Sisters of Heart for Improving Heart Health

Overseen By Ursula Kelly

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Substance use, Neurologic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special program to determine if peer support and assistance with finding community resources can improve heart health and reduce stress for rural, migrant farmworker women. By enhancing social connections and access to resources, the program aims to improve women's heart health and overall well-being. Participants will either join the Sisters of Heart program (a peer support and resource access initiative) or receive basic heart health information, with the option to switch to the main program after three months. Suitable candidates have worked as migrant farmworkers, speak Spanish or English, and plan to remain in the area for at least six months. As an unphased trial, this study provides a unique opportunity to contribute to research that could strengthen community support systems and improve heart health for similar women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention is safe for improving heart health?

Research has shown that community-based heart health programs, such as the Sisters of Heart intervention, yield promising results in improving heart health. These programs typically focus on education, support, and connecting participants with helpful resources. For example, the Strong Hearts, Healthy Communities Program demonstrated that similar community efforts effectively lower the risk of heart disease in women living in rural areas.

In terms of safety, these programs are generally well-received because they emphasize lifestyle changes and support rather than medication. Participants in similar programs have not reported major side effects, making them a safe choice for those seeking to improve heart health through community support and guidance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sisters of Heart program because it offers a unique, community-driven approach to improving heart health. Unlike traditional medications or surgical interventions, this program emphasizes lifestyle changes and peer support, empowering participants to take charge of their own health. By fostering a supportive network and providing culturally relevant education, Sisters of Heart aims to create sustainable heart-healthy habits, potentially leading to better long-term outcomes without the need for medications.

What evidence suggests that the Sisters of Heart intervention could be effective for improving heart health?

This trial will compare the effectiveness of two interventions: the Sisters of Heart program and a Basic intervention. Studies have shown that community programs like Sisters of Heart can improve heart health by promoting better exercise and eating habits. For instance, a similar program, Strong Hearts, Healthy Communities, successfully encouraged healthier lifestyles and improved health outcomes. Research also shows that programs focusing on historically overlooked groups can effectively reduce heart disease risks. These programs can lower stress, boost social support, and enhance overall mental well-being. While not all community programs lead to significant changes for everyone, they can positively impact specific groups, especially those facing social and economic challenges. ^{1 6 7 8 9}

Who Is on the Research Team?

Erin Ferranti, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for rural, migrant, low-income farmworker women aged 18-45 who may be experiencing stress or have health conditions like diabetes, obesity, hypertension, or prediabetes. It aims to improve their heart health and psychological well-being.

Inclusion Criteria

Fluent in Spanish or English verbal literacy

Planning to be in the geographic area for a minimum of 6 months

I am a woman working as a migrant farmworker.

Exclusion Criteria

Pregnant or breastfeeding

I am mentally capable of understanding and participating in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the CHW-led Sisters of Heart intervention aimed at improving psychological well-being and cardiometabolic health

3 months

Regular visits as per intervention protocol

Basic Intervention

Participants receive the Basic intervention, which includes LE8 assessment and resource information

3 months

Regular visits as per intervention protocol

Follow-up

Participants are monitored for changes in cardiometabolic health and social support outcomes

3-6 months

Follow-up assessments at 3, 6, and 7-9 months

What Are the Treatments Tested in This Trial?

Interventions

• Basic intervention
• Sisters of Heart

Trial Overview The study tests a peer support program called Sisters of Heart against a basic intervention involving health assessments and resource information. The focus is on reducing stress and improving heart health as measured by the American Heart Association's LE8 score.

How Is the Trial Designed?

Group I: Sisters of Heart Experimental Treatment 1 Intervention

Group II: Basic group Experimental Treatment 1 Intervention

Participants randomized to the Basic Intervention will have the option of crossing over to Sisters of Heart (Hermanas de Corazón's) intervention after their 3-month data collection is completed

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK67765/

The effectiveness of community-based heart health projects Community-based interventions are not effective at reducing heart health outcomes at a population level. However, there is some evidence to suggest that ...

2. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-024-01670-y

Process evaluation findings from Strong Hearts, Healthy ... SHHC-2.0 was a 24-week cardiovascular disease prevention program that was effective in improving physical activity and nutrition behaviors and clinical ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001349

Implementation of Evidence-Based Behavioral ... We found several interventions and adaptations aimed at improving outcomes in groups that have historically been excluded by the health care ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9424356/

Dissemination trial for Health for Hearts United: Model ... These findings show that the HHU intervention was effective in improving selected CVD risk outcomes. Although evidence of the efficacy of HHU is growing ...

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S1438887115001387

A Mobile Health Intervention Supporting Heart Failure ... The primary outcome was HF-specific quality of life at 12 months, as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) [ ...

6. brighamandwomens.org brighamandwomens.org/heart-and-vascular-center/programs/pollin-womens-heart-center/heart-disease-prevention-research

Heart Disease Prevention Research The purpose of the WATCH study was to characterize the prevalence and awareness of cardiovascular risk factors among women attending Sister to Sister health ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.123.321998

Life Course Cardiovascular Health: Risk Factors ... CVH measured at any point in life is strongly predictive of future cardiovascular disease, dementia, cancer, and mortality as well as a variety of other health ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7311302/

The Strong Hearts, Healthy Communities Program 2.0 This study demonstrated that the refined SHHC-2.0 program, an experiential multilevel intervention for midlife and older rural women, can improve CVD risk ...

9. dph.illinois.gov dph.illinois.gov/topics-services/prevention-wellness/patient-safety-quality/healthy-hearts-project.html

Healthy Hearts Project - Illinois Department of Public Health Million Hearts is a nationwide initiative to focus, coordinate, and enhance cardiovascular disease prevention activities across the public and private sectors.