Recruiting

RBPM & Lifestyle Program

Sponsor:

University of South Carolina

Code:

NCT07457970

Conditions

Blood Pressure Monitoring

Hypertension (HTN)

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enhanced Care Group

Remote Blood Pressure Monitoring alone

Study Details

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

Blood Pressure Monitoring

Hypertension (HTN)

Pregnancy

Study ID

NCT07457970

Start date

Apr 24, 2026

Status verified date

Apr, 2026

Completion date

Jul 15, 2029

Anticipated

Primary completion date

Jul 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Enhanced Care Group

Remote blood pressure monitoring and CHW-led lifestyle program

active comparator: Remote Blood Pressure Monitoring alone

Remote BP monitoring alone

Interventions

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

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.

Primary outcome measure

  • Rates of Blood Pressure Control [ Time Frame: 6 months ]
  • Change in mean systolic BP (mmHg), diastolic BP (mmHg), arterial pressure [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Jihong Liu, Sc.D

18037776854jliu@mailbox.sc.edu

Andrew Mather, MD

8034349669andrew.mather4@prismahealth.org

Locations

University of South Carolina

Recruiting

Columbia, South Carolina, United States, 29208

Contacts

Jihong Liu, ScD

8037776854jliu@mailbox.sc.edu

More Information

Sponsor

University of South Carolina

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Carolina on 2026-05-04.