Moms and Babies Health and Well-being

NCT06923371 | Recruiting

• 2 other identifiers: AAAV2019BP CU24-1156
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Maternal and Child Health Outcomes

Keywords

unconditional cash transfers; maternal health; child health; pregnancy outcomes; postpartum health; healthcare access; nutrition; social determinants of health; cash allowance program; perinatal health

Outcome Measures

Primary Outcomes (5)

• Number of Preterm Babies

  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.

  Immediately after birth

• Number of babies with low birth weight

  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.

  Immediately after birth

• Score on Edinburgh Postnatal Depression Scale (EPDS) - Mothers Mental Health

  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.

  Baseline, 12 months, 18 months

• Number of Babies Admitted to the NICU

  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.

  Immediately after birth

• Gestational Age

  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.

  Immediately after birth

Study Arms (2)

High fee group

OTHER

Participants in the high-fee group will receive a larger monetary allowance to evaluate the impact of increased financial support on the health outcomes of pregnant women and their babies. This intervention will assess whether greater financial resources during pregnancy and early infancy improve baby growth, maternal well-being, healthcare access, and healthier decision-making.

Behavioral: Direct Cash Support for Maternal and Infant Health (High fee)

Low fee group

OTHER

Participants in the low-fee group will receive a smaller monetary allowance to explore the impact of moderate financial support on maternal and infant health outcomes. The intervention will assess whether financial assistance during pregnancy and early infancy improves baby growth, maternal well-being, healthcare access, and healthier food choices. By comparing this group to the high-fee group, the researchers aim to understand how different levels of financial support affect health outcomes in economically challenged populations.

Behavioral: Behavioral: Direct Cash Support for Maternal and Infant Health (Low fee)

Interventions

Direct Cash Support for Maternal and Infant Health (High fee) BEHAVIORAL

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.

High fee group

Behavioral: Direct Cash Support for Maternal and Infant Health (Low fee) BEHAVIORAL

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.

Low fee group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• The Bridge Project: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Interventions

Infant Health

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Officials

• Catherine Monk, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khadija Jones Clinical Research Manager, MPH

CONTACT

917-817-1490; kj2660@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The Columbia research team will be blinded to intervention status excluding the PI and the Data Manager.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Women's Mental Health

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

US (1)