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

NCT07457970 | Recruiting

• 2 other identifiers: 2362858-17355-SP
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension (HTN); Pregnancy; Blood Pressure Monitoring

Keywords

community health worker; lifestyle intervention; Blood pressure monitoring; postpartum; Cardiovascular risk

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Weight change from delivery

  Weight change from delivery to 6 months postpartum

• Change in intake of fiber, trans-fat, and fruit and vegetables

  6 months

• Change in physical activity

  6 months

• Change in the self-efficacy score in diet

  6 months

• Change in self-efficacy score in physical activity

  6 months

Study Arms (2)

Enhanced Care Group

EXPERIMENTAL

Remote blood pressure monitoring and CHW-led lifestyle program

Behavioral: Enhanced Care Group

Remote Blood Pressure Monitoring alone

ACTIVE COMPARATOR

Remote BP monitoring alone

Behavioral: Remote Blood Pressure Monitoring alone

Interventions

Enhanced Care Group BEHAVIORAL

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

Enhanced Care Group

Remote Blood Pressure Monitoring alone BEHAVIORAL

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.

Remote Blood Pressure Monitoring alone

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of South Carolina: lead
• Prisma Health-Midlands: collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jihong Liu, Sc.D

CONTACT

18037776854; jliu@mailbox.sc.edu

Andrew Mather, MD

CONTACT

8034349669; andrew.mather4@prismahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: March 9, 2026
• Study Start: April 24, 2026
• Primary Completion (Estimated): July 15, 2029
• Study Completion (Estimated): July 15, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available beginning 6 months following publication of the primary results and will remain available for 5 years.
• 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.

Locations

US (1)