Fresh RX: NHS 2020

Fresh RX: Nourishing Healthy Starts Clinical Study

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.

Study Overview

• Status: Recruiting
• Conditions: Premature Birth; Birth Weight; Post Partum Depression; Fetal Complications; Health Care Utilization; Food Deprivation; Housing Problems; Nutrition Deficiency Due to Insufficient Food
• Intervention / Treatment: Behavioral: FreshRx Nourishing Healthy Starts

Detailed Description

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 goal of the program is to provide food and nutrition supports to food insecure pregnant women in order to improve health and birth outcomes for both the mother and the child. Specifically, this program provides:

• Facilitated access to food support programs like the Supplemental Nutrition Assistance Program (SNAP); Women, Infants, and Children (WIC); and food pantries
• Direct food delivery to pregnant women, nutrition education, and access to a registered dietitian
• Access to a social worker who will provide integrative care services

Participants in this program will be recruited through a Medicaid Managed Care Organization (MCO). During their initial intake meeting with an MCO case manager, potential participants will be screened for food insecurity through the use of a two-item food insecurity screener. If a potential participant screens positive for food insecurity, she will be referred to Operation Food Search to begin the Nourishing Healthy Starts recruitment process. Consenting participants will be randomly assigned to one of three conditions (described in detail below), each of which provides the standard of care women would receive in the absence of the program plus additional program features.

Control Group. 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.

Treatment 1: Food Supplementation and Education Group. This treatment group will receive all the services offered to the control group, as well as the following services:

1. Weekly food deliveries of fresh food meal kits with step-by-step recipes from the time of program enrollment through 60 days post-partum;
2. Access to necessary cooking tools for their kitchen (e.g., spatulas, cutting boards , etc.), should they need them.
3. Access to online cooking resources to help guide them on culinary skills and recipe preparation.
4. Nutrition education and counseling provided by a registered dietitian.

Treatment 2: Food Supplementation, Education, and Integrative Case Management. This treatment group will receive all the services offered to Treatment Group 1, as well as the services of a licensed 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.

This evaluation will combine longitudinal survey data from participants with health claims data provided by the MCOs. Study participants will consent to have their data collected and linked for research purposes. The research team will not have access to any personally identifiable information on program participants, and the team will analyze a deidentified dataset.

Each intervention approach will examine a different method of providing women with access to affordable, nutritious food throughout their pregnancy and through the early post-partum period. After it is determined how best to support food insecure women and their families, the evidence from this study may be used to make a case for treating healthy food supports as part of a new standard of care for food insecure pregnant women. The results will provide information to public health agencies, public insurance systems, Medicaid MCOs, and other insurance companies in order to help them understand the potential benefits of these food supports.

• Study Type: Interventional
• Enrollment (Anticipated): 750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen Roll, PhD; Phone Number: 314-935-3710; Email: stephen.roll@wustl.edu
• Study Contact Backup: Name: Kourtney Gilbert, MSW; Phone Number: 314-935-8142; Email: kgilbert@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63132
      • Recruiting
      • Operation Food Search Inc.
      • Contact: Nancy Spargo, MSW; Phone Number: 314-750-4077; Email: nancy.spargo@operationfoodsearch.org
      • Principal Investigator: Stephen Roll, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 55 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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.	Behavioral: 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.
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in food insecurity	Repeated measures of food insecurity using United States Department of Agriculture (USDA) food insecurity screener	Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Gestational Age at Birth	Estimated gestational age (in days) of the child on the delivery date	Collected at time of birth
Birthweight	Weight (in grams) of infant at birth	Collected at time of birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in food spending	A continuous measure asking about weekly expenditures on groceries and eating and restaurants, and other food options	Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Change in self reported physical and mental health	Measures captured using an abbreviated 5-item Patient Reported Outcomes Measurement Information System (PROMIS) screener	Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Number of Prenatal Appointments	Number of prenatal health appointments received during pregnancy	Collected quarterly from enrollment through birth
Maternal Immunizations Received	Pregnancy-related immunizations received (e.g., Tdap, influenza) during pregnancy	Collected quarterly from enrollment through birth
Change in Maternal Platelet Count	Change in lab results on platelet count from first prenatal visit to final prenatal visit	Collected quarterly from enrollment through birth
Change in Maternal White Blood Cell Count	Change in lab results on while blood cell count from first prenatal visit to final prenatal visit	Collected quarterly from enrollment through birth
Change in Maternal Hematocrit Count	Change in lab results on maternal hematocrit count from first prenatal visit to final prenatal visit	Collected quarterly from enrollment through birth
Change in Maternal Hemoglobin Count	Change in lab results on maternal hemoglobin count from first prenatal visit to final prenatal visit	Collected quarterly from enrollment through birth
Change in Maternal Red Blood Cell Count	Change in lab results on maternal red blood cell count from first prenatal visit to final prenatal visit	Collected quarterly from enrollment through birth
Maternal Anemia Diagnosis	Incidence of maternal anemia diagnosis at any point during pregnancy	Collected quarterly from enrollment through birth
Fetal Complications Diagnosis	Incidence of any common fetal complication diagnosis (e.g., ectopic pregnancy) at any point during pregnancy	Collected quarterly from enrollment through birth
Hypertensive Disorder Diagnosis	Incidence of any hypertensive disorder diagnosis at any point during pregnancy	Collected quarterly from enrollment through birth
Spontaneous Preterm Labor	Incidence of spontaneous preterm labor at any point during pregnancy	Collected quarterly from enrollment through birth
Preeclampsia Diagnosis	Incidence of preeclampsia diagnosis at any point during pregnancy	Collected quarterly from enrollment through birth
Difficulty paying bills	A single item measure capturing the incidence of bill payment difficulty in a typical month	Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Post-partum depression	Collected through the Edinburgh Post-partum Depression Scale. This scale is score 0 to 30, with higher values indicator higher risk for post-partum depression	Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Intrauterine Fetal Demise (IUFD)	Incidence of IUFD over course of pregnancy	Collected quarterly from enrollment through birth
Spontaneous Abortion	Incidence of spontaneous abortion over course of pregnancy	Collected quarterly from enrollment through birth
Postpartum Complications	Incidence of common postpartum physical health complications (e.g., hypertension, sepsis)	Birth through 60 days post-partum
Adverse Post-Partum Mental Health Diagnoses	Incidence of common postpartum adverse mental health diagnoses (e.g., anxiety, psychosis)	Birth through 60 days post-partum
Maternal Mortality	Incidence of maternal mortality	Birth through 60 days post-partum
Infant mortality	Incidence of infant mortality	Birth through 60 days post-partum
Change in food quality	A repeated assessment of the mix of foods consumed through the use of a 24-hour-recall-based food frequency questionnaire	Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Emergency liquidity	A single item indicator capturing how participants would cover a $400 emergency expense	Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Public program participation	A matrix question capturing the incidence of participation in common public welfare programs: Supplemental Nutrition Assistance (SNAP); Temporary Assistance for Needy Families (TANF); Public Housing/Housing Choice Vouchers; Women, Infants, and Children (WIC); Utility assistance; Child care assistance	Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Maternal Hospital Admissions	Measure of hospital admissions derived from health care claims data	Collected quarterly from enrollment through one year post-partum
Maternal Emergency Room Visits	Measure of emergency room visits derived from health care claims data	Collected quarterly from enrollment through one year post-partum
Maternal Wellness Visits	Measure of wellness visits derived from health care claims data	Collected quarterly from enrollment through one year post-partum
Pediatric Visits	Number of pediatric visits in the post-partum period	Birth through one year post-partum
Infant Adverse Health Diagnoses	Incidence of common infant adverse health diagnoses (e.g., colic, jaundice)	Birth through one year post-partum
Days in Neonatal Intensive Care Unit (NICU)	Length of NICU stay for infant following birth	Collected from birth through 60 days post-partum
Admission to Special Care Nursery	Incidence of admission to special care nursery	Collected from birth through 60 days post-partum
Birth Defects	Incidence of common birth defects (e.g., congenital heart defects, cleft palate)	Collected from birth through 60 days post-partum
Child Weight	Child weight (grams) post-birth	Collected from birth through one year post-partum
Child Height	Child height (centimeters) post-birth	Collected from birth through one year post-partum
Child Hospital Admissions	Number of Hospital Admissions for Child Following Birth	Collected from birth through one year post-partum
Neonatal death	Incidence of neonatal death	Collected from birth through one year post-partum
Child Emergency Department Admissions	Number of emergency department admissions following birth	Collected from birth through one year post-partum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cooking skills	Incidence of using basic and advanced kitchen tasks. Participants will be asked how often they perform an array of given tasks (Never, Rarely, Monthly, Weekly, Daily) such as boiling water, following a recipe, using a chef's knife, and so on, through a matrix question listing these tasks.	Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Operation Food Search Inc.
• Investigators: Principal Investigator: Stephen Roll, PhD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 9, 2021
• Primary Completion (ANTICIPATED): September 15, 2025
• Study Completion (ANTICIPATED): September 15, 2026

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (ACTUAL): April 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 27, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: pregnancy; maternal health; birth outcomes; health care utilization; food insecurity; poverty; neonatal health; field experiment; integrative care
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Body Weight; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Obstetric Labor, Premature; Depressive Disorder; Depression, Postpartum; Premature Birth; Birth Weight
• Other Study ID Numbers: 202011018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No