Fresh RX: NHS 2020

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. 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.

Official Title
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Fresh RX: Nourishing Healthy Starts Clinical Study

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

Intervention / Treatment
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* Behavioral: FreshRx Nourishing Healthy Starts


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: This is a three-arm experiment where each arm iteratively adds additional program components (see study description for more detail).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enhanced Usual Care<br>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<br>* 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.<br>|
| Experimental: Treatment 1: Nutrition Services<br>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<br>* 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.<br>|
| Experimental: Treatment 2: Integrated Care Services<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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field experiment, food insecurity, pregnancy, maternal health, neonatal health, birth outcomes, poverty, health care utilization, integrative care