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

NCT06121999 | Completed

• 1 other identifier: 23-278-H
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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:

1. 1.How do the two interventions compare for improving weight loss, health-related quality of life (HRQOL), and FibroScan results.
2. 2.Examine the role of occupational therapy on a multidisciplinary team for the treatment of MASLD and MASH.

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; chronic disease; obesity

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  End of study, week 13

Secondary Outcomes (2)

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

  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

  Baseline, week 1 compared to end of study, week 13

Study Arms (2)

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.

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.

Behavioral: Standard of care acceptance-based behavioral weight loss program; Behavioral: Occupational therapy dietary and lifestyle modifications

Interventions

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.

Acceptance-based behavioral weight loss program (ABWL); Occupational Therapy behavioral lifestyle intervention

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.

Occupational Therapy behavioral lifestyle intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Grand Valley State University: lead
• Gastroenterology Associates of Western Michigan: collaborator

Study Sites (1)

Gastroenterology Associates of Western Michigan, PLC

Wyoming, Michigan, 49519, United States

Location

Related Publications (43)

• 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.

  PMID: 25445199 BACKGROUND

• Gu 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.

  PMID: 36385729 BACKGROUND

• Kanwal 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.

  PMID: 34416976 BACKGROUND

• Kanwal 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.

  PMID: 34602251 BACKGROUND

• Konerman 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.

  PMID: 30561027 BACKGROUND

• Ng 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.

  PMID: 35791632 BACKGROUND

• Scott 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.

  PMID: 23899078 BACKGROUND

• Scott PJ, Brown VL. Resumption of valued activities in the first year post liver transplant. Occup Ther Health Care. 2012 Jan;26(1):48-63. doi: 10.3109/07380577.2011.643856.

  PMID: 23899107 BACKGROUND

• Arshad T, Henry L, Younossi ZM. Validation of the chronic liver disease questionnaire for non-alcoholic steatohepatitis in patients: impact for the clinic. Expert Rev Gastroenterol Hepatol. 2019 Aug;13(8):709-710. doi: 10.1080/17474124.2019.1636646. Epub 2019 Jun 28. No abstract available.

  PMID: 31248299 BACKGROUND

• Bahadir Agce Z, Ekici G. Person-centred, occupation-based intervention program supported with problem-solving therapy for type 2 diabetes: a randomized controlled trial. Health Qual Life Outcomes. 2020 Aug 3;18(1):265. doi: 10.1186/s12955-020-01521-x.

  PMID: 32746841 BACKGROUND

• Younossi ZM, Corey KE, Lim JK. AGA Clinical Practice Update on Lifestyle Modification Using Diet and Exercise to Achieve Weight Loss in the Management of Nonalcoholic Fatty Liver Disease: Expert Review. Gastroenterology. 2021 Feb;160(3):912-918. doi: 10.1053/j.gastro.2020.11.051. Epub 2020 Dec 9.

  PMID: 33307021 BACKGROUND

• Younossi ZM, Stepanova M, Younossi I, Racila A. Validation of Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis in Patients With Biopsy-Proven Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2093-2100.e3. doi: 10.1016/j.cgh.2019.01.001. Epub 2019 Jan 11.

  PMID: 30639779 BACKGROUND

• Scott PJ, McKinney KG, Perron JM, Ruff EG, Smiley JL. The Revised Role Checklist: Improved Utility, Feasibility, and Reliability. OTJR (Thorofare N J). 2019 Jan;39(1):56-63. doi: 10.1177/1539449218780618. Epub 2018 Jun 20.

  PMID: 29923446 BACKGROUND

• Occupational Therapy Practice Framework: Domain and Process-Fourth Edition. Am J Occup Ther. 2020 Aug 1;74(Supplement_2):7412410010p1-7412410010p87. doi: 10.5014/ajot.2020.74S2001.

  PMID: 34780625 BACKGROUND

• Bischoff M, Zimny S, Feiner S, Sauter J, Sydor S, Denk G, Nagel JM, Bischoff G, Rust C, Hohenester S. Multidisciplinary lifestyle intervention is associated with improvements in liver damage and in surrogate scores of NAFLD and liver fibrosis in morbidly obese patients. Eur J Nutr. 2022 Aug;61(5):2725-2735. doi: 10.1007/s00394-022-02846-7. Epub 2022 Mar 11.

  PMID: 35277756 BACKGROUND

• Buzzetti E, Linden A, Best LM, Madden AM, Roberts D, Chase TJG, Freeman SC, Cooper NJ, Sutton AJ, Fritche D, Milne EJ, Wright K, Pavlov CS, Davidson BR, Tsochatzis E, Gurusamy KS. Lifestyle modifications for nonalcohol-related fatty liver disease: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 11;6(6):CD013156. doi: 10.1002/14651858.CD013156.pub2.

  PMID: 34114650 BACKGROUND

• Chan WK, Chuah KH, Rajaram RB, Lim LL, Ratnasingam J, Vethakkan SR. Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A State-of-the-Art Review. J Obes Metab Syndr. 2023 Sep 30;32(3):197-213. doi: 10.7570/jomes23052. Epub 2023 Sep 13.

  PMID: 37700494 BACKGROUND

• Chai XN, Zhou BQ, Ning N, Pan T, Xu F, He SH, Chen NN, Sun M. Effects of lifestyle intervention on adults with metabolic associated fatty liver disease: A systematic review and meta-analysis. Front Endocrinol (Lausanne). 2023 Feb 16;14:1081096. doi: 10.3389/fendo.2023.1081096. eCollection 2023.

  PMID: 36875459 BACKGROUND

• Cook NS, Nagar SH, Jain A, Balp MM, Maylander M, Weiss O, Chatterjee S. Understanding Patient Preferences and Unmet Needs in Non-alcoholic Steatohepatitis (NASH): Insights from a Qualitative Online Bulletin Board Study. Adv Ther. 2019 Feb;36(2):478-491. doi: 10.1007/s12325-018-0856-0. Epub 2018 Dec 13.

  PMID: 30547371 BACKGROUND

• Dhaliwal HS, Singh R, Abraham AM, Sharma R, Goyal NK, Soloman R, Bansal P, Goyal A. Perception of Illness and Its Association with Treatment Willingness in Patients with Newly Diagnosed Nonalcoholic Fatty Liver Disease. Dig Dis Sci. 2021 Dec;66(12):4197-4207. doi: 10.1007/s10620-020-06794-2. Epub 2021 Jan 6.

  PMID: 33409801 BACKGROUND

• Fields B, Smallfield S. Occupational Therapy Practice Guidelines for Adults With Chronic Conditions. Am J Occup Ther. 2022 Mar 1;76(2):7602397010. doi: 10.5014/ajot.2022/762001.

  PMID: 35311934 BACKGROUND

• Glass L, Asefa H, Volk M, Lok AS, Tincopa MA. Disease Knowledge, Health-Related Quality of Life, and Lifestyle Behavior Change in Patients with Nonalcoholic Fatty Liver Disease: Impact of an Educational Intervention. Dig Dis Sci. 2022 Jun;67(6):2123-2133. doi: 10.1007/s10620-021-07052-9. Epub 2021 May 27.

  PMID: 34043121 BACKGROUND

• Glass O, Liu D, Bechard E, Guy CD, Pendergast J, Mae Diehl A, Abdelmalek MF. Perceptions of Exercise and Its Challenges in Patients With Nonalcoholic Fatty Liver Disease: A Survey-Based Study. Hepatol Commun. 2022 Feb;6(2):334-344. doi: 10.1002/hep4.1808. Epub 2021 Oct 26.

  PMID: 34697917 BACKGROUND

• Heredia NI, Gaba R, Liu Y, Jain S, Rungta M, Rungta M, El-Serag HB, Kanwal F, Thrift AP, Balakrishnan M. Perceptions of weight status and energy balance behaviors among patients with non-alcoholic fatty liver disease. Sci Rep. 2022 Apr 5;12(1):5695. doi: 10.1038/s41598-022-09583-1.

  PMID: 35383229 BACKGROUND

• Hershman M, Torbjornsen K, Pang D, Wyatt B, Dieterich DT, Perumalswami PV, Branch AD, Dinani AM. Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study. Obes Sci Pract. 2022 Oct 20;9(3):218-225. doi: 10.1002/osp4.637. eCollection 2023 Jun.

  PMID: 37287520 BACKGROUND

• 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.

  PMID: 37534947 BACKGROUND

• 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 Dec;53(12):2347-2371. doi: 10.1007/s40279-023-01918-w. Epub 2023 Sep 11.

  PMID: 37695493 BACKGROUND

• 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.

  PMID: 31104046 BACKGROUND

• Ho ECM, Siu AMH. Occupational Therapy Practice in Sleep Management: A Review of Conceptual Models and Research Evidence. Occup Ther Int. 2018 Jul 29;2018:8637498. doi: 10.1155/2018/8637498. eCollection 2018.

  PMID: 30150906 BACKGROUND

• Mack RA, Stanton CE, Carney MR. The importance of including occupational therapists as part of the multidisciplinary team in the management of eating disorders: a narrative review incorporating lived experience. J Eat Disord. 2023 Mar 9;11(1):37. doi: 10.1186/s40337-023-00763-6.

  PMID: 36894981 BACKGROUND

• 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.

  PMID: 31014080 BACKGROUND

• Goodman V, Wardrope B, Myers S, Cohen S, McCorquodale L, Kinsella EA. Mindfulness and human occupation: A scoping review. Scand J Occup Ther. 2019 Apr;26(3):157-170. doi: 10.1080/11038128.2018.1483422. Epub 2018 Jun 28.

  PMID: 29952233 BACKGROUND

• 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.

  PMID: 36115674 BACKGROUND

• 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.

  PMID: 29938529 BACKGROUND

• 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.

  PMID: 36132088 BACKGROUND

• Rinella ME, Neuschwander-Tetri BA, Siddiqui MS, Abdelmalek MF, Caldwell S, Barb D, Kleiner DE, Loomba R. AASLD Practice Guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Hepatology. 2023 May 1;77(5):1797-1835. doi: 10.1097/HEP.0000000000000323. Epub 2023 Mar 17. No abstract available.

  PMID: 36727674 BACKGROUND

• Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gomez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. Hepatology. 2023 Dec 1;78(6):1966-1986. doi: 10.1097/HEP.0000000000000520. Epub 2023 Jun 24.

  PMID: 37363821 BACKGROUND

• Romero-Gomez M, Zelber-Sagi S, Trenell M. Treatment of NAFLD with diet, physical activity and exercise. J Hepatol. 2017 Oct;67(4):829-846. doi: 10.1016/j.jhep.2017.05.016. Epub 2017 May 23.

  PMID: 28545937 BACKGROUND

• Smallfield S, Fang L, Kyler D. Self-Management Interventions to Improve Activities of Daily Living and Rest and Sleep for Adults With Chronic Conditions: A Systematic Review. Am J Occup Ther. 2021 Jul 1;75(4):7504190010. doi: 10.5014/ajot.2021.046946.

  PMID: 34780611 BACKGROUND

• Tomah S, Salah T, Al-Badri M, Dhaver S, Gardner H, Tasabehji MW, Hamdy O. Multidisciplinary intensive lifestyle intervention improves markers of nonalcoholic fatty liver disease (NAFLD) in patients with type 1 diabetes and obesity: a retrospective matched-cohort study. Clin Diabetes Endocrinol. 2023 Apr 12;9(1):3. doi: 10.1186/s40842-023-00150-9.

  PMID: 37046323 BACKGROUND

• Wang L, Zhou H, Liu Y, Wang X, Yan W, Zhang J, Ren H. Factors influencing adherence to lifestyle prescriptions among patients with nonalcoholic fatty liver disease: A qualitative study using the health action process approach framework. Front Public Health. 2023 Mar 17;11:1131827. doi: 10.3389/fpubh.2023.1131827. eCollection 2023.

  PMID: 37006574 BACKGROUND

• Younossi ZM, Zelber-Sagi S, Henry L, Gerber LH. Lifestyle interventions in nonalcoholic fatty liver disease. Nat Rev Gastroenterol Hepatol. 2023 Nov;20(11):708-722. doi: 10.1038/s41575-023-00800-4. Epub 2023 Jul 4.

  PMID: 37402873 BACKGROUND

• 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.

  PMID: 28211165 BACKGROUND

MeSH Terms

Conditions

Weight Loss; Liver Diseases; Motor Activity; Non-alcoholic Fatty Liver Disease; Noncommunicable Diseases; Chronic Disease; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Diseases; Behavior; Fatty Liver; Disease Attributes; Pathologic Processes; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Scott Truskowski, PhD

  Grand Valley State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OST Department Chair, Associate Professor Occupational Science and Therapy Department

Model Details: Participants will be randomly assigned to the control or experimental intervention on a rolling basis.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: November 8, 2023
• Study Start: August 17, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)