Thriving Hearts Program for High Blood Pressure During Pregnancy

Overseen By Quintana Stewart, MPA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Age, Location, Language, others

Compensation: Varies

Number of Visits: Unknown

17500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The overarching goal of Thriving Hearts is to implement a multi-level program through Local Health Departments (LHDs) that cultivates conditions for mothers and birthing people to not only survive pregnancy, but to thrive. Thriving Hearts is a collaboration among LHDs in ten North Carolina counties, designed to reduce incidence of Hypertensive Disorders of Pregnancy (HDP) and their complications through support and connection at the individual, healthcare provider, and community level. The investigators will conduct a pragmatic, stepped-wedge, cluster randomized study. Participating LHDs will begin in a usual care phase, and they will transition to Thriving Hearts in clusters in a randomly assigned sequence at 9-month intervals.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators or your healthcare provider for guidance.

How does the Thriving Hearts treatment for high blood pressure during pregnancy differ from other treatments?

The Thriving Hearts treatment is unique because it focuses on lifestyle interventions, such as diet and physical activity, to manage high blood pressure during pregnancy, which is different from traditional drug-based treatments. This approach is particularly novel as it aims to reduce long-term cardiovascular risks associated with hypertensive disorders of pregnancy. ^{1 2 3 4 5}

What data supports the effectiveness of the Thriving Hearts treatment for high blood pressure during pregnancy?

The Heart Health 4 Moms (HH4M) program, which is similar to the Thriving Hearts treatment, showed that women with recent preeclampsia who participated in the program had better knowledge of heart disease risk factors, felt more confident about eating healthily, and were less physically inactive compared to those who did not participate. ^{4 6 7 8 9}

Who Is on the Research Team?

Alison M Stuebe, MD, MSc

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for pregnant individuals or those giving birth who are at risk of high blood pressure disorders like preeclampsia. Participants will be from ten North Carolina counties and must receive care through Local Health Departments involved in the study.

Inclusion Criteria

Individual who is pregnant or ≤4 months postpartum and resides in a county where Thriving Hearts is active can engage with Thriving Hearts-supported programs and services

I can communicate in English or Spanish.

Had a live birth at ≥24 weeks in the past 6 months

Exclusion Criteria

I am younger than 15 or older than 55.

Residential address not listed on birth certificate as one of the study counties

I cannot communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usual Care Phase

Participating LHDs provide usual care before transitioning to the Thriving Hearts program

9 months

Intervention Phase

Implementation of the Thriving Hearts program, including point-of-care HDP prevention and enhanced support

9 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Thriving Hearts

Trial Overview The Thriving Hearts program aims to reduce pregnancy-related high blood pressure complications by providing enhanced support at individual, healthcare provider, and community levels. It's a stepped-wedge, cluster randomized study comparing usual care with the Thriving Hearts intervention.

How Is the Trial Designed?

Group I: Post-intervention Active Control 1 Intervention

In the post-intervention sequence(s), pregnant and parenting people in participating counties will experience care enhanced with Thriving Hearts components, including point-of-care HDP prevention, health care providers equipped with resources for coping with secondary trauma, and proactive provision of social and material support.

Group II: Pre-intervention Placebo Group 1 Intervention

In the pre-intervention sequence(s), pregnant and parenting people in participating counties will experience treatment-as-usual.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Piedmont Health Services, Inc.

Collaborator

Trials

1

Recruited

17,500+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

The North Carolina Alliance of Public Health Agencies, Inc.

Collaborator

Trials

1

Recruited

17,500+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Orange County Health Department

Collaborator

Trials

1

Recruited

17,500+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Jacaranda Health

Collaborator

Trials

4

Recruited

32,800+

Published Research Related to This Trial

The BUMP trial is developing self-monitoring interventions for pregnant women to help detect high blood pressure early, which is crucial for preventing complications like pre-eclampsia.

Through qualitative research, the study identified key challenges women face in adhering to self-monitoring, leading to tailored strategies that enhance engagement and explain the benefits of monitoring, ultimately aiming to improve maternal and fetal health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention planning and modification of the BUMP intervention: a digital intervention for the early detection of raised blood pressure in pregnancy. Band, R., Hinton, L., Tucker, KL., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Intervention planning and modification of the BUMP intervention: a digital intervention for the early detection of raised blood pressure in pregnancy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized Trial to Reduce Cardiovascular Risk in Women with Recent Preeclampsia. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular risk factors one year after a hypertensive disorder of pregnancy. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Blood pressure postpartum (BP2) RCT protocol: Follow-up and lifestyle behaviour change strategies in the first 12 months after hypertensive pregnancy. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Speckle Tracking Echocardiography in Hypertensive Pregnancy Disorders: A Systematic Review. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Postpartum Interventions to Reduce Long-Term Cardiovascular Disease Risk in Women After Hypertensive Disorders of Pregnancy: A Systematic Review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Hypertensive disorders of pregnancy and long-term cardiovascular health: FIGO Best Practice Advice. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Experiences with an integrated screening programme targeted at women who had a hypertensive disorder or diabetes in pregnancy in the Netherlands: a qualitative study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Study protocol for the sheMATTERS study (iMproving cArdiovascular healTh in new moThERS): a randomized behavioral trial assessing the effect of a self-efficacy enhancing breastfeeding intervention on postpartum blood pressure and breastfeeding continuation in women with hypertensive disorders of pregnancy. [2023]