Moms and Babies Health and Well-being
ConditionMaternal and Child Health Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Direct Cash Support for Maternal and Infant Health (High fee)
BehavioralThe 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)
BehavioralThe 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.
Treatment groups
1,250 Participants
are divided into 2 treatment groupsGroup A: High fee groupOther 1 intervention
Group B: Low fee groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediately after birth2
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.
Time frame
Immediately after birth3
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.
Time frame
Baseline, 12 months, 18 months4
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.
Time frame
Immediately after birthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
The Bridge Project
Collaborator
Source ClinicalTrials.gov