Clinical trial NCT06666400: Living Healthy for Moms RCT
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postpartum Depression (PPD)
Cardiac Event
Keywords: severe maternal morbidity
maternal mortality
mental health
cardiovascular events
health disparity
maternal welfare
structural racism
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Weill Medical College of Cornell University
name: Northern Manhattan Perinatal Partnership
name: New York City Health and Hospitals Corporation
name: Caribbean Women's Health Association
First posted: 2024-10-30
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS) score
timeFrame: 6 months post hospital discharge
measure: Heart Score
timeFrame: 6 months post hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: New York Presbyterian Brooklyn Methodist Hospital
state: New York
city: Jamaica
country: United States
facility: New York City Health + Hospitals/ Queens
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian Allen Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Columbia University
name: Uma Reddy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: