Occupational StressNCT07111026
Sisters for Heart Health: A Community Health Worker Initiative for Improving Heart Health in Farmworker Women
A study testing Sisters for Heart Health and Basic intervention in people with Occupational Stress and Gender Related Stress, run by Emory University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Occupational Stress, Gender Related Stress, Social Isolation
- What is being tested?
- Sisters for Heart Health and Basic intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2025to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Southern GA - Colquitt County
Ellenton, Georgia, 31747
Stephany Medina-Molina, stephanymolina@emory.edu
About this study
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.
Read the 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
- Conditions
- Occupational Stress, Gender Related Stress, Social Isolation, Hypertension, Pre Diabetes, Diabetes
- Being tested
- Sisters for Heart Health, Basic intervention
- Keywords
- occupational stress, gender related stress, social isolation, psychological stress, cardiometabolic health, non biological drivers of health
- Medical subject headings
- Occupational Stress, Social Isolation, Hypertension, Glucose Intolerance, Diabetes Mellitus, Obesity, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sisters for Heart HealthBehavioural
Also called Hermanas de Corazon
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 interventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Sisters for Heart Health | Experimental | Not described Receives: Behavioral: Sisters for Heart Health |
| Basic group | Other | 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 Receives: Behavioral: Basic intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline, End of study (3 months)
Change in Lipids (non-HDL cholesterol)
Change in lipid levels throughout the study.
Measured: Baseline, End of study (3 months)
Change in HbA1c
Change in the HbA1c levels during the study will be reported
Measured: 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.
Measured: Baseline, End of study (3 months)
Secondary outcomes (11)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline, End of study (3 months)
Informational Support SF 8a
This includes 8 items scored on a five-point scale ("never" to "always")
Measured: 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").
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start16 Sep 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational StressStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 269 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Erin Ferranti, Emory University
- Investigators
- Erin Ferranti, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111026
- Sponsor's protocol ID
- STUDY00008487
- Other IDs
- 1R01NR021664-01
- Status last verified
- Jun 2026
- First submitted
- 22 Jul 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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