Developing and Testing a Multilevel, Culturally Appropriate Lifestyle Intervention For Hispanic Patients with Metabolic-dysfunction Associated Steatotic Liver Disease - PROJECT SUMMARY/ABSTRACT Metabolic-dysfunction associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease, is now one of the main risk factors for adverse liver outcomes, and Hispanic/Latino adults have the highest prevalence of MASLD compared to all other major racial/ethnic groups. Modifying diet and physical activity to achieve clinically significant weight loss (≥5%) is the only current treatment for MASLD. There is an urgent need to develop a culturally appropriate, multilevel, multidomain behavioral lifestyle intervention that provides disease-specific education and support and that also addresses the upstream influences on lifestyle behavior change in Hispanic/Latino patients with MASLD. The purpose of this K01 award is to prepare Dr. Natalia Heredia with the training and experience necessary to achieve her career goal of becoming an independent investigator focused on designing and implementing multilevel interventions to prevent and treat lifestyle-related conditions in Hispanic/Latino populations. Through both career development activities and the mentored research project, the proposed development plan is intended to ensure Dr. Heredia receives training in 1) multilevel lifestyle intervention development and implementation; 2) dissemination and implementation (D&I) research methods, including the adaptation of evidence-based interventions, and the use of mixed- methods research and hybrid-effectiveness designs; 3) liver disease diagnosis and management; and 4) statistical methods for testing multilevel lifestyle interventions. Dr. Heredia's mentoring team is composed of experts in lifestyle behaviors and interventions (Dr. Lorna McNeill, co-primary mentor), D&I research and Hispanic/Latino health (Dr. Maria Fernandez, co-primary mentor), liver disease (Dr. Jessica Hwang, co- mentor), and statistical methods for testing interventions (Dr. MinJae Lee, co-mentor). With guidance from her mentors, Dr. Heredia will adapt and pilot test a culturally appropriate multilevel, multidomain behavioral lifestyle intervention to achieve important changes in physical activity and diet, promote weight loss, and improve liver- related outcomes for Hispanic/Latino patients with MASLD. The study aims are to 1) adapt an individual-level lifestyle intervention for Hispanic/Latino patients with MASLD such that it addresses multiple levels and domains of influence, emphasizing the role of family members, healthcare providers, and access to social services, 2) using an explanatory sequential mixed-methods design, conduct a quasi-experimental pilot study of the multilevel intervention to assess feasibility and preliminary effectiveness, and 3) explore patient, family, and provider experiences in the pilot study to explain findings and refine the multilevel, multidomain intervention. Completion of the study will result in a finalized multilevel lifestyle intervention to support an R01 application for a full-scale trial evaluating the implementation and effectiveness of the intervention. Completion of the proposed research and training aims will provide Dr. Heredia with the skills and experience necessary to launch a successful career as an independent investigator focused on minority health and health disparities.
