LHMomsDoula-Delivered Cognitive Behavioral Training for Postpartum Health in NYC
LHMoms Intervention
+ No intervention
Urogenital Diseases+19
+ Systemic Racism
+ Psychological Well-Being
Prevention Study
Summary
Study start date: January 17, 2025
Actual date on which the first participant was enrolled.This study aims to address the high rates of preventable complications and deaths in mothers during and after childbirth, focusing on both mental health conditions and heart-related issues. The study specifically targets birthing individuals in New York City, where the risk is notably higher for Black mothers compared to White mothers. Current community programs often lack a comprehensive approach, focusing mostly on basic needs. The study introduces the "Living Healthy for Moms" program, which is a holistic care intervention designed to support mothers from the time they leave the hospital up to six months postpartum. It includes empowerment education, early detection of health emergencies, and cognitive behavioral training led by doulas to help reduce postpartum depression and heart health risks. Participants in this study will be randomly chosen and grouped to either receive the "Living Healthy for Moms" program or standard care. The program involves doulas providing education and support both in the hospital and at home, focusing on detecting health issues early on and offering cognitive behavioral training to help with mental and heart health. Researchers will assess the program's success by looking at improvements in postpartum depression and heart health, as well as changes in how often participants use healthcare services and their satisfaction with the care received. This trial takes place in Brooklyn, Queens, and Northern Manhattan, aiming to enhance postpartum outcomes for historically disadvantaged mothers by adapting the intervention to each community's needs.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.21 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, United StatesNew York City Health + Hospitals/ Queens
Jamaica, United StatesNewYork-Presbyterian Allen Hospital
New York, United States