An interventional study of Sisters for Heart Health and Basic intervention in Occupational Stress, Gender Related Stress and Social Isolation, sponsored by Emory University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Emory University · Not applicable, Interventional, and Prevention
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:
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.
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:
236 studies on the registry are indexed under Occupational Stress; 63 are open to participants now.
This study's planned enrollment of 269 is above the median of 84 across 168 interventional studies indexed under Occupational Stress.
Browse Occupational Stress studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Sisters for Heart Health
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
Behavioral: Basic intervention
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.
Also known as: Hermanas de Corazon
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
Change in cardiometabolic health
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.
Time frame: T-0 (Baseline) ,T2 (3 months), T3 (6 months), T4 (7-9 months)
Change in diet
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.
Time frame: Baseline, End of study (3 months)
Change in physical activity
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
Time frame: Baseline, End of study (3 months)
Change in nicotine consumption
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
Time frame: Baseline, End of study (3 months)
Change in Sleep
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.
Time frame: Baseline, End of study (3 months)
Change in Body Mass Index (BMI)
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.
Time frame: Baseline, End of study (3 months)
Change in Lipids (non-HDL cholesterol)
Change in lipid levels throughout the study.
Time frame: Baseline, End of study (3 months)
Change in HbA1c
Change in the HbA1c levels during the study will be reported
Time frame: Baseline, End of study ( 3 months)
Change in Blood pressure
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.
Time frame: Baseline, End of study (3 months)
Social Isolation
Social Isolation will be assessed with the PROMIS Social Isolation SF 8a. Eight items related to perceived feelings of being excluded or disconnected from others are scored on a five-point scale (0-4 = "never" to "always"). Responses are summed to create a raw total score (0-32) that is then rescaled into a standardized score with a mean of 50 and a standard deviation of 10. It has been validated in the target population.
Time frame: Baseline, End of study (3 months)
Participant Satisfaction
Client Satisfaction Questionnaire (CSQ-8), an 8-item scale using a 4-point scale ("quite dissatisfied" to "very satisfied") will be administered to determine the extent to which participants' needs were met
Time frame: T1 (1.2 months) ,T2 (3 months), T3 (6 months), T4 (7-9 months)
Instrumental support
Instrumental support will be assessed by study documentation of referrals for social needs or non-biological drivers of health-related factors, CHW resource navigation, and participants' self-reports about services offered and services received. We recognize that services offered are not necessarily accepted or received, given participants' autonomy and restraints.
Time frame: Baseline, End of study (3 months)
Companionship support
Companionship support will be assessed using the Multidimensional Scale of Perceived Social Support, a 12-item survey to assess three sources of support - Family, Friends, and Romantic Partner Each subscale score is the mean of its four items. * The total score is the mean of all 12 items. * Higher scores indicate greater perceived support.
Time frame: Baseline, End of study (3 months)
Informational Support SF 8a
This includes 8 items scored on a five-point scale ("never" to "always")
Time frame: Baseline, End of study (3 months)
Emotional Support
This will be assessed using the PROMIS Emotional Support SF 8a, which includes 8 items scored on a five-point scale ("never" to "always").
Time frame: Baseline, End of study (3 months)
Gender related stress
Gender-related stress will be assessed with the Women's Social Stressor Scale (HWSSS) which is a reliable and valid measure of the social stressors experienced by our target population. It is a 41-item scale with 6 subscales - immigration, socioeconomic, racism-related, familial, parental, and employment
Time frame: Baseline, End of study (3 months)
Occupational stress
Occupational stress will be assessed with the Farmworker Stress Inventory (MFWSI), a 39-item self-report instrument that assesses the quality and severity of stress inherent in farmworker; it was developed for adult farmworkers. The MFWSI requires a 6th-grade literacy level and can be verbally administered if necessary. Each item is scored from 0 to 4. The total MFWSI score is obtained by summing the scores for all 39 items. Possible MFWSI scores range from 0 to 156, with higher scores indicating a greater degree of stress related to the farmworker lifestyle.
Time frame: Baseline, End of study (3 months)
Social needs
Social needs will be assessed using the Centers for Medicare \& Medicaid Services Health-Related Social Needs Tool (HRSN), a 10-item scale covering 5 domains (housing, food, transportation, utilities, and interpersonal safety) with positive responses indicating an associated social need.62 We will assess social needs at baseline and at subsequent timepoints, ask about any changes, and what prompted those changes (participant/CHW initiated or external factor).
Time frame: Baseline. End of study (3 months)
Childhood trauma exposure
Childhood trauma exposure will be assessed with the Adverse Childhood Events (ACES) Questionnaire, a 10-item self-report measure of personal experiences of physical, emotional, or sexual abuse or neglect (5 questions) and experiences of adversity related to family members, e.g., mental illness, incarceration, death.25 Each item is scored with one point for each experience. Total scores (number of ACES) are associated with increased risk of toxic stress and health conditions Higher ACE scores correlate with greater risk for chronic diseases, mental health disorders, substance use, and social challenges later in life
Time frame: Baseline, End of study (3 months)
Lifetime trauma exposure
Lifetime trauma exposure will be assessed with the Life Events Checklist (LEC-5) -a 17-item measure of lifetime trauma, including type and frequency. Respondents indicate varying levels of exposure to each type of potentially traumatic event included on a 6-point nominal scale, and respondents may endorse multiple levels of exposure to the same trauma type. The LEC-5 does not yield a total score or composite score.
Time frame: Baseline
Plan to share: Yes — The shared data will include de-identified quantitative and qualitative data collected through: Surveys (social, behavioral, clinical data, including anthropometric and blood pressure measures) Clinical lab results (e.g., lipid panel, Hgb A1c) Transcripts from semi-structured interviews Data analysis files (e.g., SAS, SPSS, R, and MAXQDA outputs) Data dictionaries and supporting metadata
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: De-identified data will be made available no later than the time of publication of primary results or at the end of the funding period, whichever occurs first. Data will remain available indefinitely in the Emory Dataverse for continued public access.
Access criteria: Data will be shared with qualified investigators who have an appropriate research question and an approved Data Use Agreement (DUA). Data may be used for secondary analyses consistent with the original informed consent and within the scope of social, behavioral, and clinical research related to cardiovascular health, non-biologic drivers of health, and intervention outcomes. Data will be shared through the Emory Dataverse repository. All datasets will be assigned Digital Object Identifiers (DOIs), accompanied by relevant documentation, and made available via secure access mechanisms defined by Emory Dataverse policy
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Dec 2028, 39 months after the start.
Of 125 non-industry interventional studies with no phase under Occupational Stress, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 28. This study's planned 39 months is above that.
Counting every sponsor, half of 133 studies reached it within 10 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
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