Back to search results

Comparing two approaches for Black maternal heart health (Change of HEART)

This study, called Change of HEART, is for Black women who are pregnant and have high blood pressure (hypertension) or obesity. It aims to reduce heart disease risks, which are a major concern for Black mothers. The study compares two approaches: COH and COH+. COH involves home blood pressure monitoring, nutrition and exercise tips via text, and anti-racism efforts. COH+ adds support from other Black women, including doula care, mental health services, and lactation support. Researchers will look at changes in your blood pressure and body weight at 6 weeks and 12 months after you give birth. The study plans to enroll 432 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 432 participants. It compares two different behavioral interventions, COH and COH+.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in blood pressure and body weight at 6 weeks and 12 months postpartum.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05499507

The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART)

Active, Not Recruiting
NAAges 18+InterventionalTreatment
Temple University
~345 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:COHCOH+

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in blood pressure at 6-weeks postpartum.
Measured over At baseline and 6-weeks postpartum
+3 more outcomes measured

Conditions

Pregnancy Related
Hypertension
Obesity
Racism

Explore related trials

HypertensionObesityPregnancy

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Sharon J Herring, MD, MPH · PRINCIPAL_INVESTIGATOR · Temple University, Philadelphia, Pennsylvania, United States, 19140

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

age ≥18 years
baseline BMI ≥30 kg/m2 and/or diagnosis of HTN (≥130/80 x 2)
gestational age ≤28 weeks by last menstrual period
smartphone ownership
self-identification as Black or African American

What this trial measures

  • Change in blood pressure at 6-weeks postpartum.At baseline and 6-weeks postpartum

    Blood pressure will be measured at each time point on the upper arm three times at one-minute intervals after five minutes of quiet sitting. The investigators will use the validated Omron HEM-907XL and the appropriate size cuff. The investigators will average the three measures for analysis.

  • Change in blood pressure at 12-months postpartum.At baseline and 12-months postpartum

    Blood pressure will be measured at each time point on the upper arm three times at one-minute intervals after five minutes of quiet sitting. The investigators will use the validated Omron HEM-907XL and the appropriate size cuff. The investigators will average the three measures for analysis.

  • Change in body weight at 6-weeks postpartum.At baseline and 6-weeks postpartum

    Body weight will be measured in duplicate and recorded to the nearest 0.1kg using calibrated SECA scales at each time point.

  • Change in body weight at 12-months postpartum.At baseline and 12-months postpartum

    Body weight will be measured in duplicate and recorded to the nearest 0.1kg using calibrated SECA scales at each time point.