The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTemple University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
COH
BehavioralIncorporates 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+
BehavioralIncludes all components of COH plus interpersonal support for Black women by Black women (community doula care, mental health services, and lactation support).
Treatment groups
432 Participants
are divided into 2 treatment groupsGroup A: Change of Heart (COH)Active comparator 1 intervention
Group B: Change of Heart Plus (COH+)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At baseline and 6-weeks postpartum2
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.
Time frame
At baseline and 12-months postpartum3
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.
Time frame
At baseline and 6-weeks postpartum4
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.
Time frame
At baseline and 12-months postpartumSecondary outcomes
1
Change in emotional support at 6-weeks postpartum.
The investigators will use the 8-item emotional support PROMIS instrument to measure perceived feelings of being cared for at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater emotional support.
Time frame
At baseline and 6-weeks postpartum2
Change in emotional support at 12-months postpartum.
The investigators will use the 8-item emotional support PROMIS instrument to measure perceived feelings of being cared for at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater emotional support.
Time frame
At baseline and 12-months postpartum3
Change in informational support at 6-weeks postpartum.
The investigators will use the 8-item informational support PROMIS instruments to measure perceived availability of helpful information or advice at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater informational support.
Time frame
At baseline and 6-weeks postpartum4
Change in informational support at 12-months postpartum.
The investigators will use the 8-item informational support PROMIS instruments to measure perceived availability of helpful information or advice at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater informational support.
Time frame
At baseline and 12-months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Temple University
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov