Living Healthy for Moms RCT

NAActive, not recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

January 17, 2025

Primary Completion Date

June 1, 2030

Study Completion Date

June 1, 2030

Conditions
Postpartum Depression (PPD)Cardiac Event
Interventions
BEHAVIORAL

LHMoms Intervention

The LHM arm (N=300) will receive a CBT+ Cardiovascular Health (CVH) Intervention to reduce CV risk. LHM employs a (CBT) + cardiovascular health (CVH) intervention delivered by doulas and integrating a healthy lifestyle intervention to reduce CV risk. The LHM intervention integrates the following key elements: (1) doula-led emergency detection in the first 7 days post-discharge; (2) home BP monitoring (HBPM); and (3) 12-sessions of the doula-delivered intervention to prevent PPD and reduce CV risk from 1 week to 6 months post-discharge, supported by (4) education through the Patient-Activated Learning System (PALS), a novel education platform used to engage low-literacy, racially marginalized individuals. LHM is based on the Thinking Healthy Programme (THP), an intervention originally designed to treat PPD in low and middle-income countries using community health workers.

OTHER

No intervention

Standard doula care and the same number of telephone or video-delivered sessions and will last the same amount of time on general postpartum health topics not related to CV health or depression. Attention control participants will not receive doula-initiated outreach during the first 7 days.

Trial Locations (4)

10034

NewYork-Presbyterian Allen Hospital, New York

10065

Weill Cornell Medicine, New York

11215

New York Presbyterian Brooklyn Methodist Hospital, Brooklyn

11432

New York City Health + Hospitals/ Queens, Jamaica

Sponsors
All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

Weill Medical College of Cornell University

OTHER

collaborator

Northern Manhattan Perinatal Partnership

OTHER

collaborator

New York City Health and Hospitals Corporation

OTHER

collaborator

Caribbean Women's Health Association

UNKNOWN

lead

Columbia University

OTHER

NCT06666400 - Living Healthy for Moms RCT | Biotech Hunter | Biotech Hunter