| NCT ID | NCT04845230 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Premature Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2021-08-09 |
| Primary Completion | 2025-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 750 participants in total. It began in 2021-08-09 with a primary completion date of 2025-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is an evaluation of the Fresh Rx: Nourishing Healthy Starts program administered by Operation Food Search, a St. Louis-based nonprofit organization. The program provides food and nutrition supports to food insecure pregnant women in conjunction with integrative care services in order to improve health and birth outcomes for both the mother and the child. The purpose of this study is to test the efficacy of this approach through a field experiment, and to assess the extent to which these services can provide cost savings to the healthcare system.
Eligibility 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
Contact & Investigator
Stephen Roll, PhD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT04845230 clinical trial?
This trial is open to female participants only, aged 14 Years or older, up to 55 Years, studying Premature Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04845230 currently recruiting?
Yes, NCT04845230 is actively recruiting participants. Contact the research team at stephen.roll@wustl.edu for enrollment information.
Where is the NCT04845230 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT04845230 clinical trial?
NCT04845230 is sponsored by Washington University School of Medicine. The principal investigator is Stephen Roll, PhD at Washington University School of Medicine. The trial plans to enroll 750 participants.