Moms and Babies Health and Well-being

Not Applicable

Recruiting

• Conditions: Maternal and Child Health Outcomes

• Registration Number: NCT06923371
• Lead Sponsor: Columbia University

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.

Detailed Description

In 2022, the United States witnessed a concerning statistic: approximately 1 in 5 children lived in poverty, marking the highest child poverty rate among high-income countries. This figure becomes even more alarming when examining specific demographic groups. Research from the Center on Budget and Policy Priorities reveals that 1 in 2 Black and Latino households with children reported financial hardships, compared to 1 in 4 white households with children. Furthermore, Black children were nearly three times as likely to live in poverty as White children in 2017, even after accounting for government assistance. According to the Census Bureau, the expiration of pandemic-related social support programs at the end of COVID-19 coincided with a dramatic increase in the national child poverty rate, which surged from 5.2% in 2021 to 12.4% in 2022.

Simultaneously, maternal mortality, particularly among impoverished pregnant women, has become a pressing public health issue. Over the last three decades, the maternal mortality rate in the U.S. has doubled from 7 per 100,000 live births in 1986 to 17 per 100,000 in 2016, with disproportionately higher rates among Black and Brown women. During the COVID-19 pandemic, the National Center for Health Statistics reported an 18.4% increase in deaths during pregnancy or the post-natal period in 2019 and 2020. According to the Centers for Disease Control and Prevention (CDC), 4 in 5 of these deaths were preventable, with the leading causes being mental health conditions (23%), hemorrhage (14%), cardiac and coronary conditions (13%), and infections (9%). Studies have emphasized the critical role of social determinants of health, such as access to care, food security, housing, and safety, in influencing maternal mortality outcomes. Addressing these factors is crucial to improving the health and well-being of both mothers and their children.

A decade ago, promising data from the Manitoba study in Canada demonstrated the positive influence of cash allowances on improving maternal health during pregnancy and perinatal conditions. However, questions remain regarding whether these findings can be replicated in a post-pandemic U.S. context. In particular, there is limited understanding of the optimal timing and duration of prenatal stipend programs to maximize their impact on birth outcomes and child health during the first two years of life. While existing research sheds light on the benefits of financial support during pregnancy-such as improvements in birth outcomes, child immunization, and health behaviors in the first year-less is known about the long-term effects of cash allowances extending beyond delivery into the child's early years. Investigating this specific timeframe could provide valuable insights to inform policies aimed at reducing poverty and improving health outcomes for vulnerable populations.

This clinical trial seeks to explore the effects of providing direct financial support (unconditional cash transfers) to pregnant women on their health and the health of their babies. Specifically, the study will examine the impact of cash allowances on maternal physical and mental health, healthcare access, nutrition, and the child's growth and overall health during the first two years of life.

Participants will be randomly assigned to either a high cash or low cash group. Each participant will: (1) Complete a baseline survey upon enrollment (2) Complete a follow-up survey 12 months after enrollment. (3) Complete a final survey 18 months after enrollment.

Additionally, the study will review participants' medical records and may include qualitative interviews with some participants to better understand their experiences with cash support and health outcomes.

This research is conducted in collaboration with The Bridge Project (TBP), a New York-based non-governmental organization (NGO) founded in 2021, which offers unconditional cash transfers to mothers of infants born into poverty. This study will assess how these transfers impact maternal and child health outcomes. The findings of this study will provide critical data on the potential benefits of unconditional cash transfers for maternal and child health. These findings could inform public health policy and programs designed to alleviate poverty and promote health equity for vulnerable populations.

The researchers aim to:

* Evaluate the impact of a cash allowance program, initiated in the first trimester or second of pregnancy, on birth outcomes and toddler health.

* Assess the influence of cash allowances on maternal physical and mental health across the pre- and postnatal periods.

* Investigate the combined effects of cash allowances and health insurance on healthcare access and service utilization.

* Explore the role of cash allowances in improving the nutritional quality of diets among pregnant and breastfeeding mothers.

This study will conduct a prospective mixed-methods investigation from October 2024 to December 2027, incorporating both quantitative and qualitative components through cross-sectional surveys, medical record reviews, and focus groups and/or in-depth qualitative interviews.

Study Timeline

• Study Start: 2025-02-28
• Status Verified: 2025-04
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Primary Completion: 2027-08
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1250

Inclusion Criteria

• Living in any of the study sites: Appalachian regions (West Virginia, Ohio, Kentucky)
• 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 severe addiction disorders.
• 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Preterm Babies	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	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	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	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	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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States