Comparing two interventions to improve heart health in Black pregnant women
The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART)
This study is testing two different programs to see which one helps Black pregnant women with obesity or high blood pressure improve their heart health by focusing on healthy habits and support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 432 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Temple University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05499507 on ClinicalTrials.gov |
What this trial studies
This research aims to reduce cardiovascular disease risk factors among Black women during pregnancy by comparing two community-driven interventions. The study focuses on addressing both individual behaviors, such as nutrition and physical activity, and psychosocial factors like stress and social isolation that contribute to heart disease. A total of 432 participants who are Black or African American, pregnant, and have obesity or high blood pressure will be enrolled to evaluate the effectiveness of these interventions. The study utilizes a social ecological framework to ensure a comprehensive approach to maternal heart health.
Who should consider this trial
Good fit: Ideal candidates for this study are Black or African American women aged 18 and older, who are less than 24 weeks pregnant and have obesity or high blood pressure.
Not a fit: Patients who do not identify as Black or African American or who are not pregnant may not receive benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the rates of cardiovascular disease and improve maternal health outcomes for Black women.
How similar studies have performed: Other studies have shown success in addressing individual health behaviors, but this comprehensive approach targeting both psychosocial and structural factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age ≥18 years * baseline BMI ≥30 kg/m2 and/or diagnosis of HTN (≥130/80 x 2) * gestational age \<24 weeks by last menstrual period * smartphone ownership * self-identification as Black or African American
Where this trial is running
Philadelphia, Pennsylvania
- Temple University/Temple Health — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Sharon J Herring, MD, MPH — Temple University, Philadelphia, Pennsylvania, United States, 19140
- Study coordinator: Sharon J Herring, MD, MPH
- Email: sharon.herring@temple.edu
- Phone: 2157072234
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.