Lifestyle intervention to reduce preeclampsia in African American women
Social Risks-Focused Lifestyle Intervention to Reduce Preeclampsia in AA Women
This study is testing a lifestyle program to see if it can help reduce preeclampsia and lower blood pressure in African American women during pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Wauwatosa, Wisconsin) |
| Trial ID | NCT04958057 on ClinicalTrials.gov |
What this trial studies
This study aims to address the growing issue of preeclampsia, particularly among African American women, by testing a lifestyle intervention focused on social risk factors. The intervention will involve a randomized control trial with 100 participants, where women will attend six monthly group sessions during their second and third trimesters. The study will evaluate the feasibility, acceptability, and efficacy of this approach in reducing blood pressure and preeclampsia rates compared to routine prenatal care. By focusing on social determinants of health, the study seeks to fill a significant gap in current research.
Who should consider this trial
Good fit: Ideal candidates for this study are African American women living in inner-city Milwaukee who are pregnant and have a gestational age of 16 weeks or less.
Not a fit: Patients who may not benefit from this study include those with major fetal anomalies or psychiatric illnesses that prevent group participation.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of preeclampsia and improve health outcomes for African American women during pregnancy.
How similar studies have performed: While there is limited research specifically targeting social risks-focused lifestyle interventions for preeclampsia, the approach is innovative and aims to address a critical gap in existing studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * self-report as African-American/Non-Hispanic black * residence in inner-city Milwaukee * nulliparity * gestational age at enrollment \<=16 weeks * able and willing to give informed consent Exclusion Criteria: * not able to communicate in English * major fetal anomaly * psychiatric illness that precludes group participation
Where this trial is running
Wauwatosa, Wisconsin
- Medical College of Wisconsin — Wauwatosa, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Anna Palatnik, MD
- Email: apalatnik@mcw.edu
- Phone: 414-805-6627
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.