Sisters for Heart Health: A Community Health Worker Initiative for Improving Heart Health in Farmworker Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sisters for Heart Health, Basic intervention.
- Who it may be relevant to
- Registry conditions: Occupational Stress, Gender Related Stress, Social Isolation, Hypertension. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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, farmworker women face disproportionate risk factors and health burdens related to CVD, yet they remain underrecognized and insufficiently reached in prevention efforts. Although about 45% of women above the age of 20 are affected by CVD, only 44% of women recognize CVD as their top health threat Women farmworkers in rural areas face a compounded risk due to the convergence of biological and non-biological drivers of health. 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. Less than 50% of women enter pregnancy with optimal CVH. The American Heart Association's Life's Essential 8 (LE8) provides a validated framework to measure and improve CVH.
To address this, the study proposes a Community Health Worker (CHW)-led peer support intervention, Sisters for Heart Health, targeting rural, low-income, reproductive-aged women farmworkers. Peer and social support groups led by CHWs are evidence-based interventions for mitigating the impacts of chronic stress, increasing social support, increasing access to resources, delivering health education, and reducing cardiometabolic risk for women; but these have yet to be adapted and tested among women farmworkers in rural settings.
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 an intervention to female farmworkers * Embedding person-centered approaches into CVD prevention * Addressing non-biologic drivers of health-related stress and unmet needs * Equipping CHWs to support peer behavior change and health system navigation * Laying the groundwork for scaling and sustaining community-based CVH strategies in a rural setting
Interventions
- Behavioral 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 - 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 Farm Worker Clinic and a community resource list
Primary outcome measures
- 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)]
Secondary outcome measures (11)
- Social Isolation [Time frame: Baseline, End of study (3 months)]
- Participant Satisfaction [Time frame: T1 (1.2 months) ,T2 (3 months), T3 (6 months), T4 (7-9 months)]
- Instrumental support [Time frame: Baseline, End of study (3 months)]
- Companionship support [Time frame: Baseline, End of study (3 months)]
- Informational Support SF 8a [Time frame: Baseline, End of study (3 months)]
- Emotional Support [Time frame: Baseline, End of study (3 months)]
- Gender related stress [Time frame: Baseline, End of study (3 months)]
- Occupational stress [Time frame: Baseline, End of study (3 months)]
- Social needs [Time frame: Baseline. End of study (3 months)]
- Childhood trauma exposure [Time frame: Baseline, End of study (3 months)]
- Lifetime trauma exposure [Time frame: Baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Southern GA - Colquitt County — Ellenton
Identifiers
NCT: NCT07111026 · STUDY00008487 · 1R01NR021664-01