Recruiting

CVD Awareness Intervention

Sponsor:

University of Arizona

Code:

NCT07298213

Conditions

CVD - Cardiovascular Disease

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Your Heart, Your Health

Study Details

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

CVD - Cardiovascular Disease

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Study ID

NCT07298213

Start date

Jul 18, 2025

Status verified date

Jun, 2025

Completion date

Jul 17, 2026

Anticipated

Primary completion date

Jul 17, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Cardiovascular Health [ Time Frame: Baseline, 12 weeks, and 24 weeks ]

Central Contacts and Locations

Central contacts

Adriana Maldonado Assistant Professor, PhD

5206267279adrianamaldonado@arizona.edu

Edgar Villavicencio A Research Coordinator, MPH

5206264745evillavicencio@arizona.edu

Locations

UA Collaboratory for Metabolic Disease Prevention & Treatment

Recruiting

Tucson, Arizona, United States, 85714

Contacts

Adriana Maldonado Assistant Professor, PhD

5206264641adrianamaldonado@arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

Dec 23, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2025-12-23.