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

Study Overview
=================
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.

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

Conditions
-----------------
Pregnancy Related, Hypertension, Obesity, Racism

Intervention / Treatment
-----------------
* Behavioral: COH
* Behavioral: COH+


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Change of Heart (COH)<br>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). | Behavioral: COH<br>* 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).<br>|
| Experimental: Change of Heart Plus (COH+)<br>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). | Behavioral: COH+<br>* Includes all components of COH plus interpersonal support for Black women by Black women (community doula care, mental health services, and lactation support).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure at 6-weeks postpartum. | Blood pressure will be measured at each time point on the upper arm three times at one-minute intervals after five minutes of quiet sitting. The investigators will use the validated Omron HEM-907XL and the appropriate size cuff. The investigators will average the three measures for analysis. | At baseline and 6-weeks postpartum | 
| Change in blood pressure at 12-months postpartum. | Blood pressure will be measured at each time point on the upper arm three times at one-minute intervals after five minutes of quiet sitting. The investigators will use the validated Omron HEM-907XL and the appropriate size cuff. The investigators will average the three measures for analysis. | At baseline and 12-months postpartum | 
| Change in body weight at 6-weeks postpartum. | Body weight will be measured in duplicate and recorded to the nearest 0.1kg using calibrated SECA scales at each time point. | At baseline and 6-weeks postpartum | 
| Change in body weight at 12-months postpartum. | Body weight will be measured in duplicate and recorded to the nearest 0.1kg using calibrated SECA scales at each time point. | At baseline and 12-months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in emotional support at 6-weeks postpartum. | The investigators will use the 8-item emotional support PROMIS instrument to measure perceived feelings of being cared for at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater emotional support. | At baseline and 6-weeks postpartum | 
| Change in emotional support at 12-months postpartum. | The investigators will use the 8-item emotional support PROMIS instrument to measure perceived feelings of being cared for at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater emotional support. | At baseline and 12-months postpartum | 
| Change in informational support at 6-weeks postpartum. | The investigators will use the 8-item informational support PROMIS instruments to measure perceived availability of helpful information or advice at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater informational support. | At baseline and 6-weeks postpartum | 
| Change in informational support at 12-months postpartum. | The investigators will use the 8-item informational support PROMIS instruments to measure perceived availability of helpful information or advice at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater informational support. | At baseline and 12-months postpartum | 
| Change in Perinatal Mood and Anxiety Disorders (PMADs) at 6-weeks postpartum. | PMADs will be assessed using the Beck Depression Inventory II (BDI-II), a 21-item screening tool. The BDI-II has demonstrated concurrent validity with other postpartum depression scales and validated cut points for mild/moderate depressive symptoms in Black women of low-socioeconomic position. The lowest possible raw score is 1; the highest possible raw score is 40. Higher scores indicate greater depressive symptoms. | At baseline and 6-weeks postpartum | 
| Change in PMADs at 12-months postpartum. | PMADs will be assessed using the Beck Depression Inventory II (BDI-II), a 21-item screening tool. The BDI-II has demonstrated concurrent validity with other postpartum depression scales and validated cut points for mild/moderate depressive symptoms in Black women of low-socioeconomic position. The lowest possible raw score is 1; the highest possible raw score is 40. Higher scores indicate greater depressive symptoms. | At baseline and 12-months postpartum | 
| Mothers autonomy in decision making at baseline. | The 7-item Mothers Autonomy in Decision Making scale rates patients' level of agency and autonomy experienced during conversations with a maternity provider. The range of scores is 7-42, with higher scores indicating more opportunities to take an active role and lead decisions. | Baseline | 
| Mothers autonomy in decision making at 6-weeks postpartum. | The 7-item Mothers Autonomy in Decision Making scale rates patients' level of agency and autonomy experienced during conversations with a maternity provider. The range of scores is 7-42, with higher scores indicating more opportunities to take an active role and lead decisions. | 6-weeks postpartum | 
| Respectful maternity care at baseline. | Respectful maternity care will be assessed by the 14-item Mothers on Respect Index, which examines the nature of provider-patient relationships and access to person-centered care. The range of scores is 14-84, with higher scores indicating more respectful care. lead decisions. | Baseline | 
| Respectful maternity care at 6-weeks postpartum. | Respectful maternity care will be assessed by the 14-item Mothers on Respect Index, which examines the nature of provider-patient relationships and access to person-centered care. The range of scores is 14-84, with higher scores indicating more respectful care. | 6-weeks postpartum | 
| Obstetric mistreatment at baseline. | The 8-item Mistreatment Index queries patients' experience of dimensions of mistreatment (e.g., physical abuse, discrimination). To describe the overall prevalence of mistreatment, the investigators will calculate the proportion of women who experienced each of the seven types of mistreatment and what proportion experience any mistreatment (i.e. any of the seven indicators). | Baseline | 
| Obstetric mistreatment at 6-weeks postpartum | The 8-item Mistreatment Index queries patients' experience of dimensions of mistreatment (e.g., physical abuse, discrimination). To describe the overall prevalence of mistreatment, the investigators will calculate the proportion of women who experienced each of the seven types of mistreatment and what proportion experience any mistreatment (i.e. any of the seven indicators). | 6-weeks postpartum | 
| Blood pressure control at 6-weeks postpartum for patients with hypertension (HTN) at baseline. | Blood pressure control will be assessed at each time point for patients with HTN at enrollment (proportion with mean systolic BP ≥ 130mm/Hg or mean diastolic BP ≥ 80mm/Hg). | 6-weeks postpartum | 
| Blood pressure control at 12-months postpartum for patients with hypertension at baseline. | Blood pressure control will be assessed at each time point for patients with HTN at enrollment (proportion with mean systolic BP ≥ 130mm/Hg or mean diastolic BP ≥ 80mm/Hg). | 12-months postpartum | 
| Incident hypertension at 6-weeks postpartum for patients who were normotensive at baseline. | Data will be collected about incident HTN at 6-weeks and 1-year postpartum for normotensive patients at enrollment (proportion with mean systolic BP ≥130 mm/Hg or mean diastolic BP ≥ 80mm/Hg). | 6-weeks postpartum | 
| Incident hypertension at 12-months postpartum for patients who were normotensive at baseline. | Data will be collected about incident HTN at 6-weeks and 1-year postpartum for normotensive patients at enrollment (proportion with mean systolic BP ≥130 mm/Hg or mean diastolic BP ≥ 80mm/Hg). | 12-months postpartum | 
| Breast/Chestfeeding initiation. | Breast/chestfeeding initiation will be assessed via questions adapted from the Infant Feeding Practices Study II. | 6-weeks postpartum | 
| Breast/Chestfeeding duration. | Breast/chestfeeding duration will be assessed via questions adapted from the Infant Feeding Practices Study II. | 12-months postpartum | 
| Breastfeeding support/self-efficacy at 6-weeks postpartum. | Breast/chestfeeding self-efficacy will be assessed via questions adapted from the Breastfeeding Self-Efficacy Scale. The range of scores is 14-70, with higher scores indicating greater self-efficacy. | 6-weeks postpartum | 
| Breastfeeding support/self-efficacy at 12-months postpartum. | Breast/chestfeeding self-efficacy will be assessed via questions adapted from the Breastfeeding Self-Efficacy Scale. he range of scores is 14-70, with higher scores indicating greater self-efficacy. | 12-months postpartum | 
| Mode of delivery. | Mode of delivery will be abstracted from the electronic health record and categorized as either operative delivery (cesarean section) or non-operative (vaginal delivery), stratified by birth history. | 6-weeks postpartum | 
| Infant birth weight. | Infant birth weight will be abstracted from electronic health record. The investigators will calculate sex-specific birth weight for gestational age percentile based on national data. | 6-weeks postpartum | 
| Preterm birth. | To determine rates of preterm birth, gestational length will be calculated from last menstrual period (LMP) unless ultrasound dating differs ≥10 days from LMP dating. Pregnancy loss will be assessed by self-report, verified by electronic health record. | 6-weeks postpartum | 
| Blood pressure change at 32-34 weeks gestation. | Assessed through validated home blood pressure telemonitoring devices to reduce patient burden so to not miss shifts in BP from normotensive to hypertensive during critical periods of elevated CVD risk - shifts that would prompt more intensive monitoring and earlier treatment. | Baseline and 32-34 weeks gestation | 
| Blood pressure change at 1 week postpartum. | Assessed through validated home blood pressure telemonitoring devices to reduce patient burden so to not miss shifts in BP from normotensive to hypertensive during critical periods of elevated CVD risk - shifts that would prompt more intensive monitoring and earlier treatment. | Baseline and 1-week postpartum | 
| Blood pressure change at 12 weeks postpartum. | Assessed through validated home blood pressure telemonitoring devices to reduce patient burden so to not miss shifts in BP from normotensive to hypertensive during critical periods of elevated CVD risk - shifts that would prompt more intensive monitoring and earlier treatment. | Baseline and 12-weeks postpartum |