NCT05499507 · Temple University
The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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).
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).
Primary outcome measures
Change in blood pressure at 6-weeks postpartum.
Time frame: At baseline and 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.
Change in blood pressure at 12-months postpartum.
Time frame: At baseline and 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.
Change in body weight at 6-weeks postpartum.
Time frame: At baseline and 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.
Change in body weight at 12-months postpartum.
Time frame: At baseline and 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Philadelphia, Pennsylvania
Collaborators
Patient-Centered Outcomes Research Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 11, 2025 · Source of record for eligibility and locations