Sisters for Heart Health: A Community Health Worker Initiative for Improving Heart Health in Farmworker Women

Part of paid clinical trials in Ellenton, Georgia.

Sponsor
Emory University
Study ID
NCT07111026
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Sisters for Heart Health — BEHAVIORAL
    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 — 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 Farm Worker Clinic and a community resource list

Study Details

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.

Key Dates

Start date
Sep 16, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
269 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

Primary Outcome Measure

Change in cardiometabolic health [ Time Frame: T-0 (Baseline) ,T2 (3 months), T3 (6 months), T4 (7-9 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Southern GA - Colquitt CountyEllentonGeorgia31747
Stephany Medina-Molina
[email protected]

Find similar trials in Ellenton, GA

By condition
Hypertension (high blood pressure)Obesity / overweight
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
Southern GA - Colquitt County· Ellenton, GA

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