Clinical trial NCT06121999: Behavioral Lifestyle Intervention for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)
Metabolic Associated-dysfunction Steatohepatitis (MASH)
Keywords: weight loss
lifestyle modification
behavior change
liver disease
physical activity
nonalcoholic fatty liver disease (NAFLD)
nonalcoholic steatohepatitis (NASH)
noncommunicable disease
chronic disease
obesity
Lead sponsor: Grand Valley State University
Sponsor class: OTHER
Collaborators: name: Sharyn Coates, Dr. OT, OTRL
First posted: 2023-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the control or experimental intervention on a rolling basis.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The mean % of total body weight loss (%TBWL)
timeFrame: End of study, week 13
measure: The percentage of participants achieving a greater than or equal to 5% total body weight loss (TBWL).
timeFrame: End of study, week 13
Secondary outcomes:
measure: Mean change in the Chronic Liver Disease Questionnaire - NAFLD/NASH (CLDQ-NAFLD/NASH)
timeFrame: Baseline, week 1 compared to end of study, week 13
measure: Mean change in the kilopascals (kPa) and controlled attenuation pattern in decibels per meter (CAP dB/m) liver FibroScan scores
timeFrame: Baseline, week 1 compared to end of study, week 13
Other outcomes:
Locations:
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, PLC
state: Michigan
Study officials:
affiliation: Grand Valley State University
name: Scott Truskowski, PhD
role: PRINCIPAL_INVESTIGATOR
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