| 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 |
Trial Parameters
Eligibility Fast-Check
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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