Community Health Worker Coaching to Reduce Cardiovascular Risk Among Women After a Hypertensive Disorder of Pregnancy (HERHEART)

Community Health Worker Coaching to Reduce CVD Disease Risk Among Women After a Hypertensive Disorder of Pregnancy

The goal of this clinical trial is to find out whether an enhanced program works better than remote blood pressure monitoring (RBPM) alone for women who had high blood pressure during pregnancy. The enhanced program combines RBPM with a lifestyle program led by a community health worker (CHW).

The study will examine whether the enhanced program helps women better control their blood pressure, lowers their average resting blood pressure, improves heart health risk factors (such as weight, diet, physical activity), supports mental well-being, and reduces emergency department visits and hospital readmissions by 6 months after delivery.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Hypertension (HTN); Blood Pressure Monitoring
• Intervention / Treatment: Behavioral: Enhanced Care Group; Behavioral: Remote Blood Pressure Monitoring alone

Detailed Description

The investigators will enroll 240 eligible pregnant women between 28 weeks gestation until the delivery. All participants will have a current or past history of high blood pressure during pregnancy, chronic high blood pressure, and a single-baby pregnancy.

RBPM alone program:

Participants in this group will receive an automatic blood pressure (BP) cuff and wear the cuff for 6 weeks after childbirth. Participants will be asked to measure their BP every day during the first 2 weeks after delivery and 3-5 times per week during weeks 3-6. BP readings will be sent automatically to the electronic medical record. A clinical decision support system will identify missing readings or possible care needs. A nurse will send reminders, contact participants to discuss symptoms or medications, and refer them to their primary care providers when needed. At 7 weeks after delivery, BP monitoring and text messages will stop, and BP cuffs will be collected. After the initial 6 weeks after delivery, participants in the RBPM-only group will receive weekly messages with publicly available information about heart disease risk after high blood pressure in pregnancy, healthy lifestyle tips from professional organizations, and guidance on infant development.

Enhanced Care program During the first 6 weeks after delivery, participants in the enhanced care group will receive the same RBPM program described above. Starting at 7 weeks after delivery, women whose BP was normal during the first 6 weeks will stop BP monitoring. Women whose BP remains high (above 130/80 mmHg) or who are still taking BP medications will continue monitoring their BP three times per week until 6 months after delivery. Nurses will continue to provide reminders and support.

In addition, participants in the enhanced care group will receive 10-week health coaching led by a community health worker (CHW). This will include 10 weekly coaching calls by CHW. The coaching will focus on heart-healthy lifestyle behaviors that help lower BP and improve heart health. These include healthy weight loss goals (1-3 pounds per week), better nutrition, gradually increasing physical activity, stress management, and quitting tobacco use. Participants will be reminded to watch the weekly videos (~30 min long). The CHW will screen for social needs (such as food, housing, or transportation) and connect participants to available community services. Participants will receive a personalized weight-tracking graph.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jihong Liu, Sc.D; Phone Number: 18037776854; Email: jliu@mailbox.sc.edu
• Study Contact Backup: Name: Andrew Mather, MD; Phone Number: 8034349669; Email: andrew.mather4@prismahealth.org

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • Recruiting
      • University of South Carolina
      • Contact: Jihong Liu, ScD; Phone Number: 8037776854; Email: jliu@mailbox.sc.edu
      • Sub-Investigator: Andrew Mather, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 28 weeks gestation
• A current hypertensive disorders in pregnancy or chronic hypertension
• Singletons
• Access to phone
• Plan to deliver at Prisma Health-Midlands Hospital.

Exclusion Criteria:

• Multiples
• Fetal anomaly
• Don't speak English
• Already delivered a baby greater than 14 days ago.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced Care Group; Remote blood pressure monitoring and CHW-led lifestyle program	Behavioral: Enhanced Care Group; During the first 6 weeks after delivery, participants in the enhanced care group will receive the same RBPM program described above. Starting at 7 weeks after delivery, women whose BP was normal during the first 6 weeks will stop BP monitoring. Women whose BP remains high (above 130/80 mmHg) or who are still taking BP medications will continue monitoring their BP three times per week until 6 months after delivery. Nurses will continue to provide reminders and support. In addition, participants in the enhanced care group will receive 10-week health coaching led by a community health worker (CHW). This will include 10 weekly coaching calls by CHW. The coaching will focus on heart-healthy lifestyle behaviors that help lower BP and improve heart health. These include healthy weight loss goals (1-3 pounds per week), better nutrition, gradually increasing physical activity, stress management, and quitting tobacco use. Participants will be reminded to watch the weekly v
Active Comparator: Remote Blood Pressure Monitoring alone; Remote BP monitoring alone	Behavioral: Remote Blood Pressure Monitoring alone; Participants in this group will receive an automatic blood pressure (BP) cuff and wear the cuff for 6 weeks after childbirth. Participants will be asked to measure their BP every day during the first 2 weeks after delivery and 3-5 times per week during weeks 3-6. BP readings will be sent automatically to the electronic medical record. A clinical decision support system will identify missing readings or possible care needs. A nurse will send reminders, contact participants to discuss symptoms or medications, and refer them to their primary care providers when needed. At 7 weeks after delivery, BP monitoring and text messages will stop, and BP cuffs will be collected. After the initial 6 weeks after delivery, participants in the RBPM-only group will receive weekly messages with publicly available information about heart disease risk after high blood pressure in pregnancy, healthy lifestyle tips from professional organizations, and guidance on infant development.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of Blood Pressure Control	Percentage of participants with controlled blood pressure (<130/80 mmHg). Blood pressure will be measured three times for each participant, with 60 seconds rest between each measurement using Omron HEM-780 automated monitor. The average of three measures will be used for each visit.	6 months
Change in mean systolic BP (mmHg), diastolic BP (mmHg), arterial pressure	Arterial pressure will be calculated using formula ((SBP+2DBP)/3).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change from delivery	Weight change will be calculated by substracting weight at 6 months from the delivery room weight in pounds	Weight change from delivery to 6 months postpartum
Change in intake of fiber, trans-fat, and fruit and vegetables	the 19-item PrimeScreen, a brief validated dietary survey, will be used to assessed the change in dietary quality.	6 months
Change in physical activity	SenseWear Armbands will be used to objectively measure physical activity at baseline and at 6 months postpartum. Key physical activity measures will include the number of steps per day and mins/day spent in moderate-to-vigorous physical activity.	6 months
Change in the self-efficacy score in diet	Self-efficacy for overcoming common barriers to eating a healthy diet will be assessed using the Self-Efficacy for Diet Questionnaire (Sallis JF, 1988).	6 months
Change in self-efficacy score in physical activity	Self-efficacy for overcoming common barriers to exercise will be assessed using a validated 5-item questionnaire (Marcus BH, 1992).	6 months
Numbers of participants attending emergency department visits and being readmitted into hospitals	ED visits and hospital readmissions from delivery room until 6 months postpartum will be abstracted from medical records. Changes in total ED visits and hospital readmissions will be calculated.	From delivery to 6 months postpartum

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: Prisma Health-Midlands

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2026
• Primary Completion (Estimated): July 15, 2029
• Study Completion (Estimated): July 15, 2029

Study Registration Dates

• First Submitted: January 24, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: postpartum; Cardiovascular risk; lifestyle intervention; community health worker; Blood pressure monitoring
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 2362858-1; 7355-SP (Other Identifier: The Duke Endowment)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (including baseline characteristics, outcome measures) that underlie the results reported in publications will be shared. The study protocol, statistical analysis plan, and data dictionary will also be made available.
• IPD Sharing Time Frame: Data will become available beginning 6 months following publication of the primary results and will remain available for 5 years.
• IPD Sharing Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by the study investigators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No