Status:
COMPLETED
Behavioral Lifestyle Intervention for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Adults
Lead Sponsor:
Grand Valley State University
Collaborating Sponsors:
Gastroenterology Associates of Western Michigan
Conditions:
Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)
Metabolic Associated-dysfunction Steatohepatitis (MASH)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 metabol...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06121999
Start Date
August 17 2023
End Date
November 1 2024
Last Update
August 28 2025
Active Locations (1)
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1
Gastroenterology Associates of Western Michigan, PLC
Wyoming, Michigan, United States, 49519