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

Обзор

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.

Подробное описание

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

Вмешательства

• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

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

Вторичные конечные точки (11)

• Social Isolation [Срок оценки: Baseline, End of study (3 months)]
• Participant Satisfaction [Срок оценки: T1 (1.2 months) ,T2 (3 months), T3 (6 months), T4 (7-9 months)]
• Instrumental support [Срок оценки: Baseline, End of study (3 months)]
• Companionship support [Срок оценки: Baseline, End of study (3 months)]
• Informational Support SF 8a [Срок оценки: Baseline, End of study (3 months)]
• Emotional Support [Срок оценки: Baseline, End of study (3 months)]
• Gender related stress [Срок оценки: Baseline, End of study (3 months)]
• Occupational stress [Срок оценки: Baseline, End of study (3 months)]
• Social needs [Срок оценки: Baseline. End of study (3 months)]
• Childhood trauma exposure [Срок оценки: Baseline, End of study (3 months)]
• Lifetime trauma exposure [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Southern GA - Colquitt County — Ellenton

Идентификаторы

NCT: NCT07111026 · STUDY00008487 · 1R01NR021664-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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