Project Summary
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Black women are more than three times more likely to die during pregnancy or after pregnancy than White women. Heart disease causes nearly half of pregnancy-related deaths among Black women. Certain behaviors, such as eating healthy foods and monitoring blood pressure, can help prevent heart disease. But programs that focus on these behaviors alone have not solved the high rates of mortality among Black mothers. Few programs for improving heart health have addressed other factors shown to cause poor heart outcomes among Black women such as depression, loneliness, and stress from racism.
In this study, the research team is comparing two ways to improve heart health for Black birthing people:
- Change of Heart is a program that includes tailored feedback on nutrition and exercise and remote patient monitoring, or RPM. In RPM, doctors monitor people’s blood pressure at home by phone or using other devices. Clinic staff also receive training to help them provide care that considers birthing people’s experiences with racism.
- Change of Heart Plus includes all aspects of the Change of Heart program plus support from community providers with lived experience, such as doulas. This program also includes infant feeding support from lactation counselors and mental health screenings with therapists who provide referrals to treatment when needed.
Who can this research help?
Results may help health systems and clinics when considering ways to improve health outcomes for Black birthing people during and after pregnancy.
What is the research team doing?
The research team is enrolling 432 Black pregnant people with obesity, high blood pressure, or both. All receive care from obstetric clinics in Philadelphia, Pennsylvania. The team is assigning people by chance to receive Change of Heart or Change of Heart Plus.
The research team is measuring people’s blood pressure and weight six weeks and one year after birth. The team is also surveying people in the study to learn about their:
- Feelings of being emotionally supported and having access to helpful information
- Experience coping with stressful situations
- Current mood and level of anxiety
- Experiences with respectful care or mistreatment at prenatal, birth, and postpartum visits
- Infant feeding choices
- Baby’s birth weight
A researcher and a community-based Black provider who experienced heart problems during pregnancy are leading this study together. Black patients, doulas, therapists, breastfeeding counselors, health system staff, and doctors are helping to plan and conduct the study.
Research methods at a glance
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 432 pregnant adults ages 18 and older who self-identify as Black or African American with BMI ≥30 kg/m2 and/or a diagnosis of hypertension (≥130/80 x 2) and gestational age <28 weeks |
| Interventions/ Comparators |
|
| Outcomes |
Primary: blood pressure and body weight at 6 weeks and 1 year postpartum Secondary: emotional support, informational support, perinatal depression and anxiety, autonomy in decision making, respectful maternity care, obstetric mistreatment, blood pressure control, incident hypertension, breast/chestfeeding initiation, breast/chestfeeding duration, breast/chestfeeding self-efficacy, mode of delivery (cesarean section or vaginal delivery), infant birth weight, preterm birth, blood pressure at 32–34 weeks gestation and 1 and 3 months postpartum |
| Timeframe | Up to 1-year follow-up for primary outcomes |
