Corazones Unidos Study for Cardiovascular Health in Mexican-Origin Adults with MASLD

This study, called the Corazones Unidos Study, is looking at a program called "Your Heart, Your Health." This program uses trained community health workers (CHWs) to teach Mexican-origin adults with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) about heart-healthy behaviors, heart attack symptoms, and healthy eating. The goal is to see if this program can help increase awareness of heart disease risks and encourage lifestyle changes. Heart disease is a major health concern for Mexican-origin adults, especially those with MASLD. The study aims to enroll 45 participants and will measure changes in cardiovascular health at the start, after 12 weeks, and after 24 weeks.

Study design
This interventional study plans to enroll 45 participants. It is designed to examine the acceptability and feasibility of a community health worker-led intervention.
What's involved
Participants will take part in educational sessions led by trained community health workers. Cardiovascular health will be measured at the start, 12 weeks, and 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 weeks, with measurements taken at baseline, 12 weeks, and 24 weeks.

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NCT07298213

Corazones Unidos Study

Recruiting
NAAges 18+InterventionalPrevention
University of Arizona
~45 participants
Updated 2025-12-23 on ClinicalTrials.gov
What's tested:Your Heart, Your Health

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cardiovascular Health
Measured over Baseline, 12 weeks, and 24 weeks
CVD - Cardiovascular Disease
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
1 sites across 1 states
Arizona1
Adriana Maldonado Assistant Professor, PhD
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Eligibility criteria

Inclusion

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

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.
  • Cardiovascular HealthBaseline, 12 weeks, and 24 weeks

    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).