Sisters for Heart Health: A Community Health Worker Initiative for Improving Heart Health in Farmworker Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 269
- 试验地点
- 2
- 主要终点
- Change in cardiometabolic health
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Basic intervention (Behavioral)
结局指标
主要结局
Change in cardiometabolic health
时间窗: T-0 (Baseline) ,T2 (3 months), T3 (6 months), T4 (7-9 months)
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.
Change in diet
时间窗: Baseline, End of study (3 months)
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.
Change in nicotine consumption
时间窗: Baseline, End of study (3 months)
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
Change in Sleep
时间窗: Baseline, End of study (3 months)
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.
Change in Body Mass Index (BMI)
时间窗: Baseline, End of study (3 months)
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.
Change in Lipids (non-HDL cholesterol)
时间窗: Baseline, End of study (3 months)
Change in lipid levels throughout the study.
Change in HbA1c
时间窗: Baseline, End of study ( 3 months)
Change in the HbA1c levels during the study will be reported
Change in Blood pressure
时间窗: Baseline, Emd of study (3 months)
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.
Change in physical activity
时间窗: Baseline, End of study (3 months)
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 our target population. 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
Change in cardiometabolic health
时间窗: T-0 (Baseline) ,T2 (3 months), T3 (6 months), T4 (7-9 months)
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.
Change in diet
时间窗: Baseline, End of study (3 months)
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.
Change in physical activity
时间窗: Baseline, End of study (3 months)
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
Change in nicotine consumption
时间窗: Baseline, End of study (3 months)
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
Change in Sleep
时间窗: Baseline, End of study (3 months)
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.
Change in Body Mass Index (BMI)
时间窗: Baseline, End of study (3 months)
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.
Change in Lipids (non-HDL cholesterol)
时间窗: Baseline, End of study (3 months)
Change in lipid levels throughout the study.
Change in HbA1c
时间窗: Baseline, End of study ( 3 months)
Change in the HbA1c levels during the study will be reported
Change in Blood pressure
时间窗: Baseline, Emd of study (3 months)
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.
次要结局
- 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))
- Emotional Support(Baseline, End of study (3 months))
- Childhood trauma exposure(Baseline, End of study (3 months))
- Lifetime trauma exposure(Baseline)
- Gender related stress(Baseline, End of study (3 months))
- Social Isolation(Baseline, End of study (3 months))
- Occupational stress(Baseline, End of study (3 months))
- Social needs(Baseline. End of study (3 months))
- 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))
- Emotional Support(Baseline, End of study (3 months))
- Gender related stress(Baseline, End of study (3 months))
- Occupational stress(Baseline, End of study (3 months))
- Social needs(Baseline. End of study (3 months))
- Childhood trauma exposure(Baseline, End of study (3 months))
- Lifetime trauma exposure(Baseline)
研究者
Erin Ferranti
Associate Professor
Emory University