The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART)

NCT ID: NCT05499507

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 432 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-24
• Study Completion Date: 2028-12-10

Brief Summary

The overarching goal of our proposal is to reduce disparities in perinatal cardiovascular disease risk factors among Black women utilizing a community-driven, social ecological framework.

Detailed Description

What is this research about? Heart disease (e.g., heart attack, stroke) is a major threat to safe motherhood and is the leading cause of maternal death in the United States, responsible for nearly 50 percent of pregnancy-related deaths among Black women, three times the rate of white women, and is largely preventable. It is well established that eating healthy foods and monitoring blood pressure can help prevent heart disease. While prior studies addressing these individual behaviors have led to some success, a single individual-level approach has not been enough to stop the rising rate of Black maternal mortality. Researchers have also established that depression, social isolation, and stress from racism lead to poor heart outcomes. But few studies have treated these psychosocial and structural factors in addition to individual behaviors to ensure optimal Black maternal heart health, particularly for mothers at higher risk (e.g., those with high blood pressure and/or obesity). To meet this need, the research team plans to compare two approaches that treat multiple factors leading to heart disease among 432 patients age 18 and older who self-identify as Black or African American, have either obesity and/or high blood pressure, are less than 24 weeks pregnant, and have a smart phone. Both approaches address individual behaviors through nutrition and physical activity text messages and home blood pressure self-monitoring as well as provide training to medical care providers in order to reduce patients' experiences of racism or mistreatment. But only one of the approaches being studied also adds supports for Black women by Black women (community doula care, mental health services, and lactation consultation) during their pregnancy, birth, and postpartum in order to learn if these supports lead to lower blood pressure and also treat social isolation, depression, and increase experiences of respectful maternity care.

Who can this research help? This study will increase Black mothers' understanding of the many influences on their heart health. Findings from this study will help Black women with obesity and/or high blood pressure make informed decisions about the use of community doulas, lactation professionals, and psychotherapists as part of their care to reduce risks for heart disease during pregnancy or in the first year after their baby is born. Results may also strengthen health systems' commitment to anti-racism training as part of their efforts to provide quality health care for Black pregnant and postpartum people. And further, this research may provide evidence to insurance companies that coverage of this study's package of supports is needed.

What outcomes are being studied? The primary outcomes are changes in maternal blood pressure and body weight at six weeks and one year after giving birth. The team will also evaluate how well the treatments are implemented and able to reach patients, be adopted into practice consistently, and lead to healthcare provider and patient satisfaction. The team will analyze outcomes that patient partners have identified as important. These include perinatal mood and anxiety disorders (e.g., postpartum depression), emotional and informational support, stress, and experiences of respectful maternity care. In addition, the study team will look at clinical outcomes including if and for how long patients breastfeed, blood pressure disorders of pregnancy, how the patient gave birth (e.g., vaginal or cesarean), baby's birth weight, and how many weeks pregnant mothers were at the time of birth.

How long does this study last? Final follow-up of primary outcomes is at one year postpartum (i.e., approximately 18 months from enrollment).

How are stakeholders involved? The research team believes that efforts to improve Black maternal heart health will be most effective when partnered with patients and community leaders that have shared lived experience. Study leadership is an equitable partnership by an academic physician-researcher and community-based Black provider who herself experienced heart health complications in her pregnancy. There are three other patient investigators who will also be involved in all aspects of the planning, delivery, and evaluation of the treatments, including serving as lead doulas, therapists, and lactation professionals. Patient representatives will make up the majority of the study's advisory board to give feedback and further guide the team's efforts throughout the five years of the project. Finally, patient, health system, and community provider stakeholders will provide feedback and guidance through focus groups over the entire study duration to ensure adoption of treatments.

Conditions

Pregnancy Related; Hypertension; Obesity; Racism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Change of Heart (COH)

Incorporates two, evidence-based individual-level interventions (home blood pressure telemonitoring coupled with the interactive obesity treatment approach, that includes nutrition and physical activity text messages with tailored feedback) and an institutional-level intervention (anti-racism training of providers and staff along with patient feedback to inform respectful care).

Group Type: ACTIVE_COMPARATOR

COH

Intervention Type: BEHAVIORAL

Incorporates two, evidence-based individual-level interventions (home blood pressure telemonitoring coupled with the interactive obesity treatment approach, that includes nutrition and physical activity text messages with tailored feedback) and an institutional-level intervention (anti-racism training of providers and staff along with patient feedback to inform respectful care).

Change of Heart Plus (COH+)

Includes all components of COH plus the addition of interpersonal support for Black women by Black women (community doula care, mental health services, and lactation support).

Group Type: EXPERIMENTAL

COH+

Intervention Type: BEHAVIORAL

Includes all components of COH plus interpersonal support for Black women by Black women (community doula care, mental health services, and lactation support).

Interventions

COH

Incorporates two, evidence-based individual-level interventions (home blood pressure telemonitoring coupled with the interactive obesity treatment approach, that includes nutrition and physical activity text messages with tailored feedback) and an institutional-level intervention (anti-racism training of providers and staff along with patient feedback to inform respectful care).

Intervention Type: BEHAVIORAL

COH+

Includes all components of COH plus interpersonal support for Black women by Black women (community doula care, mental health services, and lactation support).

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon J Herring, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Temple University, Philadelphia, Pennsylvania, United States, 19140

Locations

Temple University/Temple Health

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sharon J Herring, MD, MPH

Role: CONTACT

sharon.herring@temple.edu

2157072234

Christine Santoro, CPM, MA

Role: CONTACT

christy.santoro@temple.edu

Facility Contacts

Sharon J Herring, MD, MPH

Role: primary

herris01@temple.edu

215-707-2234

References

Wycoff KL, Coleman JG, Santoro CM, Zullig LL, Darden N, Holland PM, Cruice JF, Mitchell S, Smith M, McNeil SJ, Herring SJ. Multilevel Community Engagement to Inform a Randomized Clinical Trial. Obstet Gynecol. 2023 Oct 1;142(4):929-939. doi: 10.1097/AOG.0000000000005344. Epub 2023 Sep 7.

Reference Type: DERIVED

PMID: 37734093 (View on PubMed)

Other Identifiers

27919

Identifier Type: -

Identifier Source: org_study_id