Behavioral Lifestyle Intervention for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Adults

Grand Valley State University

Status: Invitation-only

Conditions: Metabolic Associated-dysfunction Steatohepatitis (MASH); Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)

Treatments: Behavioral: Standard of care acceptance-based behavioral weight loss program; Behavioral: Occupational therapy dietary and lifestyle modifications

Study type: Interventional

Funder types: Other

Identifiers

NCT06121999

23-278-H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Acceptance-based behavioral weight loss program (ABWL)

Active Comparator group

Description:

Participants meet individually for 30 - 60 minutes with an occupational therapist for 13 consecutive weeks at a gastroenterology office. Outcome data is collected at baseline (visit 1) and at the end of the study (visit 13), Participants work on two modules per week in-between visits. During visits the participants' weight is recorded, module contents and worksheet information is reviewed and recorded, and suggestions are made as indicated in the clinician guide.

Treatment:

Behavioral: Standard of care acceptance-based behavioral weight loss program

Occupational Therapy behavioral lifestyle intervention

Experimental group

Description:

Participants meet individually for 60-90 minutes with an occupational therapist for 13 consecutive weeks at a gastroenterology office. Outcome data is collected at baseline (visit 1) and at the end of the study (visit 13). The Model of Human Occupation Screening Tool (MOHOST) and Role Checklist version 3 (RCv3) assessment are also used for intervention in the areas of motivation for occupation, pattern of occupation, communication & interaction skills, motor skills, process skills, and environment. Participants are also educated about practice guidelines for MASLD/MASH such as a Mediterranean (MED) diet and a personalized exercise plan. In-between visits, participants work on two modules of the control intervention and implement dietary and lifestyle modifications discussed during the visit.

Treatment:

Behavioral: Occupational therapy dietary and lifestyle modifications

Behavioral: Standard of care acceptance-based behavioral weight loss program