Behavioral Lifestyle Intervention for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Adults
Study Details
Study Description
Brief 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:
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How do the two interventions compare for improving weight loss, health-related quality of life (HRQOL), and FibroScan results.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Acceptance-based behavioral weight loss program (ABWL) 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. |
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.
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| Experimental: Occupational Therapy behavioral lifestyle intervention 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. |
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.
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Outcome Measures
Primary Outcome Measures
- The mean % of total body weight loss (%TBWL) [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.
- The percentage of participants achieving a greater than or equal to 5% total body weight loss (TBWL). [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 Outcome Measures
- Mean change in the Chronic Liver Disease Questionnaire - NAFLD/NASH (CLDQ-NAFLD/NASH) [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.
- Mean change in the kilopascals (kPa) and controlled attenuation pattern in decibels per meter (CAP dB/m) liver FibroScan scores [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed with NAFLD or NASH and have a body mass index greater than 25
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Able to provide written and verbal consent to participate in the study
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Live in the community and able their health status is such that they can be seen in the gastroenterology clinical practice
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Must be patients of Gastroenterology Associates of Western Michigan.
Exclusion Criteria:
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diagnoses or the presence of other chronic liver and biliary diseases
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enrolled in a clinical trial for NAFLD or NASH
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Completed bariatric surgery less than 12-months prior to the start of the study
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Achieved a 5% or greater total body weight loss within 6-months of the start of the study.
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Presence of significant medical or psychiatric condition
_ Presence of cognitive impairments that would inhibit participation in the study
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Individuals who are nursing, pregnant, or planning on becoming pregnant during the study.
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Individuals with a high likelihood of loss to follow-up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gastroenterology Associates of Western Michigan, PLC | Wyoming | Michigan | United States | 49519 |
Sponsors and Collaborators
- Grand Valley State University
Investigators
- Principal Investigator: Scott Truskowski, PhD, Grand Valley State University
Study Documents (Full-Text)
None provided.More Information
Publications
- Balakrishnan M, Liu K, Schmitt S, Heredia NI, Sisson A, Montealegre JR, Hernaez R, Kanwal F, Foreyt J. Behavioral weight-loss interventions for patients with NAFLD: A systematic scoping review. Hepatol Commun. 2023 Aug 3;7(8):e0224. doi: 10.1097/HC9.0000000000000224. eCollection 2023 Aug 1.
- Edgelow MM, MacPherson MM, Arnaly F, Tam-Seto L, Cramm HA. Occupational therapy and posttraumatic stress disorder: A scoping review. Can J Occup Ther. 2019 Apr;86(2):148-157. doi: 10.1177/0008417419831438. Epub 2019 Apr 23.
- Forman EM, Butryn ML. A new look at the science of weight control: how acceptance and commitment strategies can address the challenge of self-regulation. Appetite. 2015 Jan;84:171-80. doi: 10.1016/j.appet.2014.10.004. Epub 2014 Oct 16.
- Keating SE, Sabag A, Hallsworth K, Hickman IJ, Macdonald GA, Stine JG, George J, Johnson NA. Exercise in the Management of Metabolic-Associated Fatty Liver Disease (MAFLD) in Adults: A Position Statement from Exercise and Sport Science Australia. Sports Med. 2023 Sep 11. doi: 10.1007/s40279-023-01918-w. Online ahead of print.
- Meidert U, Bonsaksen T, Scott PJ. A study of measuring participation according to the International Classification of Functioning, Disability and Health with the Revised Role Checklist. Clin Rehabil. 2018 Nov;32(11):1530-1539. doi: 10.1177/0269215518782339. Epub 2018 Jun 25.
- Mobasheri N, Ghahremani L, Fallahzadeh Abarghooee E, Hassanzadeh J. Lifestyle Intervention for Patients with Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial Based on the Theory of Planned Behavior. Biomed Res Int. 2022 Sep 12;2022:3465980. doi: 10.1155/2022/3465980. eCollection 2022.
- Nielsen SS, Skou ST, Larsen AE, Polianskis R, Pawlak WZ, Vaegter HB, Sondergaard J, Christensen JR. Occupational therapy lifestyle intervention added to multidisciplinary treatment for adults living with chronic pain: a feasibility study. BMJ Open. 2022 Sep 17;12(9):e060920. doi: 10.1136/bmjopen-2022-060920.
- Park J, Gross DP, Rayani F, Norris CM, Roberts MR, James C, Guptill C, Esmail S. Model of Human Occupation as a framework for implementation of Motivational Interviewing in occupational rehabilitation. Work. 2019;62(4):629-641. doi: 10.3233/WOR-192895.
- Younossi ZM, Stepanova M, Henry L, Racila A, Lam B, Pham HT, Hunt S. A disease-specific quality of life instrument for non-alcoholic fatty liver disease and non-alcoholic steatohepatitis: CLDQ-NAFLD. Liver Int. 2017 Aug;37(8):1209-1218. doi: 10.1111/liv.13391. Epub 2017 Mar 13.
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