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Corazones Unidos Study

NCT ID: NCT07298213

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-18

Study Completion Date

2026-07-17

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Your Heart, Your Health

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Your Heart, Your Health

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UA Collaboratory for Metabolic Disease Prevention & Treatment

Tucson, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Adriana Maldonado Assistant Professor, PhD

Role: CONTACT

Phone: 5206267279

Email: [email protected]

Edgar Villavicencio A Research Coordinator, MPH

Role: CONTACT

Phone: 5206264745

Email: [email protected]

Facility Contacts

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Adriana Maldonado Assistant Professor, PhD

Role: primary

Other Identifiers

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STUDY00006222

Identifier Type: -

Identifier Source: org_study_id