Integrated care program for postpartum individuals
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
NA · Columbia University · NCT06666400
This study is testing a new program that provides support and resources for Black and Latinx moms after childbirth to see if it helps improve their health and reduce serious complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Columbia University (other) |
| Locations | 4 sites (Brooklyn, New York and 3 other locations) |
| Trial ID | NCT06666400 on ClinicalTrials.gov |
What this trial studies
The Living Healthy for Moms program is an innovative intervention designed to enhance care continuity and link postpartum birthing individuals to community resources. It begins during the hospital stay and continues for six months after delivery, addressing both mental health and cardiovascular risks. The program specifically targets Black and Latinx individuals, aiming to reduce severe maternal morbidity and mortality rates in these populations. By collaborating with local health organizations, the study seeks to evaluate the effectiveness of doula-led care in improving health outcomes during the critical postpartum period.
Who should consider this trial
Good fit: Ideal candidates for this program are birthing individuals aged 18 and older who identify as Black or Latinx and are Medicaid beneficiaries.
Not a fit: Patients who may not benefit include those with active suicidal ideation, major psychotic disorders, or those unable to participate in the program due to language barriers or technological limitations.
Why it matters
Potential benefit: If successful, this program could significantly reduce postpartum depression and cardiac events among birthing individuals, particularly in underserved communities.
How similar studies have performed: While similar community-based interventions have been implemented, the specific doula-led approach and its rigorous evaluation in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brooklyn, New York and 3 other locations
- New York Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States (RECRUITING)
- New York City Health + Hospitals/ Queens — Jamaica, New York, United States (NOT_YET_RECRUITING)
- NewYork-Presbyterian Allen Hospital — New York, New York, United States (NOT_YET_RECRUITING)
- Weill Cornell Medicine — New York, New York, United States (ACTIVE_NOT_RECRUITING)
Study contacts
- Principal investigator: Uma Reddy, MD, MPH — Columbia University
- Study coordinator: Uma Reddy, MD,MPH
- Email: ur2137@cumc.columbia.edu
- Phone: 212-305-6293
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postpartum Depression, Cardiac Event, severe maternal morbidity, maternal mortality, mental health, cardiovascular events, health disparity, maternal welfare