Food and nutrition support for pregnant women facing food insecurity
Fresh RX: Nourishing Healthy Starts Clinical Study
This study is testing a program that gives food and nutrition support to pregnant women in St. Louis who are struggling to get enough to eat, to see if it helps improve their health and the health of their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 14 Years to 55 Years |
| Sex | Female |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT04845230 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Fresh Rx: Nourishing Healthy Starts program, which provides food and nutrition support to food insecure pregnant women in St. Louis. The program includes access to food support programs, direct food delivery, nutrition education, and integrative care services from a social worker. Participants will be screened for food insecurity and randomly assigned to different conditions to assess the program's efficacy and potential cost savings for the healthcare system. The aim is to improve health and birth outcomes for both mothers and their children.
Who should consider this trial
Good fit: Ideal candidates are pregnant women under 24 weeks gestation, aged 14-55, who are food insecure and receiving care through a Missouri Medicaid managed care organization.
Not a fit: Patients who are not pregnant, do not screen positive for food insecurity, or reside outside the specified Missouri zip codes may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve health outcomes for pregnant women and their infants by addressing food insecurity.
How similar studies have performed: Other studies have shown success in addressing food insecurity and improving maternal and neonatal health outcomes, indicating that this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Pregnant * Less than 24 weeks gestation * Screening positive to a USDA two-item food insecurity screener (described below) * Receiving care through a Missouri Medicaid managed care organization * English speaking * Age 14-55 * Missouri resident residing in the following zip codes: 63031, 63033, 63042, 63074, 63114, 63121, 63130, 63132, 63133, 63135, 63136, 63137, 63138, 63140 Exclusion Criteria: * Male * Non-pregnant * Pregnant, but more than 24 weeks gestation * Does not screen positive to a USDA two-item food insecurity screener (described below) * Does not receive care through the Home State Health managed care organization * Non-English speaking * Aged less than 14 or more than 55 * Does not reside in the following zip codes: 63031, 63033, 63042, 63074, 63114, 63121, 63130, 63132, 63133, 63135, 63136, 63137, 63138, 63140
Where this trial is running
St Louis, Missouri
- Operation Food Search Inc. — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Stephen Roll, PhD — Washington University School of Medicine
- Study coordinator: Stephen Roll, PhD
- Email: stephen.roll@wustl.edu
- Phone: 314-935-3710
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.