Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)NCT06121999
Behavioral Lifestyle Intervention for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Adults
A study testing Occupational therapy dietary and lifestyle modifications in people with Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD) and Metabolic Associated-dysfunction Steatohepatitis (MASH), run by Grand Valley State University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD), Metabolic Associated-dysfunction Steatohepatitis (MASH)
- What is being tested?
- Occupational therapy dietary and lifestyle modifications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Gastroenterology Associates of Western Michigan, PLC
Wyoming, Michigan, 49519
About this study
Official 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
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:
- How do the two interventions compare for improving weight loss, health-related quality of life (HRQOL), and FibroScan results.
- Examine the role of occupational therapy on a multidisciplinary team for the treatment of MASLD and MASH.
Read more
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.
Read the 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.
- Conditions
- Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD), Metabolic Associated-dysfunction Steatohepatitis (MASH)
- Being tested
- Standard of care acceptance-based behavioral weight loss program, Occupational therapy dietary and lifestyle modifications
- Keywords
- weight loss, lifestyle modification, behavior change, liver disease, physical activity, nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), noncommunicable disease, chronic disease, obesity
- Medical subject headings
- Weight Loss, Liver Diseases, Motor Activity, Non-alcoholic Fatty Liver Disease, Noncommunicable Diseases, Chronic Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care acceptance-based behavioral weight loss programBehavioural
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 modificationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance-based behavioral weight loss program (ABWL) | Active comparator | 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. Receives: Behavioral: Standard of care acceptance-based behavioral weight loss program |
| Occupational Therapy behavioral lifestyle intervention | Experimental | 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. Receives: Behavioral: Standard of care acceptance-based behavioral weight loss program; Behavioral: Occupational therapy dietary and lifestyle modifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean % of total body weight loss (%TBWL)
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.
Measured: End of study, week 13
The percentage of participants achieving a greater than or equal to 5% total body weight loss (TBWL).
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.
Measured: End of study, week 13
Secondary outcomes (2)
Mean change in the Chronic Liver Disease Questionnaire - NAFLD/NASH (CLDQ-NAFLD/NASH)
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.
Measured: Baseline, week 1 compared to end of study, week 13
Mean change in the kilopascals (kPa) and controlled attenuation pattern in decibels per meter (CAP dB/m) liver FibroScan scores
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.
Measured: Baseline, week 1 compared to end of study, week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start17 Aug 2023
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to the control or experimental intervention on a rolling basis.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grand Valley State University
- Sponsor type
- University, hospital or other
- Collaborators
- Gastroenterology Associates of Western Michigan
- Responsible party
- Principal investigator, Scott Truskowski, Grand Valley State University
- Investigators
- Scott Truskowski, PhD, Principal investigator, Grand Valley State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121999
- Sponsor's protocol ID
- 23-278-H
- Status last verified
- Aug 2025
- First submitted
- 28 Sep 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant identification information will be de-identified. The de-identified data will be shared.
Publications
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.
PubMed 25445199Balakrishnan 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.
PubMed 37534947Keating 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 Dec;53(12):2347-2371. doi: 10.1007/s40279-023-01918-w. Epub 2023 Sep 11.
PubMed 37695493Park 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.
PubMed 31104046Edgelow 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.
PubMed 31014080Nielsen 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.
PubMed 36115674Meidert 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.
PubMed 29938529Mobasheri 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.
PubMed 36132088Younossi 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.
PubMed 28211165Gu Y, Zhou R, Kong T, Zhang W, Chen Y, Wang C, Shi J, Hu Y. Barriers and enabling factors in weight management of patients with nonalcoholic fatty liver disease: A qualitative study using the COM-B model of behaviour. Health Expect. 2023 Feb;26(1):355-365. doi: 10.1111/hex.13665. Epub 2022 Nov 16.
PubMed 36385729Kanwal F, Shubrook JH, Younossi Z, Natarajan Y, Bugianesi E, Rinella ME, Harrison SA, Mantzoros C, Pfotenhauer K, Klein S, Eckel RH, Kruger D, El-Serag H, Cusi K. Preparing for the NASH Epidemic: A Call to Action. Gastroenterology. 2021 Sep;161(3):1030-1042.e8. doi: 10.1053/j.gastro.2021.04.074. Epub 2021 Jul 26.
PubMed 34416976Kanwal F, Shubrook JH, Adams LA, Pfotenhauer K, Wai-Sun Wong V, Wright E, Abdelmalek MF, Harrison SA, Loomba R, Mantzoros CS, Bugianesi E, Eckel RH, Kaplan LM, El-Serag HB, Cusi K. Clinical Care Pathway for the Risk Stratification and Management of Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2021 Nov;161(5):1657-1669. doi: 10.1053/j.gastro.2021.07.049. Epub 2021 Sep 20.
PubMed 34602251Konerman MA, Walden P, Joseph M, Jackson EA, Lok AS, Rubenfire M. Impact of a structured lifestyle programme on patients with metabolic syndrome complicated by non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2019 Feb;49(3):296-307. doi: 10.1111/apt.15063. Epub 2018 Dec 18.
PubMed 30561027Ng CH, Lim WH, Chin YH, Yong JN, Zeng RW, Chan KE, Tan DJH, Fu CE, Tang ASP, Goh LH, Devi K, Chew NWS, Mak LL, Tamaki N, Huang DQ, Noureddin M, Siddiqui MS, Loomba R, Sanyal AJ, Muthiah M. Living in the non-alcoholic fatty liver disease silent epidemic: a qualitative systematic review of patients' perspectives. Aliment Pharmacol Ther. 2022 Aug;56(4):570-579. doi: 10.1111/apt.17121. Epub 2022 Jul 6.
PubMed 35791632Scott PJ. Occupational therapy services to enable liver patients to thrive following transplantation. Occup Ther Health Care. 2011 Oct;25(4):240-56. doi: 10.3109/07380577.2011.600427. Epub 2011 Aug 9.
PubMed 23899078
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06121999
- Acronym / sponsor ID
- 23-278-H
- Conditions
- Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD), Metabolic Associated-dysfunction Steatohepatitis (MASH)
- Keywords
- weight loss, lifestyle modification, behavior change, liver disease, physical activity, nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), noncommunicable disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Grand Valley State UniversityUniversity, hospital or other
- Collaborators
- Gastroenterology Associates of Western Michigan
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How do the two interventions compare for improving weight loss, health-related quality of life (HRQOL), and FibroScan results.
- 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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to the control or experimental intervention on a rolling basis.
| Arm | Type | Receives |
|---|---|---|
| Acceptance-based behavioral weight loss program (ABWL) | Active comparator | Behavioral: Standard of care acceptance-based behavioral weight loss programParticipants 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. |
| Occupational Therapy behavioral lifestyle intervention | Experimental | Behavioral: Standard of care acceptance-based behavioral weight loss program, Behavioral: Occupational therapy dietary and lifestyle modificationsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care acceptance-based behavioral weight loss programEvidence-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. | Behavioural | Acceptance-based behavioral weight loss program (ABWL), Occupational Therapy behavioral lifestyle intervention |
| Occupational therapy dietary and lifestyle modificationsOccupational 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. | Behavioural | Occupational Therapy behavioral lifestyle intervention |
Primary outcome
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.
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 25445199Forman 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.
- Background: PubMed 37534947Balakrishnan 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.
- Background: PubMed 37695493Keating 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 Dec;53(12):2347-2371. doi: 10.1007/s40279-023-01918-w. Epub 2023 Sep 11.
- Background: PubMed 31104046Park 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.
- Background: PubMed 31014080Edgelow 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.
- Background: PubMed 36115674Nielsen 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.
- Background: PubMed 29938529Meidert 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.
- Background: PubMed 36132088Mobasheri 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.
- Background: PubMed 28211165Younossi 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.
- Results publication: PubMed 36385729Gu Y, Zhou R, Kong T, Zhang W, Chen Y, Wang C, Shi J, Hu Y. Barriers and enabling factors in weight management of patients with nonalcoholic fatty liver disease: A qualitative study using the COM-B model of behaviour. Health Expect. 2023 Feb;26(1):355-365. doi: 10.1111/hex.13665. Epub 2022 Nov 16.
- Results publication: PubMed 34416976Kanwal F, Shubrook JH, Younossi Z, Natarajan Y, Bugianesi E, Rinella ME, Harrison SA, Mantzoros C, Pfotenhauer K, Klein S, Eckel RH, Kruger D, El-Serag H, Cusi K. Preparing for the NASH Epidemic: A Call to Action. Gastroenterology. 2021 Sep;161(3):1030-1042.e8. doi: 10.1053/j.gastro.2021.04.074. Epub 2021 Jul 26.
- Results publication: PubMed 34602251Kanwal F, Shubrook JH, Adams LA, Pfotenhauer K, Wai-Sun Wong V, Wright E, Abdelmalek MF, Harrison SA, Loomba R, Mantzoros CS, Bugianesi E, Eckel RH, Kaplan LM, El-Serag HB, Cusi K. Clinical Care Pathway for the Risk Stratification and Management of Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2021 Nov;161(5):1657-1669. doi: 10.1053/j.gastro.2021.07.049. Epub 2021 Sep 20.
- Individual participant dataSharing planned: No. Individual participant identification information will be de-identified. The de-identified data will be shared.
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Effect of Ancestry Supplementation in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
MASLD
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Truskowski, PhD principal investigator
Grand Valley State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational therapy dietary and lifestyle modifications in people with Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD) and Metabolic Associated-dysfunction Steatohepatitis (MASH), run by Grand Valley State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean % of total body weight loss (%TBWL) (time frame: End of study, week 13). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06121999, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.