intervention / Treatment
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* Behavioral: Standard of care acceptance-based behavioral weight loss program
* Behavioral: Occupational therapy dietary and lifestyle modifications


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with NAFLD or NASH and have a body mass index greater than 25 Able to provide written and verbal consent to participate in the study Live in the community and able their health status is such that they can be seen in the gastroenterology clinical practice Must be patients of Gastroenterology Associates of Western Michigan. Exclusion Criteria: diagnoses or the presence of other chronic liver and biliary diseases enrolled in a clinical trial for NAFLD or NASH Completed bariatric surgery less than 12-months prior to the start of the study Achieved a 5% or greater total body weight loss within 6-months of the start of the study. Presence of significant medical or psychiatric condition _ Presence of cognitive impairments that would inhibit participation in the study Individuals who are nursing, pregnant, or planning on becoming pregnant during the study. Individuals with a high likelihood of loss to follow-up

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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Accepts Healthy Volunteers

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: Participants will be randomly assigned to the control or experimental intervention on a rolling basis.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acceptance-based behavioral weight loss program (ABWL)<br>Participants meet individually for 30 - 60 minutes with an occupational therapist for 13 consecutive weeks at a gastroenterology office. Outcome data is collected at baseline (visit 1) and at the end of the study (visit 13), Participants work on two modules per week in-between visits. During visits the participants' weight is recorded, module contents and worksheet information is reviewed and recorded, and suggestions are made as indicated in the clinician guide. | Behavioral: Standard of care acceptance-based behavioral weight loss program<br>* Evidence-based, structured weight loss program for adults with co-morbid conditions of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). Published as a workbook for participants and a clinician guide, the intervention consists of twenty-five sessions or modules with accompanying worksheets. Each session covers specific acceptance-based behavioral skills to implement and build upon in subsequent sessions.<br>|
| Experimental: Occupational Therapy behavioral lifestyle intervention<br>Participants meet individually for 60-90 minutes with an occupational therapist for 13 consecutive weeks at a gastroenterology office. Outcome data is collected at baseline (visit 1) and at the end of the study (visit 13). The Model of Human Occupation Screening Tool (MOHOST) and Role Checklist version 3 (RCv3) assessment are also used for intervention in the areas of motivation for occupation, pattern of occupation, communication & interaction skills, motor skills, process skills, and environment. Participants are also educated about practice guidelines for MASLD/MASH such as a Mediterranean (MED) diet and a personalized exercise plan. In-between visits, participants work on two modules of the control intervention and implement dietary and lifestyle modifications discussed during the visit. | Behavioral: Standard of care acceptance-based behavioral weight loss program<br>* Evidence-based, structured weight loss program for adults with co-morbid conditions of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). Published as a workbook for participants and a clinician guide, the intervention consists of twenty-five sessions or modules with accompanying worksheets. Each session covers specific acceptance-based behavioral skills to implement and build upon in subsequent sessions.<br>Behavioral: Occupational therapy dietary and lifestyle modifications<br>* Occupational therapy Model of Human Occupation Screening Tool (MOHOST) and Role Checklist version 3 (RCv3) assessments identify areas of need for personalizing participant implementation of the standard of care acceptance-based behavioral weight loss program. Areas of need may include physical activity limitations to be addressed in an exercise plan or social determinants of health that are barriers to dietary and lifestyle modifications. Dietary and lifestyle modifications are based on American Gastroenterology Association (AGA) recommendations published in practice guidelines for this population. Recommendations include a Mediterranean diet, improved self-management of co-morbid chronic conditions, and a total body weight loss of five to ten percent at 1 - 2 pound weekly increments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean % of total body weight loss (%TBWL) | The mean % of total body weight loss (%TBWL) measures the average percentage of total body weight loss (%TBWL). Possible scores range from 1 to 15%, with higher scores indicating a better outcome. | End of study, week 13 | 
| The percentage of participants achieving a greater than or equal to 5% total body weight loss (TBWL). | The percentage of participants achieving a greater than or equal to 5% total body weight loss (TBWL) measures the proportion of participants who achieved the weight loss goal. Possible scores range from 1 - 100%, with higher scores indicating a better outcome. | End of study, week 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in the Chronic Liver Disease Questionnaire - NAFLD/NASH (CLDQ-NAFLD/NASH) | The mean change of the CLDQ-NAFLD / NASH measures the average in the score of the instrument. The CLDQ-NAFLD / NASH questionnaire is an evidence-based, liver specific instrument responsive to changes in health related quality of life (HRQL). Thirty-six questions measure quality of life and the health burden related to nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). Scores can range from 36-252, with higher scores indicating a better outcome. | Baseline, week 1 compared to end of study, week 13 | 
| Mean change in the kilopascals (kPa) and controlled attenuation pattern in decibels per meter (CAP dB/m) liver FibroScan scores | The mean change of liver steatosis is measured as a controlled attenuation pattern in decibels per meter (CAP dB/m). Liver fibrosis measured as kilopascals (kPa). FibroScan liver elastography is an evidence-based, liver specific instrument that is responses to changes in liver fat (steatosis) and liver stiffness (fibrosis). The CAP dB/m score will range from 100 dB/m to 400 dB/m with lower scores indicating a better outcome. The kPA score will range from 2 kPa to 14 kPA (for non-cirrhotic patients) with lower scores indicating a better outcome. | Baseline, week 1 compared to end of study, week 13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, lifestyle modification, behavior change, liver disease, physical activity