Direct Cash Support for Maternal and Infant Health

(MBHW Trial)

Overseen By Khadija Jones Clinical Research Manager, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Terminal cancer, Severe addiction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

1250 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on financial support rather than medical treatments, so you may not need to change your medications.

What data supports the effectiveness of the treatment Direct Cash Support for Maternal and Infant Health?

Research suggests that financial incentives, like direct cash support, can increase the use and quality of maternal health services by encouraging more women to seek care and improving service delivery. However, while these incentives can enhance service utilization, there is limited direct evidence linking them to improved health outcomes for mothers and infants. ^{1 2 3 4 5}

How does the Direct Cash Support for Maternal and Infant Health treatment differ from other treatments for maternal and infant health?

This treatment is unique because it involves providing direct cash support to mothers, which is a form of demand-side financing aimed at improving maternal and infant health by offsetting financial costs and incentivizing healthy behaviors. Unlike traditional medical treatments, this approach focuses on financial incentives to increase the use and quality of maternity care services. ^{3 6 7 8 9}

What is the purpose of 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.

Research Team

Catherine Monk, PhD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for pregnant women in the U.S., particularly those facing financial challenges. It's designed to see if direct cash support can improve health outcomes for them and their babies. Women must be willing to complete surveys and allow access to medical records.

Inclusion Criteria

* Living in any of the study sites: Appalachian regions (West Virginia, Ohio, Kentucky)

* Being in the first or second trimester

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline Survey

Participants complete a baseline survey upon enrollment

1 week

1 visit (in-person or virtual)

Intervention

Participants receive either a high or low cash allowance to evaluate the impact on maternal and infant health outcomes

18 months

Ongoing monitoring through surveys and medical record reviews

Follow-up

Participants complete follow-up surveys at 12 and 18 months after enrollment to assess health outcomes

6 months

2 visits (virtual)

Treatment Details

Interventions

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

Trial Overview The study tests whether providing extra money during pregnancy and early motherhood (in high or low amounts) leads to better maternal and infant health. Participants will be randomly assigned to receive different levels of financial support.

Participant Groups

Group I: Low fee group Experimental Treatment 1 Intervention

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.

Group II: High fee group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

The Bridge Project

Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of results-based financing on facility-based maternal mortality at birth: an interrupted time-series analysis with independent controls in Malawi. [2023]

2. Bangladesh pubmed.ncbi.nlm.nih.gov

Investigating financial incentives for maternal health: an introduction. [2014]

3. Bangladesh pubmed.ncbi.nlm.nih.gov

Financial incentives and maternal health: where do we go from here? [2022]

4. England pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of using performance-based financing to deliver the basic package of health services in Afghanistan. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Incentives for pregnant mothers during antenatal care for better maternal and neonatal health outcomes in low and middle income countries: A systematic review protocol. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The effects of cash transfers and vouchers on the use and quality of maternity care services: A systematic review. [2023]

7. Australia pubmed.ncbi.nlm.nih.gov

Maternal and infant health prepayment schemes in Shandong, China: a survey of demand and supply. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Demand-side financing for maternal and newborn health: what do we know about factors that affect implementation of cash transfers and voucher programmes? [2023]

9. England pubmed.ncbi.nlm.nih.gov

Effects of demand-side financing on utilisation, experiences and outcomes of maternity care in low- and middle-income countries: a systematic review. [2022]