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

NCT07111026 | Recruiting DMC

• 2 other identifiers: STUDY000084871R01NR021664-01
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

occupational stress; gender related stress; social isolation; psychological stress; cardiometabolic health; social determinants of health

Outcome Measures

Primary Outcomes (9)

• Change in cardiometabolic health

  The AHA's Life's Essential 8 score will be used to assess cardiometabolic health. The 8 components include 4 health behaviors (self-report) and 4 health factors (objective data). Each component is assigned 0-100 points per AHA LE8 scoring instructions. The total score is calculated as the mean of the 8 scores; higher total LE8 scores indicate greater adherence to health-promoting behaviors and factors.

  T-0 (Baseline) ,T2 (3 months), T3 (6 months), T4 (7-9 months)

• Change in diet

  Diet will be assessed with the 23-item Mediterranean Eating Pattern for Americans (MEPA) III Questionnaire, adapted from the Mediterranean Diet Adherence Scale. MEPA assesses accordance with the Mediterranean-like diet pattern and asks about consumption of vegetables, nuts and seeds, fruits, fats and oils, meat and fish, dairy, beans and grains, desserts and fast food, and beverages Higher scores reflect greater adherence.

  Baseline, End of study (3 months)

• Change in physical activity

  Physical activity will be assessed with the 27-item International Physical Activity Questionnaire (IPAQ), a seven-day physical activity recall used in several large-scale studies and validated for use with Spanish-speaking communities in the US. A composite measure of physical activity will be derived based on the number of moderate to vigorous physical activity \[5-8 metabolic equivalents (METs)\] events the participant had in a typical week

  Baseline, End of study (3 months)

• Change in nicotine consumption

  Nicotine will be assessed in the health history survey. Questions include the history of current or ever smoked, the number of cigarettes smoked per day, and whether they live with an active smoker

  Baseline, End of study (3 months)

• Change in Sleep

  Sleep will be assessed with the Pittsburgh Sleep Quality Index (PSQI), a validated scale consisting of 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction. Each component is scored from 0 to 3, with higher scores indicating poorer sleep quality. The global PSQI score ranges from 0 to 21, and a score greater than 5 typically indicates poor sleep quality.

  Baseline, End of study (3 months)

• Change in Body Mass Index (BMI)

  Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared from measured height and weight. Measurements of height to the nearest 0.1 cm using A SECA 213 portable stadiometer and weight to the nearest 0.1 kg using a SECA 813 high-capacity weight scale will be conducted in duplicate.

  Baseline, End of study (3 months)

• Change in Lipids (non-HDL cholesterol)

  Change in lipid levels throughout the study.

  Baseline, End of study (3 months)

• Change in HbA1c

  Change in the HbA1c levels during the study will be reported

  Baseline, End of study ( 3 months)

• Change in Blood pressure

  Blood pressure (BP) (resting) will be measured three times with a CARESCAPE V100 blood pressure monitor after the participant is seated for five minutes. The average of the last two BP measurements will be used to calculate the mean systolic and diastolic BP.

  Baseline, Emd of study (3 months)

Secondary Outcomes (11)

• Social Isolation

  Baseline, End of study (3 months)

• Participant Satisfaction

  T1 (1.2 months) ,T2 (3 months), T3 (6 months), T4 (7-9 months)

• Instrumental support

  Baselien, End of study (3 months)

• Companionship support

  Baseline, End of study (3 months)

• Informational Support SF 8a

  Baseline, End of study (3 months)

Study Arms (2)

Sisters of Heart

EXPERIMENTAL

Behavioral: Sisters of Heart

Basic group

OTHER

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

Behavioral: Basic intervention

Interventions

Sisters of Heart 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.

Also known as: Hermanas de Corazon

Sisters of Heart

Basic intervention 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

Basic group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Southern GA - Colquitt County

Ellenton, Georgia, 31747, United States

RECRUITING

MeSH Terms

Conditions

Occupational Stress; Social Isolation; Hypertension; Glucose Intolerance; Diabetes Mellitus; Obesity; Stress, Psychological

Condition Hierarchy (Ancestors)

Occupational Diseases; Behavioral Symptoms; Behavior; Social Behavior; Vascular Diseases; Cardiovascular Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erin Ferranti, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Ferranti, PhD

CONTACT

404-712-9551; epoe@emory.edu

Ursula Kelly

CONTACT

404-727-2715; ukelly@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 8, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: De-identified data will be made available no later than the time of publication of primary results or at the end of the funding period, whichever occurs first. Data will remain available indefinitely in the Emory Dataverse for continued public access.
• Access Criteria: Data will be shared with qualified investigators who have an appropriate research question and an approved Data Use Agreement (DUA). Data may be used for secondary analyses consistent with the original informed consent and within the scope of social, behavioral, and clinical research related to cardiovascular health, social determinants of health, and intervention outcomes. Data will be shared through the Emory Dataverse repository. All datasets will be assigned Digital Object Identifiers (DOIs), accompanied by relevant documentation, and made available via secure access mechanisms defined by Emory Dataverse policy

Locations

US (1)