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NCT Number: NCT04845230

Fresh RX: NHS 2020

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.

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Key information

About this 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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FreshRx Nourishing Healthy Starts

Behavioral

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.

Primary outcomes

  1. Change in food insecurity

    Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum

    Repeated measures of food insecurity using United States Department of Agriculture (USDA) food insecurity screener

  2. Gestational Age at Birth

    Time frame: Collected at time of birth

    Estimated gestational age (in days) of the child on the delivery date

  3. Birthweight

    Time frame: Collected at time of birth

    Weight (in grams) of infant at birth

Secondary outcomes

  1. Change in food spending

    Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum

    A continuous measure asking about weekly expenditures on groceries and eating and restaurants, and other food options

  2. Change in self reported physical and mental health

    Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum

    Measures captured using an abbreviated 5-item Patient Reported Outcomes Measurement Information System (PROMIS) screener

  3. Number of Prenatal Appointments

    Time frame: Collected quarterly from enrollment through birth

    Number of prenatal health appointments received during pregnancy

  4. Maternal Immunizations Received

    Time frame: Collected quarterly from enrollment through birth

    Pregnancy-related immunizations received (e.g., Tdap, influenza) during pregnancy

  5. Change in Maternal Platelet Count

    Time frame: Collected quarterly from enrollment through birth

    Change in lab results on platelet count from first prenatal visit to final prenatal visit

  6. Change in Maternal White Blood Cell Count

    Time frame: Collected quarterly from enrollment through birth

    Change in lab results on while blood cell count from first prenatal visit to final prenatal visit

  7. Change in Maternal Hematocrit Count

    Time frame: Collected quarterly from enrollment through birth

    Change in lab results on maternal hematocrit count from first prenatal visit to final prenatal visit

  8. Change in Maternal Hemoglobin Count

    Time frame: Collected quarterly from enrollment through birth

    Change in lab results on maternal hemoglobin count from first prenatal visit to final prenatal visit

  9. Change in Maternal Red Blood Cell Count

    Time frame: Collected quarterly from enrollment through birth

    Change in lab results on maternal red blood cell count from first prenatal visit to final prenatal visit

  10. Maternal Anemia Diagnosis

    Time frame: Collected quarterly from enrollment through birth

    Incidence of maternal anemia diagnosis at any point during pregnancy

  11. Fetal Complications Diagnosis

    Time frame: Collected quarterly from enrollment through birth

    Incidence of any common fetal complication diagnosis (e.g., ectopic pregnancy) at any point during pregnancy

  12. Hypertensive Disorder Diagnosis

    Time frame: Collected quarterly from enrollment through birth

    Incidence of any hypertensive disorder diagnosis at any point during pregnancy

  13. Spontaneous Preterm Labor

    Time frame: Collected quarterly from enrollment through birth

    Incidence of spontaneous preterm labor at any point during pregnancy

  14. Preeclampsia Diagnosis

    Time frame: Collected quarterly from enrollment through birth

    Incidence of preeclampsia diagnosis at any point during pregnancy

  15. Difficulty paying bills

    Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum

    A single item measure capturing the incidence of bill payment difficulty in a typical month

  16. Post-partum depression

    Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum

    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

  17. Intrauterine Fetal Demise (IUFD)

    Time frame: Collected quarterly from enrollment through birth

    Incidence of IUFD over course of pregnancy

  18. Spontaneous Abortion

    Time frame: Collected quarterly from enrollment through birth

    Incidence of spontaneous abortion over course of pregnancy

  19. Postpartum Complications

    Time frame: Birth through 60 days post-partum

    Incidence of common postpartum physical health complications (e.g., hypertension, sepsis)

  20. Adverse Post-Partum Mental Health Diagnoses

    Time frame: Birth through 60 days post-partum

    Incidence of common postpartum adverse mental health diagnoses (e.g., anxiety, psychosis)

  21. Maternal Mortality

    Time frame: Birth through 60 days post-partum

    Incidence of maternal mortality

  22. Infant mortality

    Time frame: Birth through 60 days post-partum

    Incidence of infant mortality

  23. Change in food quality

    Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum

    A repeated assessment of the mix of foods consumed through the use of a 24-hour-recall-based food frequency questionnaire

  24. Emergency liquidity

    Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum

    A single item indicator capturing how participants would cover a $400 emergency expense

  25. Public program participation

    Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum

    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

  26. Maternal Hospital Admissions

    Time frame: Collected quarterly from enrollment through one year post-partum

    Measure of hospital admissions derived from health care claims data

  27. Maternal Emergency Room Visits

    Time frame: Collected quarterly from enrollment through one year post-partum

    Measure of emergency room visits derived from health care claims data

  28. Maternal Wellness Visits

    Time frame: Collected quarterly from enrollment through one year post-partum

    Measure of wellness visits derived from health care claims data

  29. Pediatric Visits

    Time frame: Birth through one year post-partum

    Number of pediatric visits in the post-partum period

  30. Infant Adverse Health Diagnoses

    Time frame: Birth through one year post-partum

    Incidence of common infant adverse health diagnoses (e.g., colic, jaundice)

  31. Days in Neonatal Intensive Care Unit (NICU)

    Time frame: Collected from birth through 60 days post-partum

    Length of NICU stay for infant following birth

  32. Admission to Special Care Nursery

    Time frame: Collected from birth through 60 days post-partum

    Incidence of admission to special care nursery

  33. Birth Defects

    Time frame: Collected from birth through 60 days post-partum

    Incidence of common birth defects (e.g., congenital heart defects, cleft palate)

  34. Child Weight

    Time frame: Collected from birth through one year post-partum

    Child weight (grams) post-birth

  35. Child Height

    Time frame: Collected from birth through one year post-partum

    Child height (centimeters) post-birth

  36. Child Hospital Admissions

    Time frame: Collected from birth through one year post-partum

    Number of Hospital Admissions for Child Following Birth

  37. Neonatal death

    Time frame: Collected from birth through one year post-partum

    Incidence of neonatal death

  38. Child Emergency Department Admissions

    Time frame: Collected from birth through one year post-partum

    Number of emergency department admissions following birth

Other outcomes

  1. Change in cooking skills

    Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kourtney Gilbert, MSW

CONTACT

[email protected]

314-935-8142

Stephen Roll, PhD

CONTACT

[email protected]

314-935-3710

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Operation Food Search Inc.

Registry information

Official study title

Fresh RX: Nourishing Healthy Starts Clinical Study

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Apr 14, 2021
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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