Fresh RX: NHS 2020

Premature Birth Clinical Trial

Official title:

Fresh RX: Nourishing Healthy Starts Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04845230
• Other study ID #: 202011018
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2021
• Est. completion date: September 15, 2026

Study information

• Verified date: November 2022
• Source: Washington University School of Medicine
• Contact: Stephen Roll, PhD
• Phone: 314-935-3710
• Email: stephen.roll[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: September 15, 2026
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Operation Food Search Inc.	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Operation Food Search Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	Gestational Age at Birth	Estimated gestational age (in days) of the child on the delivery date	Collected at time of birth
Primary	Birthweight	Weight (in grams) of infant at birth	Collected at time of birth
Secondary	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
Secondary	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
Secondary	Number of Prenatal Appointments	Number of prenatal health appointments received during pregnancy	Collected quarterly from enrollment through birth
Secondary	Maternal Immunizations Received	Pregnancy-related immunizations received (e.g., Tdap, influenza) during pregnancy	Collected quarterly from enrollment through birth
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Maternal Anemia Diagnosis	Incidence of maternal anemia diagnosis at any point during pregnancy	Collected quarterly from enrollment through birth
Secondary	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
Secondary	Hypertensive Disorder Diagnosis	Incidence of any hypertensive disorder diagnosis at any point during pregnancy	Collected quarterly from enrollment through birth
Secondary	Spontaneous Preterm Labor	Incidence of spontaneous preterm labor at any point during pregnancy	Collected quarterly from enrollment through birth
Secondary	Preeclampsia Diagnosis	Incidence of preeclampsia diagnosis at any point during pregnancy	Collected quarterly from enrollment through birth
Secondary	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
Secondary	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
Secondary	Intrauterine Fetal Demise (IUFD)	Incidence of IUFD over course of pregnancy	Collected quarterly from enrollment through birth
Secondary	Spontaneous Abortion	Incidence of spontaneous abortion over course of pregnancy	Collected quarterly from enrollment through birth
Secondary	Postpartum Complications	Incidence of common postpartum physical health complications (e.g., hypertension, sepsis)	Birth through 60 days post-partum
Secondary	Adverse Post-Partum Mental Health Diagnoses	Incidence of common postpartum adverse mental health diagnoses (e.g., anxiety, psychosis)	Birth through 60 days post-partum
Secondary	Maternal Mortality	Incidence of maternal mortality	Birth through 60 days post-partum
Secondary	Infant mortality	Incidence of infant mortality	Birth through 60 days post-partum
Secondary	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
Secondary	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
Secondary	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
Secondary	Maternal Hospital Admissions	Measure of hospital admissions derived from health care claims data	Collected quarterly from enrollment through one year post-partum
Secondary	Maternal Emergency Room Visits	Measure of emergency room visits derived from health care claims data	Collected quarterly from enrollment through one year post-partum
Secondary	Maternal Wellness Visits	Measure of wellness visits derived from health care claims data	Collected quarterly from enrollment through one year post-partum
Secondary	Pediatric Visits	Number of pediatric visits in the post-partum period	Birth through one year post-partum
Secondary	Infant Adverse Health Diagnoses	Incidence of common infant adverse health diagnoses (e.g., colic, jaundice)	Birth through one year post-partum
Secondary	Days in Neonatal Intensive Care Unit (NICU)	Length of NICU stay for infant following birth	Collected from birth through 60 days post-partum
Secondary	Admission to Special Care Nursery	Incidence of admission to special care nursery	Collected from birth through 60 days post-partum
Secondary	Birth Defects	Incidence of common birth defects (e.g., congenital heart defects, cleft palate)	Collected from birth through 60 days post-partum
Secondary	Child Weight	Child weight (grams) post-birth	Collected from birth through one year post-partum
Secondary	Child Height	Child height (centimeters) post-birth	Collected from birth through one year post-partum
Secondary	Child Hospital Admissions	Number of Hospital Admissions for Child Following Birth	Collected from birth through one year post-partum
Secondary	Neonatal death	Incidence of neonatal death	Collected from birth through one year post-partum
Secondary	Child Emergency Department Admissions	Number of emergency department admissions following birth	Collected from birth through one year post-partum