Living Healthy for Moms RCT

NCT06666400 | Active Not Recruiting DMC

• 2 other identifiers: AAAV14365U54HD113172-02
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

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.

Conditions

Cardiac Event; Postpartum Depression (PPD)

Keywords

severe maternal morbidity; maternal mortality; mental health; cardiovascular events; health disparity; maternal welfare; structural racism

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Attention Control

ACTIVE COMPARATOR

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

LHMoms Intervention Arm

EXPERIMENTAL

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

Interventions

LHMoms Intervention 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.

Also known as: LHM Arm

LHMoms Intervention Arm

No intervention 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.

Attention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Weill Medical College of Cornell University: collaborator
• Northern Manhattan Perinatal Partnership: collaborator
• New York City Health and Hospitals Corporation: collaborator
• Caribbean Women's Health Association: collaborator

Study Sites (4)

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

New York City Health + Hospitals/ Queens

Jamaica, New York, 11432, United States

Location

NewYork-Presbyterian Allen Hospital

New York, New York, 10034, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 41370009 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Cardiovascular Diseases; Maternal Death; Psychological Well-Being; Systemic Racism

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior; Racism; Prejudice; Social Behavior; Social Discrimination

Study Officials

• Mary E. D'Alton, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the Department of Obstetrics and Gynecology

Model Details: 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.

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 30, 2024
• Study Start: January 17, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (4)