Fresh RX: NHS 2020

• ClinicalTrials.gov Identifier: NCT04845230
• Recruitment Status: Recruiting
• First Posted: April 14, 2021
• Last Update Posted: August 16, 2021
• Sponsor: Washington University School of Medicine
• Collaborator: Operation Food Search Inc.
• Information provided by (Responsible Party): Washington University School of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Premature Birth; Birth Weight; Post Partum Depression; Health Care Utilization; Nutrition Deficiency Due to Insufficient Food; Housing Problems; Fetal Complications; Food Deprivation	Behavioral: FreshRx Nourishing Healthy Starts	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 750 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: This is a three-arm experiment where each arm iteratively adds additional program components (see study description for more detail).
• Masking: Single (Outcomes Assessor)
• Masking Description: Blinding of participants or Operation Food Search staff is infeasible in this study. Operation Food Search will need to know participants' treatment assignment in order to provide the appropriate services, and the participants will also be aware of the services they receive from Operation Food Search. However, the administrative health care claims data used to assess outcomes in this study will not be subject to any bias, as the entities responsible for entering those claims will be blind to the treatment assignment of participants.
• Primary Purpose: Prevention
• Official Title: Fresh RX: Nourishing Healthy Starts Clinical Study
• Actual Study Start Date: August 9, 2021
• Estimated Primary Completion Date: September 15, 2024
• Estimated Study Completion Date: September 15, 2025

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Enhanced Usual Care; 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; 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.
Experimental: Treatment 1: Nutrition Services; 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; 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.
Experimental: Treatment 2: Integrated Care Services; 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; 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 55 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: This study is an evaluation of a program that provides food and nutrition supports to food insecure pregnant women.
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Stephen Roll, PhD; 314-935-3710; stephen.roll@wustl.edu

Contact: Kourtney Gilbert, MSW; 314-935-8142; kgilbert@wustl.edu

Locations

United States, Missouri

Operation Food Search Inc.; Recruiting

Saint Louis, Missouri, United States, 63132

Contact: Katie Simpson, MSW 314-938-9109 katie.simpson@operationfoodsearch.org

Principal Investigator: Stephen Roll, PhD

Sponsors and Collaborators

Washington University School of Medicine

Operation Food Search Inc.

Investigators

• Principal Investigator: Stephen Roll, PhD; Washington University School of Medicine

More Information

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT04845230
• Other Study ID Numbers: 202011018
• First Posted: April 14, 2021
• Last Update Posted: August 16, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:

food insecurity; pregnancy; maternal health; neonatal health; birth outcomes; poverty; health care utilization; field experiment; integrative care

Additional relevant MeSH terms:

Premature Birth; Depression, Postpartum; Birth Weight; Body Weight; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Puerperal Disorders; Depressive Disorder; Mood Disorders; Mental Disorders