Fresh RX: NHS 2020

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT04845230
Status
Recruiting
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Conditions

  • Birth Weight
  • Fetal Complications
  • Food Deprivation
  • Health Care Utilization
  • Housing Problems
  • Nutrition Deficiency Due to Insufficient Food
  • Post Partum Depression
  • Premature Birth

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • FreshRx Nourishing Healthy Starts — BEHAVIORAL
    This is a field experiment study that incorporates referrals to public programs, food supplementation and nutrition education, or integrative care services provided by a Licensed Masters Social Worker.

Study Details

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.

Key Dates

Start date
Aug 9, 2021
Status verified
Nov 2022
Primary completion
Sep 15, 2025
Completion
Sep 15, 2026

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Enhanced Usual Care
    The control group in this study will still receive some services above and beyond the usual standard of care offered to pregnant women on Medicaid. In addition to the case management services offered through their managed care provider, Operation Food Search will offer this group access to the "hunger hotline," a service provided by Operation Food Search to help them find food assistance around St. Louis; assistance in enrolling in public nutrition assistance programs like SNAP and WIC; and guidance on food pantry access in St. Louis.
  • Experimental: Treatment 1: Nutrition Services
    This treatment group will receive all the services offered to the control group, as well as the following services: Weekly food deliveries of fresh food meal kits with step-by-step recipes from the time of program enrollment through 60 days post-partum. Access to necessary cooking tools for their kitchen (e.g., spatulas, cutting boards , etc.), should they need them. Access to online cooking resources to help guide them on culinary skills and recipe preparation. Nutrition education and counseling provided by a registered dietitian.
  • Experimental: Treatment 2: Integrated Care Services
    This treatment group will receive all the services offered to Treatment Group 1, as well as the services of a Licensed Masters Social Worker who will provide trauma-informed integrative care services to participants. These services will focus on an array of potential needs that may emerge in participants' lives, such as assistance in finding stable housing, assistance navigating social services, connections with other community organizations, and other needs.

Primary Outcome Measure

Change in food insecurity [ Time Frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Operation Food Search Inc.St LouisMissouri63132
Nancy Spargo, MSW
[email protected]
314-750-4077
Stephen Roll, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Operation Food Search Inc.· St Louis, MO

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