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Behavioural Intervention

Behavioral Lifestyle Intervention for Non-Alcoholic Fatty Liver Disease

N/A

Waitlist Available

Led By Scott Truskowski, PhD

Research Sponsored by Grand Valley State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with NAFLD or NASH and have a body mass index greater than 25

Be older than 18 years old

Must not have

Diagnoses or the presence of other chronic liver and biliary diseases

Presence of significant medical or psychiatric condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 1 compared to end of study, week 13

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare a weight loss program and occupational therapy to see if they improve weight, quality of life, and liver health in adults with metabolic associated-dysfunction steatotic liver disease and steatohepatitis.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Since the interventions are non-medical (behavioral and lifestyle modifications), typical drug side effects aren't expected. However, participants may experience stress or discomfort from dietary changes and new routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have NAFLD or NASH and my BMI is over 25.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a chronic liver or biliary disease.

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I have a serious health or mental health condition.

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I do not have cognitive impairments that prevent me from participating in studies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 1 compared to end of study, week 13

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 1 compared to end of study, week 13

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1 compared to end of study, week 13 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The mean % of total body weight loss (%TBWL)

The percentage of participants achieving a greater than or equal to 5% total body weight loss (TBWL).

Secondary study objectives

Mean change in the Chronic Liver Disease Questionnaire - NAFLD/NASH (CLDQ-NAFLD/NASH)

Mean change in the kilopascals (kPa) and controlled attenuation pattern in decibels per meter (CAP dB/m) liver FibroScan scores

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met