The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART)
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
United States
Pennsylvania
Temple University/Temple Health
RECRUITING
Philadelphia
Contact Information
Primary
Sharon J Herring, MD, MPH
sharon.herring@temple.edu
2157072234
Backup
Christine Santoro, CPM, MA
christy.santoro@temple.edu
Time Frame
Start Date: 2023-01-24
Estimated Completion Date: 2028-12-10
Participants
Target number of participants: 432
Treatments
Active_comparator: 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).
Experimental: 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).
Related Therapeutic Areas
Sponsors
Leads: Temple University
Collaborators: Patient-Centered Outcomes Research Institute