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NCT Number: NCT06121999

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

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.

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Key information

Conditions

Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD) Behavior Body Weight Body Weight Changes Chronic Disease Digestive System Diseases Disease Attributes Fatty Liver Liver Diseases Metabolic Associated-dysfunction Steatohepatitis (MASH) Motor Activity Non-alcoholic Fatty Liver Disease Noncommunicable Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastroenterology Associates of Western Michigan, PLC

Wyoming, Michigan, 49519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care acceptance-based behavioral weight loss program

Behavioral

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.

Occupational therapy dietary and lifestyle modifications

Behavioral

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.

Primary outcomes

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

    Time frame: End of study, week 13

    The mean % of total body weight loss (%TBWL) measures the average percentage of total body weight loss (%TBWL). Possible scores range from 1 to 15%, with higher scores indicating a better outcome.

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

    Time frame: End of study, week 13

    The percentage of participants achieving a greater than or equal to 5% total body weight loss (TBWL) measures the proportion of participants who achieved the weight loss goal. Possible scores range from 1 - 100%, with higher scores indicating a better outcome.

Secondary outcomes

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

    Time frame: Baseline, week 1 compared to end of study, week 13

    The mean change of the CLDQ-NAFLD / NASH measures the average in the score of the instrument. The CLDQ-NAFLD / NASH questionnaire is an evidence-based, liver specific instrument responsive to changes in health related quality of life (HRQL). Thirty-six questions measure quality of life and the health burden related to nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). Scores can range from 36-252, with higher scores indicating a better outcome.

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

    Time frame: Baseline, week 1 compared to end of study, week 13

    The mean change of liver steatosis is measured as a controlled attenuation pattern in decibels per meter (CAP dB/m). Liver fibrosis measured as kilopascals (kPa). FibroScan liver elastography is an evidence-based, liver specific instrument that is responses to changes in liver fat (steatosis) and liver stiffness (fibrosis). The CAP dB/m score will range from 100 dB/m to 400 dB/m with lower scores indicating a better outcome. The kPA score will range from 2 kPa to 14 kPA (for non-cirrhotic patients) with lower scores indicating a better outcome.

Sponsors and collaborators

Lead sponsor

Grand Valley State University

Other

Collaborators

  • Gastroenterology Associates of Western Michigan

Registry information

Official study title

13-Week Behavioral Lifestyle Intervention for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction-associated Steatosis (MASH) in Adults: A Randomized Control Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2023
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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