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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 / 1Eligibility criteria met

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Who is running the clinical trial?

Grand Valley State UniversityLead Sponsor

12 Previous Clinical Trials

8,639 Total Patients Enrolled

Scott Truskowski, PhDPrincipal InvestigatorGrand Valley State University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more openings for this research program?

"According to clinicaltrials.gov, as of 11/2/2023 this study is not currently seeking candidates for enrollment. Despite this particular trial's conclusion, there are still 397 other medical trials actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Scott Truskowski 2023. "Behavioral Lifestyle Intervention for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06121999.

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