Corazones Unidos Study

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT07298213
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 18, 2025
Status verified
Jun 2025
Primary completion
Jul 17, 2026
Completion
Jul 17, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UA Collaboratory for Metabolic Disease Prevention & TreatmentTucsonArizona85714
Adriana Maldonado Assistant Professor, PhD
[email protected]
5206264641

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By research site
UA Collaboratory for Metabolic Disease Prevention & Treatment· Tucson, AZ

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