Behavioral Lifestyle Intervention for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Adults
NCT ID: NCT06121999
Last Updated: 2025-08-28
Study Results
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Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2023-08-17
2024-11-01
Brief Summary
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1. How do the two interventions compare for improving weight loss, health-related quality of life (HRQOL), and FibroScan results.
2. 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Acceptance-based behavioral weight loss program (ABWL)
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.
Standard of care acceptance-based behavioral weight loss program
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.
Occupational Therapy behavioral lifestyle intervention
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.
Standard of care acceptance-based behavioral weight loss program
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.
Occupational therapy dietary and lifestyle modifications
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.
Interventions
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Standard of care acceptance-based behavioral weight loss program
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.
Occupational therapy dietary and lifestyle modifications
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Gastroenterology Associates of Western Michigan
UNKNOWN
Grand Valley State University
OTHER
Responsible Party
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Scott Truskowski
OST Department Chair, Associate Professor Occupational Science and Therapy Department
Principal Investigators
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Scott Truskowski, PhD
Role: PRINCIPAL_INVESTIGATOR
Grand Valley State University
Locations
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Gastroenterology Associates of Western Michigan, PLC
Wyoming, Michigan, United States
Countries
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References
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Other Identifiers
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23-278-H
Identifier Type: -
Identifier Source: org_study_id
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