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

NCT05499507 | Recruiting

• 1 other identifier: 27919
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of our proposal is to reduce disparities in perinatal cardiovascular disease risk factors among Black women utilizing a community-driven, social ecological framework.

Conditions

Pregnancy Related; Hypertension; Obesity; Racism

Outcome Measures

Primary Outcomes (4)

• Change in blood pressure at 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.

  At baseline and 6-weeks postpartum

• Change in blood pressure at 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.

  At baseline and 12-months postpartum

• Change in body weight at 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.

  At baseline and 6-weeks postpartum

• Change in body weight at 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.

  At baseline and 12-months postpartum

Secondary Outcomes (23)

• Change in emotional support at 6-weeks postpartum.

  At baseline and 6-weeks postpartum

• Change in emotional support at 12-months postpartum.

  At baseline and 12-months postpartum

• Change in informational support at 6-weeks postpartum.

  At baseline and 6-weeks postpartum

• Change in informational support at 12-months postpartum.

  At baseline and 12-months postpartum

• Change in Perinatal Mood and Anxiety Disorders (PMADs) at 6-weeks postpartum.

  At baseline and 6-weeks postpartum

Study Arms (2)

Change of Heart (COH)

ACTIVE COMPARATOR

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).

Behavioral: COH

Change of Heart Plus (COH+)

EXPERIMENTAL

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).

Behavioral: COH+

Interventions

COH+ BEHAVIORAL

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

Change of Heart Plus (COH+)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years
• baseline BMI ≥30 kg/m2 and/or diagnosis of HTN (≥130/80 x 2)
• gestational age \<24 weeks by last menstrual period
• smartphone ownership
• self-identification as Black or African American

Sponsors & Collaborators

• Temple University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Temple University/Temple Health

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Related Publications (1)

• Wycoff KL, Coleman JG, Santoro CM, Zullig LL, Darden N, Holland PM, Cruice JF, Mitchell S, Smith M, McNeil SJ, Herring SJ. Multilevel Community Engagement to Inform a Randomized Clinical Trial. Obstet Gynecol. 2023 Oct 1;142(4):929-939. doi: 10.1097/AOG.0000000000005344. Epub 2023 Sep 7.

  PMID: 37734093 DERIVED

MeSH Terms

Conditions

Hypertension; Obesity; Racism

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prejudice; Social Behavior; Behavior; Social Discrimination

Study Officials

• Sharon J Herring, MD, MPH

  Temple University, Philadelphia, Pennsylvania, United States, 19140

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon J Herring, MD, MPH

CONTACT

2157072234; sharon.herring@temple.edu

Christine Santoro, CPM, MA

CONTACT

christy.santoro@temple.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: August 12, 2022
• Study Start: January 24, 2023
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): December 10, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: 8/10/2027

Locations

US (1)