NCT06121999Completed
Behavioral Lifestyle Intervention for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Adults
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
Source: ClinicalTrials.gov · Last updated 28 Aug 2025
Brief summary (registry, in English)
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: 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 28 Sept 2023
- Start date
- 17 Aug 2023
- Primary completion date
- 1 Nov 2024
- Lead sponsor
- Grand Valley State University
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06121999
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 17 Aug 2023 to the primary completion date, 1 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Completed bariatric surgery less than 12-months prior to the start of the study
Other illness
- diagnoses or the presence of other chronic liver and biliary diseases
- Presence of significant medical or psychiatric condition
- \_ Presence of cognitive impairments that would inhibit participation in the study
Other
- enrolled in a clinical trial for NAFLD or NASH
- Achieved a 5% or greater total body weight loss within 6-months of the start of 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gastroenterology Associates of Western Michigan, PLC Coordinator of this site? Confirm its status | Wyoming | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.