Community Health Intervention for Fatty Liver and Heart Diseases
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help Mexican-origin adults with a specific liver condition, known as MASLD, improve their heart health. Researchers want to determine if a program called "Your Heart, Your Health," led by community health workers, can boost awareness about heart risks and encourage healthier lifestyles. The trial includes two groups: one with peer support and another without. It seeks participants with MASLD who can bring a family member or close friend to join them in the sessions. Those diagnosed with MASLD and having someone in their social circle willing to participate might be a good fit.
As an unphased trial, this study offers a unique opportunity to contribute to valuable research that could enhance heart health awareness and lifestyle changes in the community.
Will I have to stop taking my current medications?
If you are taking any anti-inflammatory or liver-damaging medications regularly, or medications for psychiatric disorders, you will not be able to participate in the trial. The protocol does not specify if you need to stop other medications, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that community health workers lead the "Corazones Unidos" program to improve heart and liver health. The program is safe, emphasizing education and support to encourage lifestyle changes without drugs or medical procedures. This approach typically makes it safer and easier for participants to manage.
Reports have not indicated negative effects from this type of program, as it centers on sharing information and promoting healthier habits. This method has been used elsewhere and is generally considered safe due to its reliance on support and education.
For those considering joining a trial for this program, the focus is on learning and making healthier lifestyle choices, which usually involves minimal risk.12345Why are researchers excited about this trial?
Researchers are excited about the "Your Heart, Your Health" treatments because they focus on community engagement to address fatty liver and heart diseases, which is different from current standard care options like medication and lifestyle changes. The "Corazones Unidos" program uniquely combines social support with health education by delivering sessions to pairs of participants, fostering a supportive environment. Meanwhile, the "Su Corazon, Su Vida" program adapts existing health curricula for community settings, making it more accessible and potentially more effective without peer support. These approaches aim to harness the power of community and personalized support to improve health outcomes.
What evidence suggests that this trial's treatments could be effective for CVD and MASLD?
Research has shown that oxidative stress, an imbalance between harmful and protective molecules in the body, plays a key role in high blood pressure and heart disease. This is significant because one treatment in this trial, "Corazones Unidos," aims to address these issues. By targeting oxidative stress, it might improve heart health and help manage conditions like Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The focus on lifestyle changes and community support could help participants reduce their risk of heart problems. Although specific study data on "Corazones Unidos" is limited, the approach is based on addressing known risk factors.678910
Are You a Good Fit for This Trial?
The Corazones Unidos Study is for Mexican-origin adults in Southern Arizona with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), which can lead to liver cancer and increases the risk of cardiovascular disease. Participants should be interested in a community health worker-led program focusing on heart health awareness and lifestyle changes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the 'Corazones Unidos' intervention over 12 weekly in-person sessions
Follow-up
Participants are monitored for cardiovascular health outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Your Heart, Your Health
Trial Overview
This study tests the 'Your Heart, Your Health' intervention, where community health workers guide participants to understand their cardiovascular risks better and encourage healthy lifestyle adjustments. The goal is to see if this approach is acceptable and workable within this specific community.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
"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.
"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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arizona
Lead Sponsor
Citations
1.
frontiersin.org
frontiersin.org/journals/molecular-biosciences/articles/10.3389/fmolb.2025.1611842/fullLinking oxidative stress biomarkers to disease progression ...
3Clínica “Corazones Unidos”, Santo Domingo, Dominican Republic. Oxidative stress (OS) is increasingly recognized as a key factor linking hypertension (HTN) ...
Social determinants in the access to health care for Chagas ...
... Corazones Unidos por el Chagas from Cochabamba. The aim of this study is to explore the social determinants in the living realities of those ...
Genetic Linkage of Serum Homocysteine in Dominican ...
We also thank Dr Luis Cuello Mainardi, Director of the Clinicas Corazones Unidos, where subjects were enrolled in the DR. Sources of Funding.
4.
researchgate.net
researchgate.net/publication/392098598_Linking_oxidative_stress_biomarkers_to_disease_progression_and_antioxidant_therapy_in_hypertension_and_diabetes_mellitusLinking oxidative stress biomarkers to disease progression ...
... Corazones Unidos”, Santo Domingo, Dominican Republic. Oxidative stress (OS) is increasingly recognized as a key factor linking. hypertension ...
Cardiac Nursing CEU - Free CEU Courses Online For Nurses
Corazones Unidos Study. December 23, 2025. Conditions: CVD - Cardiovascular Disease; MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Study Details | NCT07298213 | Corazones Unidos Study
Thus, the purpose of this study is to examine the acceptability and feasibility of a community health worker (CHW)-led intervention aimed to ...
7.
trial.medpath.com
trial.medpath.com/clinical-trial/996a8ca3606831d4/nct07298213-su-corazon-su-vida-mexican-adults-masldCorazones Unidos Study | MedPath
Corazones Unidos Study ... CVD is the leading cause of death among individuals with MASLD, a risk factor for liver cancer. In Southern Arizona, ...
Cardiovascular Risk in Fatty Liver Disease - PubMed Central
The current literature supports the increasing evidence associating FLD with several cardiovascular (CV) adverse events including coronary artery disease.
9.
ecrjournal.com
ecrjournal.com/articles/management-cardiovascular-risk-non-alcoholic-fatty-liver-disease-setting?language_content_entity=enCardiovascular Risk in NAFLD | ECR Journal
NAFLD is an underappreciated and independent risk factor for atherosclerotic cardiovascular disease, which is the principal cause of death in patients with ...
10.
professional.heart.org
professional.heart.org/en/science-news/nonalcoholic-fatty-liver-disease-and-cardiovascular-riskNonalcoholic Fatty Liver Disease and Cardiovascular Risk
This scientific statement reviews the underlying risk factors and pathophysiology of NAFLD, the associations with atherosclerotic cardiovascular ...
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