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

NCT07111026 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

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

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH
  • Emory University

    lead OTHER

Principal Investigators

  • Erin Ferranti, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07111026 on ClinicalTrials.gov