Sisters for Heart Health: A Community Health Worker Initiative for Improving Heart Health in Farm… (NCT07111026) | Clinical Trial Compass
RecruitingNot Applicable
Sisters for Heart Health: A Community Health Worker Initiative for Improving Heart Health in Farmworker Women
United States269 participantsStarted 2025-09-16
Plain-language 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, 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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses specifically on farmworker women facing occupational stress, gender-related stress, and social isolation alongside conditions like hypertension, pre-diabetes, or obesity — given my own situation, does my doctor think these overlapping risk factors match what this study is designed to address?
2The program uses community health workers rather than clinical staff to support heart health changes — can my doctor help me understand whether this kind of peer-based support would be a good fit for where I am in managing my blood pressure, blood sugar, or weight right now, or whether I should prioritize a more medical approach first?
3Since this is listed as Phase NA and is measuring changes in things like HbA1c, cholesterol, BMI, and blood pressure over time, can my doctor explain what that means for how much is already known about whether this approach is safe and effective for someone with my health history?
4The trial is actively recruiting and tracks things like sleep, physical activity, diet, and nicotine use — can my doctor walk me through what kind of time commitment or lifestyle monitoring this would realistically involve, and whether that's manageable given everything else I'm dealing with?
5Are there standard-of-care options for managing my specific conditions — like pre-diabetes or hypertension — that my doctor would recommend I consider alongside or before exploring whether this trial might be worth discussing further with the research team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.