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

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.

Conditions

• Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)
• Metabolic Associated-dysfunction Steatohepatitis (MASH)

Interventions

BEHAVIORAL

Standard of care acceptance-based behavioral weight loss program

Evidence-based, structured weight loss program for adults with co-morbid conditions of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). Published as a workbook for participants and a clinician guide, the intervention consists of twenty-five sessions or modules with accompanying worksheets. Each session covers specific acceptance-based behavioral skills to implement and build upon in subsequent sessions.

BEHAVIORAL

Occupational therapy dietary and lifestyle modifications

Occupational therapy Model of Human Occupation Screening Tool (MOHOST) and Role Checklist version 3 (RCv3) assessments identify areas of need for personalizing participant implementation of the standard of care acceptance-based behavioral weight loss program. Areas of need may include physical activity limitations to be addressed in an exercise plan or social determinants of health that are barriers to dietary and lifestyle modifications. Dietary and lifestyle modifications are based on American Gastroenterology Association (AGA) recommendations published in practice guidelines for this population. Recommendations include a Mediterranean diet, improved self-management of co-morbid chronic conditions, and a total body weight loss of five to ten percent at 1 - 2 pound weekly increments.

Sponsors & Collaborators

• Gastroenterology Associates of Western Michigan

  collaborator UNKNOWN

• Grand Valley State University

  lead OTHER

Principal Investigators

• Scott Truskowski, PhD · Grand Valley State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-08-17

Primary Completion

2024-11-01

Completion

2024-11-01

Countries

• United States

Study Locations