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Heart Health Interventions for Black Maternal Health

N/A

Recruiting

Led By Sharon J Herring, MD, MPH

Research Sponsored by Temple University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Baseline BMI ≥30 kg/m2 and/or diagnosis of HTN (≥130/80 x 2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-months postpartum

Awards & highlights

Study Summary

This trial aims to reduce heart disease risk factors in Black women, using community-led strategies. #hearthealth #BlackWomenMatter

Who is the study for?

This trial is for Black or African American women over 18 years old who are less than 24 weeks pregnant, have a BMI of 30 or more and/or high blood pressure. Participants must own a smartphone to join.Check my eligibility

What is being tested?

The study compares two interventions aimed at reducing heart disease risk in perinatal Black women: COH and an enhanced version, COH+. It's community-driven, focusing on overcoming health disparities.See study design

What are the potential side effects?

Since the interventions involve lifestyle changes rather than medications, side effects may include typical reactions to new exercise routines or diets such as muscle soreness or dietary adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

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I have a BMI of 30 or higher and/or high blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in blood pressure at 12-months postpartum.

Change in blood pressure at 6-weeks postpartum.

Change in body weight at 12-months postpartum.

+1 more

Secondary outcome measures

Blood pressure change at 1 week postpartum.

Blood pressure change at 12 weeks postpartum.

Blood pressure change at 32-34 weeks gestation.

+23 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Change of Heart Plus (COH+)Experimental Treatment1 Intervention

Includes all components of COH plus the addition of interpersonal support for Black women by Black women (community doula care, mental health services, and lactation support).

Group II: Change of Heart (COH)Active Control1 Intervention

Incorporates two, evidence-based individual-level interventions (home blood pressure telemonitoring coupled with the interactive obesity treatment approach, that includes nutrition and physical activity text messages with tailored feedback) and an institutional-level intervention (anti-racism training of providers and staff along with patient feedback to inform respectful care).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER

550 Previous Clinical Trials

29,996,516 Total Patients Enrolled

1 Trials studying Racism

30,000 Patients Enrolled for Racism

Temple UniversityLead Sponsor

297 Previous Clinical Trials

82,541 Total Patients Enrolled

Sharon J Herring, MD, MPHPrincipal InvestigatorTemple University, Philadelphia, Pennsylvania, United States, 19140

2 Previous Clinical Trials

678 Total Patients Enrolled

Media Library

COH Clinical Trial Eligibility Overview. Trial Name: NCT05499507 — N/A

Racism Research Study Groups: Change of Heart Plus (COH+), Change of Heart (COH)

Racism Clinical Trial 2023: COH Highlights & Side Effects. Trial Name: NCT05499507 — N/A

COH 2023 Treatment Timeline for Medical Study. Trial Name: NCT05499507 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team presently welcoming volunteers for this experiment?

"This medical research project is actively recruiting patients according to the information found on clinicaltrials.gov. The initial posting date was January 19th, 2023 and it has been edited most recently on January 10th, 2023."

Answered by AI

How many participants are currently signed up for this research study?

"Affirmative. Clinicaltrials.gov reveals that this medical research is currently accepting participants, with the initial posting date being January 19th 2023 and the most recent update taking place on January 10th 2023. The study seeks to recruit 432 patients from a single site."

Answered by AI

What aims is this clinical trial attempting to achieve?

"Primarily, the investigators will assess Change in body weight at 12-months postpartum over a 6 week interval. Secondary objectives include gauging participants' emotional and informational support via PROMIS instruments - with higher scores indicating greater perceived levels of both."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05499507.