Behavioral Lifestyle Intervention for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Adults
United States24 participantsStarted 2023-08-17
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The mean % of total body weight loss (%TBWL)
Timeframe: End of study, week 13
2
The percentage of participants achieving a greater than or equal to 5% total body weight loss (TBWL).