JMIR Publications

ABSTRACT

Background:

In the United States, mental health complications and cardiovascular events are the two leading causes of death for birthing parents in the year following delivery. The majority of these deaths are preventable, with Black and Latinx individuals experiencing higher rates of these postpartum complications. Current postpartum care has not reduced these disparities.

Objective:

This randomized controlled trial aims to train non-medical professionals in a novel intervention to prevent postpartum depressive symptoms and improve cardiovascular health following childbirth in a low-income New York City birthing population.

Methods:

We aim to recruit 600 birthing individuals over three sites across New York City. After screening and consent, participants will be randomized to the Living Healthy for Moms intervention (doula-delivered cognitive behavioral therapy and cardiovascular behavioral health intervention) or attention control (a variation of standard postpartum doula care). Daily telephone contacts for the first 7 days immediately after hospital discharge are followed by 12 doula-led video sessions conducted over 6 months. The primary outcomes are postpartum depressive symptoms and cardiovascular health, with secondary outcomes of psychosocial status, health behaviors, healthcare utilization, and patient satisfaction. All outcomes are measured via REDCap surveys administered at baseline, 2 weeks, 6 weeks, 3 months and 6 months post-discharge. Physiological measurements of hemoglobin A1c, lipids, and blood pressure will be collected at baseline, 3 months, and 6 months. Doulas, hospital staff, and birthing individuals will be recruited to evaluate the implementation of the intervention following the conclusion of recruitment at each site. A mixed methods triangulated approach will be utilized, including electronic health record data extraction, web-based surveys, key informant interviews, and focus groups.

Results:

Recruitment and data collection began at the first site in Brooklyn on January 23, 2025. As of this writing, recruitment is paused due to government interference in funding. Trial results will not be analyzed until year 7 in 2029, when recruitment has concluded, and all data have been collected from all three sites.

Conclusions:

This hybrid type 1 effectiveness-implementation randomized controlled trial will test a novel non-specialist intervention to prevent mental health and cardiovascular health complications of childbirth, culturally adapted to our local population in New York City. We expect that our findings will contribute to knowledge on the effectiveness and implementation of non-specialist postpartum interventions in low-resourced settings and the expansion of doula care in the postpartum. Clinical Trial: ClinicalTrials.gov ID NCT06666400