Corazones Unidos Study

Pilot Test of Su Corazon Su Vida Among Mexican Origin Adults With MASLD

CVD is the leading cause of death among individuals with MASLD, a risk factor for liver cancer. In Southern Arizona, CVD and cancer (including liver and gastric cancer) are among the leading causes of death for Mexican-origin adults.1 Given Mexican-origin adults' disproportionate burden of CVD-related mortality37 and higher rates of MASLD compared to other ethnic/racial groups; we urgently need to develop contextually tailored strategies for management of CVD risk factors and outcomes. Thus, the purpose of this study is to examine the acceptability and feasibility of a community health worker (CHW)-led intervention aimed to increase cardiovascular risk awareness and promote lifestyle modifications among Mexican-origin adults with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in the Southern Arizona region. The proposed project has the potential to improve health outcomes for this vulnerable population and contribute to the ACS-CHERC's overarching goal of improving health equity for Hispanic communities and family caregivers.

Study Overview

• Status: Recruiting
• Conditions: CVD - Cardiovascular Disease; MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
• Intervention / Treatment: Behavioral: Your Heart, Your Health

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adriana Maldonado Assistant Professor, PhD; Phone Number: 5206267279; Email: adrianamaldonado@arizona.edu
• Study Contact Backup: Name: Edgar Villavicencio A Research Coordinator, MPH; Phone Number: 5206264745; Email: evillavicencio@arizona.edu

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85714
      • Recruiting
      • UA Collaboratory for Metabolic Disease Prevention & Treatment
      • Contact: Adriana Maldonado Assistant Professor, PhD; Phone Number: 5206264641; Email: adrianamaldonado@arizona.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eligible intervention participants must (1) be Mexican-origin/Mexican decent, (2) be ≥ 18 years old, (3) have a confirmed MASLD diagnosis (CAP score of ≥ 248 dB/m); (4) have an adult member of their social network who might be interested in participating in the study and who lives within 25 miles of the participant's residence; (5) be able to provide informed consent; and (6) be able to speak, read, and write in English and/or Spanish. Eligible social support participants must (1) be ≥ 18 years old, (2) be first degree blood relative or spouse/significant other to the intervention participants, (3) be able to provide informed consent; and (4) be able to speak, read, and write in English and/or Spanish.

Exclusion Criteria:

• Exclusion for individuals interested in the intervention component of the study will be excluded if they report (1) ongoing or recent alcohol consumption (≥21 standard drinks on average per week in men and ≥14 standard drinks on average per week in women); (2) previous diagnosis of liver cancer; (3) taking any anti-inflammatory or hepatoxic medication regularly; (4) taking medication for any form of psychiatric disorders; (5) diagnosis of depression; (6) diagnosis of autoimmune disorders; or (7) women who are pregnant or breastfeeding due to hormonal changes. Exclusion for those interested to be part of the study as social network participants will not be considered for participation if they (1) live more than 25 miles of the intervention participant's residence.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Corazones Unidos; "Corazones Unidos" will be delivered over 12 weekly in-person 60-minute sessions to dyads (consisting on both, intervention and social network participants) in community-based settings.	Behavioral: Your Heart, Your Health; Trained CHWs will facilitate educational sessions where participants will learn about heart-healthy behaviors, heart attack symptoms, heart-healthy eating for Hispanic families, and risk factors for both CVD and MASLD. Participants will also be taught behavioral change techniques including goal setting, problem solving, and relapse prevention. Specifically, participants will be asked to collaborate in selecting specific lifestyle goals and to develop shared strategies for improving adherence to their goals, overcoming barriers, and providing support to address potential relapses. Curriculum content will be supplemented by a variety of approaches designed to motivate behavior change including videos, role play, and low-literacy culturally appropriate brochures published by NHLBI.
Active Comparator: Su Corazon, Su Vida; "Su Corazón, Su Vida" group will receive the standard 12-week evidence-based curriculum as a group in a community setting; however, with no peer support provided.	Behavioral: Your Heart, Your Health; Trained CHWs will facilitate educational sessions where participants will learn about heart-healthy behaviors, heart attack symptoms, heart-healthy eating for Hispanic families, and risk factors for both CVD and MASLD. Participants will also be taught behavioral change techniques including goal setting, problem solving, and relapse prevention. Specifically, participants will be asked to collaborate in selecting specific lifestyle goals and to develop shared strategies for improving adherence to their goals, overcoming barriers, and providing support to address potential relapses. Curriculum content will be supplemented by a variety of approaches designed to motivate behavior change including videos, role play, and low-literacy culturally appropriate brochures published by NHLBI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Health	A composite score modeled after the American Heart Association Life's Essential Eight will be computed. Independent scores for diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, and blood pressure will be calculated and then transformed into a graded score ranging from 0 (worst) to 100 (best).	Baseline, 12 weeks, and 24 weeks

Collaborators and Investigators

• Sponsor: University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2025
• Primary Completion (Estimated): July 17, 2026
• Study Completion (Estimated): July 17, 2026

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: STUDY00006222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No