Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07298213

Pilot Test of Su Corazon Su Vida Among Mexican-Origin Adults With MASLD

Led by University of Arizona · Updated on 2025-12-23

45

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating a community health worker-led program designed to raise awareness of cardiovascular disease (CVD) risk and encourage lifestyle changes among Mexican-origin adults with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in Southern Arizona. This study aims to address the high rates of CVD and cancer deaths in this population by providing tailored strategies to manage risk factors and improve health equity for Hispanic communities and their caregivers. The study compares two groups: one receiving the "Corazones Unidos" intervention, which includes 12 weekly in-person sessions led by trained community health workers focusing on heart-healthy behaviors, symptom recognition, and behavioral change techniques; and the "Su Corazón, Su Vida" group, which receives a standard 12-week evidence-based curriculum without peer support. Both programs are delivered in community settings and include materials like videos, role play, and culturally appropriate brochures. Participants will attend sessions over 12 weeks and be assessed at baseline, 12 weeks, and 24 weeks for their cardiovascular health. The study involves collaboration between participants and their social network members to set and maintain lifestyle goals. Researchers will track adherence, measure health outcomes, and monitor safety throughout the study, which aims to improve management of CVD risk factors in this vulnerable group.

CONDITIONS

Brief Title

Corazones Unidos Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be of Mexican origin or Mexican descent
  • Be 18 years old or older
  • Have a confirmed diagnosis of MASLD (CAP score of 248 dB/m or higher)
  • Have an adult member of your social network interested in participating who lives within 25 miles of your residence
  • Be able to provide informed consent
  • Be able to speak, read, and write in English and/or Spanish
Not Eligible

You will not qualify if you...

  • Report ongoing or recent alcohol consumption exceeding 21 standard drinks per week for men or 14 for women
  • Have a previous diagnosis of liver cancer
  • Regularly take anti-inflammatory or hepatotoxic medications
  • Take medication for any psychiatric disorders
  • Have a diagnosis of depression
  • Have a diagnosis of autoimmune disorders
  • Be pregnant or breastfeeding
  • For social network participants, living more than 25 miles from the intervention participant's residence

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 12 weeks

Participants attend weekly 60-minute educational sessions focused on heart-healthy behaviors, behavioral change techniques, and support strategies. Sessions are delivered either as dyads with peer support or as a standard group curriculum without peer support.

12 weekly in-person visits

Follow-up

Duration - 12 weeks

Participants are monitored to assess cardiovascular health after completing the educational sessions.

2 visits (at 12 weeks and 24 weeks post-baseline)

Trial Site Locations

Total: 1 location

1

UA Collaboratory for Metabolic Disease Prevention & Treatment

Tucson, Arizona, United States, 85714

Actively Recruiting

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Research Team

A

Adriana Maldonado Assistant Professor, PhD

E

Edgar Villavicencio A Research Coordinator, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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