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ACTIVE NOT RECRUITING
NCT06666400
NA

Living Healthy for Moms RCT

Sponsor: Columbia University

View on ClinicalTrials.gov

Summary

LHMoms is a novel integrated care intervention that focuses intensively on care continuity and community-to-healthcare linkages for postpartum birthing individuals. The intervention starts prior to discharge in the delivery hospitalization and extends to six months post-partum, thus covering critical windows to prevent long-term physical and mental health sequelae.

Official title: Living Healthy for Moms (LHM) Randomized Type I Hybrid EffectivenessImplementation Trial: A Doula-Delivered Cognitive Behavioral Training (CBT) + Cardiovascular Health (CVH) Intervention for Birthing Individuals

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2025-01-17

Completion Date

2030-06-01

Last Updated

2026-01-14

Healthy Volunteers

No

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.

Locations (4)

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States

New York City Health + Hospitals/ Queens

Jamaica, New York, United States

NewYork-Presbyterian Allen Hospital

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States