Living Healthy for Moms RCT
Key facts
- Who runs it
- Columbia University
- Where
- Brooklyn, Jamaica, and New York, United StatesSee the 4 sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 21 people enrolled
- Started
- 17 Jan 2025
- Expected to end
- 1 Jun 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- LHMoms Intervention
- Record updated
- 14 January 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- active user of IV drugs
- known primary psychotic disorder
- Younger than 18 years
- gestational age less than 24 weeks at delivery
- Individuals unable to conduct visits and complete surveys via computer or phone,
- Individuals unable to communicate (reading, writing, speaking) in English, Spanish or Haitian Creole
- multifetal pregnancy
- known major fetal anomaly in current pregnancy
- known fetal demise
- on hemodialysis
- active suicidal ideation with intent and plan
- plans to move out of the area within 6 months
Where in United States
- New York-Presbyterian/Brooklyn Methodist HospitalBrooklyn, United States
- New York City Health + Hospitals/ QueensJamaica, United States
- NewYork-Presbyterian Allen HospitalNew York, United States
- Weill Cornell MedicineNew York, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Attention ControlExisting treatment, for comparison
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.
- LHMoms Intervention ArmTreatment being tested
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.
Treatment: LHMoms Intervention
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Publications
- Record updated
- 14 January 2026