Living Healthy for Moms RCT (LHMoms)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiac Event; Postpartum Depression (PPD)
• Intervention / Treatment: Other: No intervention; Behavioral: LHMoms Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11215
      • New York Presbyterian Brooklyn Methodist Hospital
    • Jamaica, New York, United States, 11432
      • New York City Health + Hospitals/ Queens
    • New York, New York, United States, 10065
      • Weill Cornell Medicine
    • New York, New York, United States, 10034
      • NewYork-Presbyterian Allen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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 Names: LHM Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Postnatal Depression Scale (EPDS) score	The primary outcome of PPD, operationalized as the presence or absence of postpartum depressive symptoms, is defined by EPDS score (≥9). EPDS ≥9 was chosen specifically because that is the score used as the cut-off to refer for clinical evaluation, and the rate of EPDS ≥9 ranges from about 30-40% depending on other characteristics of the clinics. Assuming 1:1 randomization, a design effect of 1.5 to account for variance among sites and doulas, a power of 0.80, a two-sided significance level of 0.05, and 20-25% attrition, to detect a PPD symptom rate reduction from 33.5% in the control arm to 23% in the intervention, a sample size of approximately 450 individuals (225 in each study arm) is needed. The EPDS scale ranges from 0 to 30, and a higher score indicates more severe depression.	6 months post hospital discharge
Heart Score	The "Heart Score" is a metric calculated through the American Heart Association's online calculator. It incorporates the behavioral and biological components Life's Essential 8 (LE8) (diet, physical activity, nicotine exposure, sleep health, body mass index, blood lipids, blood glucose, and blood pressure). These components will be collected from participants during the study but are not being assessed as individual outcomes; instead, the Heart Score from 1-100 as calculated by the AHA online calculator will be used as the outcome of CV health.	6 months post hospital discharge

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Weill Medical College of Cornell University; New York City Health and Hospitals Corporation; Northern Manhattan Perinatal Partnership; Caribbean Women's Health Association
• Investigators: Principal Investigator: Mary E. D'Alton, MD, Columbia University

Publications and helpful links

General Publications

• Faiz JM, Bylinsky I, Rincones Rojas L, Kopatsis K, St Clair V, Dorval-Moller M, Voegtline K, Lipkind H, Safford MM, Hall KS, Reddy U, Osborne LM. Doula-Delivered Cognitive Behavioral Training and Cardiovascular Health Intervention for Birthing Individuals in a Low-Income New York City Population: Protocol for a Living Healthy for Moms Randomized Type I Hybrid Effectiveness-Implementation Trial. JMIR Res Protoc. 2025 Dec 10;14:e76871. doi: 10.2196/76871.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: mental health; cardiovascular events; health disparity; maternal welfare; maternal mortality; severe maternal morbidity; structural racism
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Death; Mood Disorders; Puerperal Disorders; Depressive Disorder; Parental Death; Pathological Conditions, Signs and Symptoms; Behavior; Personal Satisfaction; Social Behavior; Prejudice; Social Discrimination; Racism; Cardiovascular Diseases; Depression, Postpartum; Maternal Death; Psychological Well-Being; Systemic Racism
• Other Study ID Numbers: AAAV1436; 5U54HD113172-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No