Recruiting

Cash Support

Sponsor:

Columbia University

Code:

NCT06923371

Conditions

Maternal and Child Health Outcomes

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

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

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

Study Details

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

Study ID

NCT06923371

Start date

Feb 28, 2025

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: High fee group

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.

other: Low fee group

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.

Interventions

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: 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 measure

  • Number of Preterm Babies [ Time Frame: Immediately after birth ]
  • Number of babies with low birth weight [ Time Frame: Immediately after birth ]
  • Score on Edinburgh Postnatal Depression Scale (EPDS) - Mothers Mental Health [ Time Frame: Baseline, 12 months, 18 months ]
  • Number of Babies Admitted to the NICU [ Time Frame: Immediately after birth ]
  • Gestational Age [ Time Frame: Immediately after birth ]

Central Contacts and Locations

Central contacts

Khadija Jones Clinical Research Manager, MPH

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

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Khadija Jones, MPH

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

Principal Investigator:

Catherine Monk, PhD

More Information

Sponsor

Columbia University

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-05-22.