Community program to reduce heart-related pregnancy risks before conception
Involving Communities in Addressing the Maternal Health Crisis: Making an IMPACT
This program will try pre-pregnancy counseling using a Screening, Brief Intervention, and Referral to Treatment (SBIRT) approach in community settings to help Black women lower cardiovascular risks before pregnancy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 850 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | All |
| Sponsor | Morehouse School of Medicine Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT05987059 on ClinicalTrials.gov |
What this trial studies
The project partners with Healthy Start and similar community-based sites to deliver evidence-based preconception counseling focused on cardiovascular risk factors such as obesity, diabetes, and hypertension. Investigators use a community-engaged approach and a SBIRT model that staff can feasibly deliver to at-risk Black women who are not currently pregnant. The Phase 2 intervention builds on pilot testing that demonstrated capacity to screen for pregnancy risks and provide early intervention in community settings. Implementation occurs through participating community sites with support from Morehouse School of Medicine and NHLBI.
Who should consider this trial
Good fit: Non-pregnant, English-speaking Black/African-American women who receive services at the participating community-based sites and own a phone are the intended participants.
Not a fit: Women who are already pregnant, do not identify as Black/African-American, are not English speakers, or do not access the participating community sites are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could lower pregnancy-related cardiovascular risks and help prevent avoidable maternal morbidity and deaths among Black women by delivering counseling where they already receive services.
How similar studies have performed: Preconception counseling has previously shown benefits for managing obesity, diabetes, and hypertension, and SBIRT approaches have been feasible in pilots, but large-scale community-based trials specifically targeting maternal cardiovascular disparities remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Self-identify as Black/ African-American * Fluent English-Speaker * Not pregnant at the time of enrollment * Own a phone * Receive services at the community-based site Exclusion Criteria: \-
Where this trial is running
Atlanta, Georgia and 1 other locations
- Morehouse School of Medicine — Atlanta, Georgia, United States (Active_not_recruiting)
- Morehouse School of Medicine — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Natalie D. Hernandez, PhD — Associate Professor
- Study coordinator: Madison Haiman, PhD
- Email: mhaiman@msm.edu
- Phone: 470-670-7071
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.