Clinical trial NCT05499507: The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART)
Official title: The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Hypertension
Obesity
Racism
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-08-12
Enrollment: 432
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in blood pressure at 6-weeks postpartum.
timeFrame: At baseline and 6-weeks postpartum
measure: Change in blood pressure at 12-months postpartum.
timeFrame: At baseline and 12-months postpartum
measure: Change in body weight at 6-weeks postpartum.
timeFrame: At baseline and 6-weeks postpartum
measure: Change in body weight at 12-months postpartum.
timeFrame: At baseline and 12-months postpartum
Secondary outcomes:
measure: Change in emotional support at 6-weeks postpartum.
timeFrame: At baseline and 6-weeks postpartum
measure: Change in emotional support at 12-months postpartum.
timeFrame: At baseline and 12-months postpartum
measure: Change in informational support at 6-weeks postpartum.
timeFrame: At baseline and 6-weeks postpartum
measure: Change in informational support at 12-months postpartum.
timeFrame: At baseline and 12-months postpartum
measure: Change in Perinatal Mood and Anxiety Disorders (PMADs) at 6-weeks postpartum.
timeFrame: At baseline and 6-weeks postpartum
measure: Change in PMADs at 12-months postpartum.
timeFrame: At baseline and 12-months postpartum
measure: Mothers autonomy in decision making at baseline.
timeFrame: Baseline
measure: Mothers autonomy in decision making at 6-weeks postpartum.
timeFrame: 6-weeks postpartum
measure: Respectful maternity care at baseline.
timeFrame: Baseline
measure: Respectful maternity care at 6-weeks postpartum.
timeFrame: 6-weeks postpartum
measure: Obstetric mistreatment at baseline.
timeFrame: Baseline
measure: Obstetric mistreatment at 6-weeks postpartum
timeFrame: 6-weeks postpartum
measure: Blood pressure control at 6-weeks postpartum for patients with hypertension (HTN) at baseline.
timeFrame: 6-weeks postpartum
measure: Blood pressure control at 12-months postpartum for patients with hypertension at baseline.
timeFrame: 12-months postpartum
measure: Incident hypertension at 6-weeks postpartum for patients who were normotensive at baseline.
timeFrame: 6-weeks postpartum
measure: Incident hypertension at 12-months postpartum for patients who were normotensive at baseline.
timeFrame: 12-months postpartum
measure: Breast/Chestfeeding initiation.
timeFrame: 6-weeks postpartum
measure: Breast/Chestfeeding duration.
timeFrame: 12-months postpartum
measure: Breastfeeding support/self-efficacy at 6-weeks postpartum.
timeFrame: 6-weeks postpartum
measure: Breastfeeding support/self-efficacy at 12-months postpartum.
timeFrame: 12-months postpartum
measure: Mode of delivery.
timeFrame: 6-weeks postpartum
measure: Infant birth weight.
timeFrame: 6-weeks postpartum
measure: Preterm birth.
timeFrame: 6-weeks postpartum
measure: Blood pressure change at 32-34 weeks gestation.
timeFrame: Baseline and 32-34 weeks gestation
measure: Blood pressure change at 1 week postpartum.
timeFrame: Baseline and 1-week postpartum
measure: Blood pressure change at 12 weeks postpartum.
timeFrame: Baseline and 12-weeks postpartum
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University/Temple Health
state: Pennsylvania
Study officials:
affiliation: Temple University, Philadelphia, Pennsylvania, United States, 19140
name: Sharon J Herring, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: