Corazones Unidos Study

University of Arizona

Status: Enrolling

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

Treatments: Behavioral: Your Heart, Your Health

Study type: Interventional

Funder types: Other

Identifiers

NCT07298213

STUDY00006222

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Corazones Unidos

Experimental group

Description:

"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.

Treatment:

Behavioral: Your Heart, Your Health

Su Corazon, Su Vida

Active Comparator group

Description:

"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.

Treatment:

Behavioral: Your Heart, Your Health