Clinical trial NCT04845230: Fresh RX: NHS 2020
Official title: Fresh RX: Nourishing Healthy Starts Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Birth
Birth Weight
Post Partum Depression
Health Care Utilization
Nutrition Deficiency Due to Insufficient Food
Housing Problems
Fetal Complications
Food Deprivation
Keywords: food insecurity
pregnancy
maternal health
neonatal health
birth outcomes
poverty
health care utilization
field experiment
integrative care
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Operation Food Search Inc.
First posted: 2021-04-14
Enrollment: 750
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is a three-arm experiment where each arm iteratively adds additional program components (see study description for more detail).
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in food insecurity
timeFrame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
measure: Gestational Age at Birth
timeFrame: Collected at time of birth
measure: Birthweight
timeFrame: Collected at time of birth
Secondary outcomes:
measure: Change in food spending
timeFrame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
measure: Change in self reported physical and mental health
timeFrame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
measure: Number of Prenatal Appointments
timeFrame: Collected quarterly from enrollment through birth
measure: Maternal Immunizations Received
timeFrame: Collected quarterly from enrollment through birth
measure: Change in Maternal Platelet Count
timeFrame: Collected quarterly from enrollment through birth
measure: Change in Maternal White Blood Cell Count
timeFrame: Collected quarterly from enrollment through birth
measure: Change in Maternal Hematocrit Count
timeFrame: Collected quarterly from enrollment through birth
measure: Change in Maternal Hemoglobin Count
timeFrame: Collected quarterly from enrollment through birth
measure: Change in Maternal Red Blood Cell Count
timeFrame: Collected quarterly from enrollment through birth
measure: Maternal Anemia Diagnosis
timeFrame: Collected quarterly from enrollment through birth
measure: Fetal Complications Diagnosis
timeFrame: Collected quarterly from enrollment through birth
measure: Hypertensive Disorder Diagnosis
timeFrame: Collected quarterly from enrollment through birth
measure: Spontaneous Preterm Labor
timeFrame: Collected quarterly from enrollment through birth
measure: Preeclampsia Diagnosis
timeFrame: Collected quarterly from enrollment through birth
measure: Difficulty paying bills
timeFrame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
measure: Post-partum depression
timeFrame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
measure: Intrauterine Fetal Demise (IUFD)
timeFrame: Collected quarterly from enrollment through birth
measure: Spontaneous Abortion
timeFrame: Collected quarterly from enrollment through birth
measure: Postpartum Complications
timeFrame: Birth through 60 days post-partum
measure: Adverse Post-Partum Mental Health Diagnoses
timeFrame: Birth through 60 days post-partum
measure: Maternal Mortality
timeFrame: Birth through 60 days post-partum
measure: Infant mortality
timeFrame: Birth through 60 days post-partum
measure: Change in food quality
timeFrame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
measure: Emergency liquidity
timeFrame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
measure: Public program participation
timeFrame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
measure: Maternal Hospital Admissions
timeFrame: Collected quarterly from enrollment through one year post-partum
measure: Maternal Emergency Room Visits
timeFrame: Collected quarterly from enrollment through one year post-partum
measure: Maternal Wellness Visits
timeFrame: Collected quarterly from enrollment through one year post-partum
measure: Pediatric Visits
timeFrame: Birth through one year post-partum
measure: Infant Adverse Health Diagnoses
timeFrame: Birth through one year post-partum
measure: Days in Neonatal Intensive Care Unit (NICU)
timeFrame: Collected from birth through 60 days post-partum
measure: Admission to Special Care Nursery
timeFrame: Collected from birth through 60 days post-partum
measure: Birth Defects
timeFrame: Collected from birth through 60 days post-partum
measure: Child Weight
timeFrame: Collected from birth through one year post-partum
measure: Child Height
timeFrame: Collected from birth through one year post-partum
measure: Child Hospital Admissions
timeFrame: Collected from birth through one year post-partum
measure: Neonatal death
timeFrame: Collected from birth through one year post-partum
measure: Child Emergency Department Admissions
timeFrame: Collected from birth through one year post-partum
Other outcomes:
measure: Change in cooking skills
timeFrame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Locations:
city: Saint Louis
country: United States
facility: Operation Food Search Inc.
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Stephen Roll, PhD
role: PRINCIPAL_INVESTIGATOR
References: