About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Sisters for Heart Health
BehavioralThe 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 intervention
BehavioralThe 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
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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
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
Secondary outcomes
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.
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
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.
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.
Sponsors and contacts
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Emory University
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator