Recruiting

Sisters of Heart

Sponsor:

Emory University

Code:

NCT07111026

Conditions

Occupational Stress

Gender Related Stress

Social Isolation

Hypertension

Pre Diabetes

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Sisters for Heart Health

Basic intervention

Study Details

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 non-biologic drivers of health (access to healthcare, supportive services, nutrition, housing stability, transportation, chronic stress, social support), and thus reduces cardiometabolic risk among rural, low-income farmworker women aged 18-50 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 for Heart Health 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

Study ID

NCT07111026

Start date

Sep 16, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Self-identified female employed as a 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.

Study Design

Enrollment

269 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Sisters for Heart Health

other: Basic group

Participants randomized to the Basic Intervention will have the option of crossing over to the Sisters for Heart Health intervention after their 3-month data collection is completed

Interventions

Sisters for Heart Health

The intervention consists of ten weekly, 60-75-minute in-person peer support group sessions led by trained community health workers (CHWs), 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 will also provide individualized support outside the sessions through direct community resource navigation, including phone or in-person "warm handoffs" to needed services.

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 Farm Worker Clinic and a community resource list

Primary outcome measure

  • Change in cardiometabolic health [ Time Frame: T-0 (Baseline) ,T2 (3 months), T3 (6 months), T4 (7-9 months) ]
  • Change in diet [ Time Frame: Baseline, End of study (3 months) ]
  • Change in physical activity [ Time Frame: Baseline, End of study (3 months) ]
  • Change in nicotine consumption [ Time Frame: Baseline, End of study (3 months) ]
  • Change in Sleep [ Time Frame: Baseline, End of study (3 months) ]
  • Change in Body Mass Index (BMI) [ Time Frame: Baseline, End of study (3 months) ]
  • Change in Lipids (non-HDL cholesterol) [ Time Frame: Baseline, End of study (3 months) ]
  • Change in HbA1c [ Time Frame: Baseline, End of study ( 3 months) ]
  • Change in Blood pressure [ Time Frame: Baseline, End of study (3 months) ]

Central Contacts and Locations

Central contacts

Erin Ferranti, PhD

404-712-9551epoe@emory.edu

Ursula Kelly

404-727-2715ukelly@emory.edu

Locations

Southern GA - Colquitt County

Recruiting

Ellenton, Georgia, United States, 31747

Contacts

Stephany Medina-Molina

stephanymolina@emory.edu

More Information

Sponsor

Emory University

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • occupational stress
  • gender related stress
  • social isolation
  • psychological stress
  • cardiometabolic health
  • non biological drivers of health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-06-08.