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

NCT ID: NCT07111026

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-16
• Study Completion Date: 2028-12-31

Brief Summary

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.

Detailed 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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Sisters of Heart

Group Type: EXPERIMENTAL

Sisters of Heart

Intervention Type: BEHAVIORAL

The intervention consists of ten weekly, 60-75-minute in-person peer support group sessions led by trained community health workers/promotoras (CHWs/Ps), with 6-10 participants per group. Sessions will be semi-structured, covering AHA Life's Essential 8 (LE8), stress management, and individualized topics based on participant priorities and social needs identified through surveys or group discussions. Each session includes stress management, core educational content, and time for addressing participant-driven issues. CHWs/Ps will also provide individualized support outside the sessions through direct community resource navigation, including phone or in-person "warm handoffs" to needed services.

Basic group

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

Group Type: OTHER

Basic intervention

Intervention Type: BEHAVIORAL

The Basic intervention will include assessment of AHA LE8, provision to participants of results of 1) their baseline AHA LE8 assessments, including lab results, 2) written/online information with pertinent AHA LE8 health education content, 3) stress management educational materials, and 4) written information about the Ellenton Migrant Farm Worker Clinic and a community resource list

Interventions

Sisters of Heart

The intervention consists of ten weekly, 60-75-minute in-person peer support group sessions led by trained community health workers/promotoras (CHWs/Ps), with 6-10 participants per group. Sessions will be semi-structured, covering AHA Life's Essential 8 (LE8), stress management, and individualized topics based on participant priorities and social needs identified through surveys or group discussions. Each session includes stress management, core educational content, and time for addressing participant-driven issues. CHWs/Ps will also provide individualized support outside the sessions through direct community resource navigation, including phone or in-person "warm handoffs" to needed services.

Intervention Type: BEHAVIORAL

Basic intervention

The Basic intervention will include assessment of AHA LE8, provision to participants of results of 1) their baseline AHA LE8 assessments, including lab results, 2) written/online information with pertinent AHA LE8 health education content, 3) stress management educational materials, and 4) written information about the Ellenton Migrant Farm Worker Clinic and a community resource list

Intervention Type: BEHAVIORAL

Other Intervention Names

Hermanas de Corazon

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Erin Ferranti

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erin Ferranti, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Southern GA - Colquitt County

Ellenton, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erin Ferranti, PhD

Role: CONTACT

epoe@emory.edu

404-712-9551

Ursula Kelly

Role: CONTACT

ukelly@emory.edu

404-727-2715

Facility Contacts

Bassey Enun

Role: primary

benun@emory.edu

Other Identifiers

1R01NR021664-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00008487

Identifier Type: -

Identifier Source: org_study_id