NCT06923371 · Columbia University
Moms and Babies Health and Well-being
(MBHW)
What this study is about
The goal of this clinical trial is to see how giving direct cash support affects the health of pregnant women and their babies in the U.S. Many families, especially those with low incomes, face challenges during pregnancy and after childbirth. This study will explore whether financial help during these times leads to better health.
View original scientific description
The goal of this clinical trial is to see how giving direct cash support affects the health of pregnant women and their babies in the U.S. Many families, especially those with low incomes, face challenges during pregnancy and after childbirth. This study will explore whether financial help during these times leads to better health. The main questions this research aims to answer are: * Does extra money during pregnancy and a baby's first months improve the baby's growth and overall health? * How does financial support affect a mother's physical and mental health before and after birth? * Does having extra money help moms get better healthcare and make healthier food choices for themselves and their babies? Participants in this study will be randomly assigned to either a high cash or low cash group. They will be enrolled in the study and asked to complete: * A baseline survey * A follow-up survey 12 months after enrollment * A final survey 18 months after enrollment In addition, participants' medical records will be reviewed, and some may be selected for a qualitative interview to share more about their experiences. This research is being done in partnership with The Bridge Project, a program that helps moms in need. The goal is to find better ways to support the health of moms and babies facing financial hardship.
Interventions
BEHAVIORAL
Direct Cash Support for Maternal and Infant Health (High fee)
The high fee group will receive direct cash assistance to pregnant women and mothers of infants to improve access to healthcare, alleviate financial strain, and facilitate healthier lifestyle choices. This group will receive a higher level of financial support compared to the low fee group, with the aim of examining how larger amounts of financial assistance affect maternal and infant health, healthcare access, and well-being.
BEHAVIORAL
Behavioral: Direct Cash Support for Maternal and Infant Health (Low fee)
The low fee group will receive direct cash assistance to pregnant women and mothers of infants to improve access to healthcare, reduce financial strain, and support healthier lifestyle choices. This group will receive a lower level of financial support compared to the high fee group, allowing us to compare the effects of varying levels of financial assistance on maternal and infant health outcomes.
Primary outcome measures
Number of Preterm Babies
Time frame: Immediately after birth
Preterm birth is defined as a birth that occurs before 37 completed weeks of gestation. This outcome will assess the number of preterm births within the study population as documented in medical records.
Number of babies with low birth weight
Time frame: Immediately after birth
Low birth weight is defined as an infant born weighing less than 2,500 grams (approximately 5.5 pounds) at birth. This measure will assess the number of infants in the study who meet this criteria, as low birth weight is associated with increased risks of health complications for the newborn, such as developmental delays, respiratory issues, and long-term health challenges. Weight collected at time of birth as documented in medical records.
Score on Edinburgh Postnatal Depression Scale (EPDS) - Mothers Mental Health
Time frame: Baseline, 12 months, 18 months
The EPDS is a 10-item self-reported questionnaire designed to screen for symptoms of postnatal depression. Scores range from 0 to 30, with higher scores indicating greater depressive symptoms.
Number of Babies Admitted to the NICU
Time frame: Immediately after birth
This outcome will assess the number of infants requiring admission to the Neonatal Intensive Care Unit (NICU) after birth. Collected at birth, based on the number of babies admitted to the NICU as documented in medical records.
Gestational Age
Time frame: Immediately after birth
The mean gestational ages of the infants will be calculated. Gestational age refers to the length of time a baby has been in the womb, typically measured in weeks from the first day of the mother's last menstrual period (LMP) to the date of delivery. Gestational age will be collected at birth as documented in medical records.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for treatment and control
- Living in any of the study sites: Appalachian regions (West Virginia, Ohio, Kentucky, Tennessee)
- Being in the first or second trimester
- Being 18 years or older
Exclusion criteria
- Mothers with severe conditions such as terminal cancer.
- Mothers with identified addiction disorders. This includes any current or past addiction to legal (pain medication, alcohol) or illegal substance that has known risk for self-harm death (suicide, overdose) and/or consequences for maternal and/or fetal health.
- Mothers younger than 18 years old.
- Not living in the study site range
- Mothers incarcerated during the course of the study
- Mothers institutionalized during the course of the study. Additional Notes:
- Participants who are not eligible for this study are also excluded from enrolling in the Bridge Project and receiving the direct cash transfer.
- Per protocol, participation in the study will be determined based on the inclusion and exclusion criteria. Final eligibility and study participation decisions will be made at the discretion of the Principal Investigator.
Where
- New York, New York
Collaborators
The Bridge Project
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations