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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
750
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.
Operation Food Search Inc.
St Louis, Missouri, United States
RECRUITINGChange in food insecurity
Repeated measures of food insecurity using United States Department of Agriculture (USDA) food insecurity screener
Time frame: 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
Time frame: Collected at time of birth
Birthweight
Weight (in grams) of infant at birth
Time frame: Collected at time of birth
Change in food spending
A continuous measure asking about weekly expenditures on groceries and eating and restaurants, and other food options
Time frame: 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
Time frame: 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
Time frame: Collected quarterly from enrollment through birth
Maternal Immunizations Received
Pregnancy-related immunizations received (e.g., Tdap, influenza) during pregnancy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Collected quarterly from enrollment through birth
Maternal Anemia Diagnosis
Incidence of maternal anemia diagnosis at any point during pregnancy
Time frame: 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
Time frame: Collected quarterly from enrollment through birth
Hypertensive Disorder Diagnosis
Incidence of any hypertensive disorder diagnosis at any point during pregnancy
Time frame: Collected quarterly from enrollment through birth
Spontaneous Preterm Labor
Incidence of spontaneous preterm labor at any point during pregnancy
Time frame: Collected quarterly from enrollment through birth
Preeclampsia Diagnosis
Incidence of preeclampsia diagnosis at any point during pregnancy
Time frame: Collected quarterly from enrollment through birth
Difficulty paying bills
A single item measure capturing the incidence of bill payment difficulty in a typical month
Time frame: 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
Time frame: 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
Time frame: Collected quarterly from enrollment through birth
Spontaneous Abortion
Incidence of spontaneous abortion over course of pregnancy
Time frame: Collected quarterly from enrollment through birth
Postpartum Complications
Incidence of common postpartum physical health complications (e.g., hypertension, sepsis)
Time frame: Birth through 60 days post-partum
Adverse Post-Partum Mental Health Diagnoses
Incidence of common postpartum adverse mental health diagnoses (e.g., anxiety, psychosis)
Time frame: Birth through 60 days post-partum
Maternal Mortality
Incidence of maternal mortality
Time frame: Birth through 60 days post-partum
Infant mortality
Incidence of infant mortality
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Collected quarterly from enrollment through one year post-partum
Maternal Emergency Room Visits
Measure of emergency room visits derived from health care claims data
Time frame: Collected quarterly from enrollment through one year post-partum
Maternal Wellness Visits
Measure of wellness visits derived from health care claims data
Time frame: Collected quarterly from enrollment through one year post-partum
Pediatric Visits
Number of pediatric visits in the post-partum period
Time frame: Birth through one year post-partum
Infant Adverse Health Diagnoses
Incidence of common infant adverse health diagnoses (e.g., colic, jaundice)
Time frame: Birth through one year post-partum
Days in Neonatal Intensive Care Unit (NICU)
Length of NICU stay for infant following birth
Time frame: Collected from birth through 60 days post-partum
Admission to Special Care Nursery
Incidence of admission to special care nursery
Time frame: Collected from birth through 60 days post-partum
Birth Defects
Incidence of common birth defects (e.g., congenital heart defects, cleft palate)
Time frame: Collected from birth through 60 days post-partum
Child Weight
Child weight (grams) post-birth
Time frame: Collected from birth through one year post-partum
Child Height
Child height (centimeters) post-birth
Time frame: Collected from birth through one year post-partum
Child Hospital Admissions
Number of Hospital Admissions for Child Following Birth
Time frame: Collected from birth through one year post-partum
Neonatal death
Incidence of neonatal death
Time frame: Collected from birth through one year post-partum
Child Emergency Department Admissions
Number of emergency department admissions following birth
Time frame: Collected from birth through one year post-partum
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