Corazones Unidos Study

NCT07298213 | Recruiting

• 1 other identifier: STUDY00006222
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; CVD - Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Corazones Unidos

EXPERIMENTAL

"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

Su Corazon, Su Vida

ACTIVE COMPARATOR

"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

Interventions

Your Heart, Your Health BEHAVIORAL

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.

Corazones Unidos; Su Corazon, Su Vida

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

UA Collaboratory for Metabolic Disease Prevention & Treatment

Tucson, Arizona, 85714, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Adriana Maldonado Assistant Professor, PhD

CONTACT

5206267279; adrianamaldonado@arizona.edu

Edgar Villavicencio A Research Coordinator, MPH

CONTACT

5206264745; evillavicencio@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 23, 2025
• Study Start: July 18, 2025
• Primary Completion (Estimated): July 17, 2026
• Study Completion (Estimated): July 17, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)