Living Healthy for Moms RCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-17

Study Completion Date

2030-06-01

Brief Summary

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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.

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Detailed Description

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Most preventable maternal deaths occur in the intrapartum and immediate postpartum (PP) periods, as do complications from undetected/undertreated mental health (MH) conditions (e.g., suicide, overdose) and cardiovascular (CV) events. In New York City (NYC), maternal deaths are 8-12 times higher for Black than for White birthing parents. However, most community-based programs addressing the health of birthing individuals in this population have been narrowly focused on basic services (e.g., breastfeeding, social support), with limited focus on evidence-based care. Holistic interventions addressing physical, mental, and social health needs in the critical PP transition and moving from trauma- and "risk"-based to a strength- and empowerment-based approach are urgently needed. Many hospital, community, and governmental barriers preclude broad adoption and scaling of doula-delivered care, and it is not known how facilitators, assets, and resources can improve care continuity and community-hospital linkages to support birthing individuals at diverse sites across NYC. The impact of doula-led interventions at patient- and health-system levels have yet to be rigorously evaluated. In collaboration with the Caribbean Women's Health Association and the Northern Manhattan Perinatal Partnership, this study will address these gaps by implementing and evaluating Living Healthy for Moms (LHMoms) in three complementary settings and populations (Brooklyn, Queens, and Northern Manhattan). LHMoms is a novel integrated care intervention that focuses intensively on care continuity and community-to-healthcare linkages that starts prior to discharge and during the first 7 days post-discharge (PD) and extends into six months post-partum, as critical windows to prevent long-term physical and mental health sequelae, while also addressing key determinants of lifelong health risk. The investigators have developed several innovative, evidence-based interventions, including an online education empowerment program (using a Patient Activated Learning System platform we developed) to build patient self-advocacy beginning in-hospital; a doula-led health emergency detection program during the critical first 7 days PD; and a trauma-informed doula-delivered cognitive behavioral training (CBT) intervention to address PP depression and cardiovascular risks for the critical six months following delivery. This study proposes a rigorous, mixed-methods study of LHMoms to address three specific aims. In Aim 1, the study will test the effectiveness of LHMoms vs. attention control in a Hybrid Type 1 Implementation Trial with 600 randomized birthing individuals at three hospital sites in Brooklyn, Queens, and Northern Manhattan. This will include refining and tailoring the intervention to each site to maximize care quality, building capacity for doulas to deliver LHMoms, and assessing effectiveness in lowering PP depression, improving CV health. In Aim 2, the study will analyze the effects of LHMoms on PP healthcare utilization and satisfaction. In Aim 3, the study will examine the implementation process and outcomes of the LHMoms intervention at the three sites. This project will advance the overall goals of NY-CHAMP to optimize PP outcomes for historically disadvantaged birthing individuals.

Conditions

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Postpartum Depression (PPD) Cardiac Event

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This randomized type 1 Hybrid Effectiveness-Implementation Trial will enroll 600 birthing individuals post-delivery, while they are still in the hospital, pre-discharge. These individuals will be randomized to one of two groups: the LHM arm (N=300) will receive a CBT+ Cardiovascular Health (CVH) Intervention to reduce CV risk, and the attention control arm (N=300) will receive standard doula care and the same number of telephone or video call-delivered sessions on general health education topics not related to CV health or depression.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Attention Control

The attention control arm (N=300) will receive 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.

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type OTHER

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.

LHMoms Intervention Arm

The LHM arm (N=300) will receive a CBT+ Cardiovascular Health (CVH) Intervention to reduce CV risk. LHM employs a cognitive behavioral training (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) 11-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.

Group Type EXPERIMENTAL

LHMoms Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Other Intervention Names

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LHM Arm

Eligibility Criteria

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Inclusion Criteria

* Birthing individuals aged 18 years or older
* Delivery of singleton live birth; and
* Minority race (self-identified Black), minority ethnicity (self-identified Latinx), and/or Medicaid beneficiary.

Exclusion Criteria

* Individuals unable to conduct visits and complete surveys via computer or phone,
* Younger than 18 years
* Individuals unable to communicate (reading, writing, speaking) in English, Spanish or Haitian Creole
* multifetal pregnancy
* gestational age less than 24 weeks at delivery
* known major fetal anomaly in current pregnancy
* known fetal demise
* on hemodialysis
* active user of IV drugs
* active suicidal ideation with intent and plan
* known primary psychotic disorder
* plans to move out of the area within 6 months

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No