ClinicalTrials.Veeva

Menu

Sisters of Heart (Hermanas de Corazón): A Community Health Worker Initiative for Improving Heart Health in Migrant Farmworker Women

Emory University logo

Emory University

Status

Enrolling

Conditions

Hypertension
Diabetes
Occupational Stress
Gender Related Stress
Obesity
Pre Diabetes
Social Isolation

Treatments

Behavioral: Sisters of Heart
Behavioral: Basic intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT07111026
STUDY00008487
1R01NR021664-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this hybrid Type 1 effectiveness-implementation trial is to test the extent to which a peer support and community resource navigation intervention improves psychological well-being, addresses social determinants of health and thus reduces cardiometabolic risk among rural, migrant, low-income farmworker women aged 18-45 years. The main questions it aims to answer are:

  • If and to what extent does the intervention reduce stress, social isolation, and psychological distress by improving social support and access to needed resources?
  • If and to what extent does the intervention improve cardiometabolic health, measured by the American Heart Association's Life's Essential 8 (LE8) score?

Researchers will compare the CHW-led Sisters of Heart (Hermanas de Corazón) intervention to a Basic intervention (LE8 assessment and resource information) to assess the effect of peer support and community resource navigation on heart health outcomes.

Full description

Cardiovascular disease (CVD) is the leading cause of death in U.S. women, with a concerning rise in CVD mortality among women under 65-particularly those aged 35-44. Rural, migrant farmworker women face disproportionate risk factors and health disparities related to CVD, yet they remain underrecognized and underserved in prevention efforts. Only 44% of women recognize CVD as their top health threat. Although just 6% of Latinas have been diagnosed with CVD, they experience higher rates of obesity (48% vs. 38%) and type 2 diabetes (13% vs. 6%) compared to non-Latina White women.

Women farmworkers in rural areas face a compounded risk due to the convergence of biological, social, and structural factors. They are more likely to enter pregnancy with suboptimal cardiometabolic health and are at greater risk of gestational complications like preeclampsia and gestational diabetes, both of which significantly elevate future CVD risk. Cardiometabolic risks in the preconception and perinatal periods are strong predictors of both maternal mortality and lifelong CVD.

Improving cardiovascular health (CVH) in reproductive-age women is crucial to reducing maternal morbidity and long-term CVD burden. Many women's CVD risks go undiagnosed until pregnancy, underscoring the need for earlier prevention. The American Heart Association's Life's Essential 8 (LE8) provides a validated framework to measure and improve CVH. Yet, data show that only 1 in 5 U.S. Hispanic adults has high CVH, with Hispanic women scoring lower on diet, physical activity, and BMI metrics.

To address this, the study proposes a Community Health Worker (CHW)-led peer support intervention, Sisters of Heart (Hermanas de Corazón), targeting rural, low-income, reproductive-aged women farmworkers. While peer support interventions have demonstrated success in predominantly White, middle-aged populations and other health domains among underserved groups (e.g., cancer screening, postpartum wellness), no tailored CVD peer-support model currently exists for this high-risk population.

The Type 1 Hybrid Effectiveness-Implementation Design is ideally suited to this work. It allows for rigorous testing of the intervention's impact on CVH while simultaneously identifying barriers and facilitators to real-world implementation in rural farmworker settings. The study will fill an urgent gap by:

  • Tailoring a culturally and linguistically appropriate intervention to Latina farmworkers
  • Embedding trauma-informed care into CVD prevention
  • Addressing SDOH-related stress and unmet needs
  • Empowering CHWs to support peer behavior change and health system navigation
  • Laying the groundwork for scaling and sustaining community-based CVH strategies in an underserved setting

Enrollment

250 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • self-identified female employed as a migrant farmworker;
  • Fluent in Spanish or English verbal literacy
  • Planning to be in the geographic area for a minimum of 6 months.

Exclusion criteria

  • Cognitive or psychological impairment precluding informed consent and/or active participation in the study due to substance use, neurologic, or other disorder
  • Pregnant or breastfeeding.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

250 participants in 2 patient groups

Sisters of Heart
Experimental group
Treatment:
Behavioral: Sisters of Heart
Basic group
Other group
Description:
Participants randomized to the Basic Intervention will have the option of crossing over to Sisters of Heart (Hermanas de Corazón's) intervention after their 3-month data collection is completed
Treatment:
Behavioral: Basic intervention

Trial contacts and locations

1

Loading...

Central trial contact

Ursula Kelly; Erin Ferranti, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems