Behavioral Lifestyle Intervention for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Adults
- Conditions
- Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)Metabolic Associated-dysfunction Steatohepatitis (MASH)
- Registration Number
- NCT06121999
- Lead Sponsor
- Grand Valley State University
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 40
- 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.
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diagnoses or the presence of other chronic liver and biliary diseases
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enrolled in a clinical trial for NAFLD or NASH
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Completed bariatric surgery less than 12-months prior to the start of the study
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Achieved a 5% or greater total body weight loss within 6-months of the start of the study.
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Presence of significant medical or psychiatric condition
_ Presence of cognitive impairments that would inhibit participation in the study
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Individuals who are nursing, pregnant, or planning on becoming pregnant during the study.
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Individuals with a high likelihood of loss to follow-up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The percentage of participants achieving a greater than or equal to 5% total body weight loss (TBWL). End of study, week 13 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.
The mean % of total body weight loss (%TBWL) End of study, week 13 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.
- Secondary Outcome Measures
Name Time Method Mean change in the kilopascals (kPa) and controlled attenuation pattern in decibels per meter (CAP dB/m) liver FibroScan scores Baseline, week 1 compared to end of study, week 13 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.
Mean change in the Chronic Liver Disease Questionnaire - NAFLD/NASH (CLDQ-NAFLD/NASH) Baseline, week 1 compared to end of study, week 13 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.
Trial Locations
- Locations (1)
Gastroenterology Associates of Western Michigan, PLC
🇺🇸Wyoming, Michigan, United States
Gastroenterology Associates of Western Michigan, PLC🇺🇸Wyoming, Michigan, United States