Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05499507

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexFemale

Healthy volunteersAccepted

ConditionPregnancy Related, Hypertension, Obesity, Racism

Full registry criteria

Inclusion Criteria: * 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

Treatments and study arms

COH

Behavioral

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).

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).

Primary outcomes

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

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Temple University/Temple Health🇺🇸 Philadelphia, Pennsylvania, United States

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