Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT04845230

Conditions

Premature Birth

Birth Weight

Post Partum Depression

Health Care Utilization

Nutrition Deficiency Due to Insufficient Food

Eligibility Criteria

Sex: Female

Age: 14 - 55

Healthy Volunteers: Accepted

Interventions

FreshRx Nourishing Healthy Starts

Study Details

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.

Conditions

Premature Birth

Birth Weight

Post Partum Depression

Health Care Utilization

Nutrition Deficiency Due to Insufficient Food

Study ID

NCT04845230

Start date

Aug 9, 2021

Status verified date

Nov, 2022

Completion date

Sep 15, 2026

Anticipated

Primary completion date

Sep 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

FreshRx Nourishing Healthy Starts

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.

Primary outcome measure

  • Change in food insecurity [ Time Frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum ]
  • Gestational Age at Birth [ Time Frame: Collected at time of birth ]
  • Birthweight [ Time Frame: Collected at time of birth ]

Central Contacts and Locations

Central contacts

Stephen Roll, PhD

314-935-3710stephen.roll@wustl.edu

Kourtney Gilbert, MSW

314-935-8142kgilbert@wustl.edu

Locations

Operation Food Search Inc.

Recruiting

Saint Louis, Missouri, United States, 63132

Contacts

Nancy Spargo, MSW

314-750-4077nancy.spargo@operationfoodsearch.org

Principal Investigator:

Stephen Roll, PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Nov 29, 2022

Last verified

Nov, 2022

Keywords

  • food insecurity
  • pregnancy
  • maternal health
  • neonatal health
  • birth outcomes
  • poverty
  • health care utilization
  • field experiment
  • integrative care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2022-11-29.