Behavioral Lifestyle Intervention for Non-Alcoholic Fatty Liver Disease

Recruiting in Palo Alto (17 mi)

Overseen byScott Truskowski, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Grand Valley State University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Scott Truskowski, PhD

Principal Investigator

Grand Valley State University

Eligibility Criteria

Adults diagnosed with NAFLD or NASH, having a BMI over 25, can join this trial. They must be able to consent and visit the gastroenterology clinic in Western Michigan. People with other chronic liver diseases, enrolled in another NAFLD/NASH trial, recent bariatric surgery patients, those who've lost significant weight recently, or have serious medical/psychiatric conditions cannot participate.

Inclusion Criteria

You can give your permission in writing and by speaking to join the study.

You live in the area and are healthy enough to visit the gastroenterology clinic.

You need to be a patient at Gastroenterology Associates of Western Michigan.

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Exclusion Criteria

Enrolled in a clinical trial for NAFLD or NASH

Achieved a 5% or greater total body weight loss within 6-months of the start of the study

Individuals who are nursing, pregnant, or planning on becoming pregnant during the study

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Treatment Details

Interventions

Occupational therapy dietary and lifestyle modifications (Behavioural Intervention)
Standard of care acceptance-based behavioral weight loss program (Behavioural Intervention)

Trial OverviewThe study compares an acceptance-based behavioral weight loss program against occupational therapy lifestyle changes for MASLD/MASH (formerly known as NAFLD/NASH). It looks at which is better for weight loss, life quality improvement and liver health via FibroScan results.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Occupational Therapy behavioral lifestyle interventionExperimental Treatment2 Interventions

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.

Group II: Acceptance-based behavioral weight loss program (ABWL)Active Control1 Intervention

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.