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Fresh RX: NHS 2020

Primary Purpose

Premature Birth, Birth Weight, Post Partum Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FreshRx Nourishing Healthy Starts
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Birth focused on measuring food insecurity, pregnancy, maternal health, neonatal health, birth outcomes, poverty, health care utilization, field experiment, integrative care

Eligibility Criteria

14 Years - 55 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Operation Food Search Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Enhanced Usual Care

Treatment 1: Nutrition Services

Treatment 2: Integrated Care Services

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in food insecurity
Repeated measures of food insecurity using United States Department of Agriculture (USDA) food insecurity screener
Gestational Age at Birth
Estimated gestational age (in days) of the child on the delivery date
Birthweight
Weight (in grams) of infant at birth

Secondary Outcome Measures

Change in food spending
A continuous measure asking about weekly expenditures on groceries and eating and restaurants, and other food options
Change in self reported physical and mental health
Measures captured using an abbreviated 5-item Patient Reported Outcomes Measurement Information System (PROMIS) screener
Number of Prenatal Appointments
Number of prenatal health appointments received during pregnancy
Maternal Immunizations Received
Pregnancy-related immunizations received (e.g., Tdap, influenza) during pregnancy
Change in Maternal Platelet Count
Change in lab results on platelet count from first prenatal visit to final prenatal visit
Change in Maternal White Blood Cell Count
Change in lab results on while blood cell count from first prenatal visit to final prenatal visit
Change in Maternal Hematocrit Count
Change in lab results on maternal hematocrit count from first prenatal visit to final prenatal visit
Change in Maternal Hemoglobin Count
Change in lab results on maternal hemoglobin count from first prenatal visit to final prenatal visit
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
Maternal Anemia Diagnosis
Incidence of maternal anemia diagnosis at any point during pregnancy
Fetal Complications Diagnosis
Incidence of any common fetal complication diagnosis (e.g., ectopic pregnancy) at any point during pregnancy
Hypertensive Disorder Diagnosis
Incidence of any hypertensive disorder diagnosis at any point during pregnancy
Spontaneous Preterm Labor
Incidence of spontaneous preterm labor at any point during pregnancy
Preeclampsia Diagnosis
Incidence of preeclampsia diagnosis at any point during pregnancy
Difficulty paying bills
A single item measure capturing the incidence of bill payment difficulty in a typical month
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
Intrauterine Fetal Demise (IUFD)
Incidence of IUFD over course of pregnancy
Spontaneous Abortion
Incidence of spontaneous abortion over course of pregnancy
Postpartum Complications
Incidence of common postpartum physical health complications (e.g., hypertension, sepsis)
Adverse Post-Partum Mental Health Diagnoses
Incidence of common postpartum adverse mental health diagnoses (e.g., anxiety, psychosis)
Maternal Mortality
Incidence of maternal mortality
Infant mortality
Incidence of infant mortality
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
Emergency liquidity
A single item indicator capturing how participants would cover a $400 emergency expense
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
Maternal Hospital Admissions
Measure of hospital admissions derived from health care claims data
Maternal Emergency Room Visits
Measure of emergency room visits derived from health care claims data
Maternal Wellness Visits
Measure of wellness visits derived from health care claims data
Pediatric Visits
Number of pediatric visits in the post-partum period
Infant Adverse Health Diagnoses
Incidence of common infant adverse health diagnoses (e.g., colic, jaundice)
Days in Neonatal Intensive Care Unit (NICU)
Length of NICU stay for infant following birth
Admission to Special Care Nursery
Incidence of admission to special care nursery
Birth Defects
Incidence of common birth defects (e.g., congenital heart defects, cleft palate)
Child Weight
Child weight (grams) post-birth
Child Height
Child height (centimeters) post-birth
Child Hospital Admissions
Number of Hospital Admissions for Child Following Birth
Neonatal death
Incidence of neonatal death
Child Emergency Department Admissions
Number of emergency department admissions following birth

Full Information

First Posted
March 29, 2021
Last Updated
November 27, 2022
Sponsor
Washington University School of Medicine
Collaborators
Operation Food Search Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04845230
Brief Title
Fresh RX: NHS 2020
Official Title
Fresh RX: Nourishing Healthy Starts Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2021 (Actual)
Primary Completion Date
September 15, 2025 (Anticipated)
Study Completion Date
September 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Operation Food Search Inc.

4. Oversight

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

5. 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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
This is a three-arm experiment where each arm iteratively adds additional program components (see study description for more detail).
Masking
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.
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment 1: Nutrition Services
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment 2: Integrated Care Services
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
FreshRx Nourishing Healthy Starts
Intervention Description
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 Outcome Measure Information:
Title
Change in food insecurity
Description
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
Title
Gestational Age at Birth
Description
Estimated gestational age (in days) of the child on the delivery date
Time Frame
Collected at time of birth
Title
Birthweight
Description
Weight (in grams) of infant at birth
Time Frame
Collected at time of birth
Secondary Outcome Measure Information:
Title
Change in food spending
Description
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
Title
Change in self reported physical and mental health
Description
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
Title
Number of Prenatal Appointments
Description
Number of prenatal health appointments received during pregnancy
Time Frame
Collected quarterly from enrollment through birth
Title
Maternal Immunizations Received
Description
Pregnancy-related immunizations received (e.g., Tdap, influenza) during pregnancy
Time Frame
Collected quarterly from enrollment through birth
Title
Change in Maternal Platelet Count
Description
Change in lab results on platelet count from first prenatal visit to final prenatal visit
Time Frame
Collected quarterly from enrollment through birth
Title
Change in Maternal White Blood Cell Count
Description
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
Title
Change in Maternal Hematocrit Count
Description
Change in lab results on maternal hematocrit count from first prenatal visit to final prenatal visit
Time Frame
Collected quarterly from enrollment through birth
Title
Change in Maternal Hemoglobin Count
Description
Change in lab results on maternal hemoglobin count from first prenatal visit to final prenatal visit
Time Frame
Collected quarterly from enrollment through birth
Title
Change in Maternal Red Blood Cell Count
Description
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
Title
Maternal Anemia Diagnosis
Description
Incidence of maternal anemia diagnosis at any point during pregnancy
Time Frame
Collected quarterly from enrollment through birth
Title
Fetal Complications Diagnosis
Description
Incidence of any common fetal complication diagnosis (e.g., ectopic pregnancy) at any point during pregnancy
Time Frame
Collected quarterly from enrollment through birth
Title
Hypertensive Disorder Diagnosis
Description
Incidence of any hypertensive disorder diagnosis at any point during pregnancy
Time Frame
Collected quarterly from enrollment through birth
Title
Spontaneous Preterm Labor
Description
Incidence of spontaneous preterm labor at any point during pregnancy
Time Frame
Collected quarterly from enrollment through birth
Title
Preeclampsia Diagnosis
Description
Incidence of preeclampsia diagnosis at any point during pregnancy
Time Frame
Collected quarterly from enrollment through birth
Title
Difficulty paying bills
Description
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
Title
Post-partum depression
Description
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
Title
Intrauterine Fetal Demise (IUFD)
Description
Incidence of IUFD over course of pregnancy
Time Frame
Collected quarterly from enrollment through birth
Title
Spontaneous Abortion
Description
Incidence of spontaneous abortion over course of pregnancy
Time Frame
Collected quarterly from enrollment through birth
Title
Postpartum Complications
Description
Incidence of common postpartum physical health complications (e.g., hypertension, sepsis)
Time Frame
Birth through 60 days post-partum
Title
Adverse Post-Partum Mental Health Diagnoses
Description
Incidence of common postpartum adverse mental health diagnoses (e.g., anxiety, psychosis)
Time Frame
Birth through 60 days post-partum
Title
Maternal Mortality
Description
Incidence of maternal mortality
Time Frame
Birth through 60 days post-partum
Title
Infant mortality
Description
Incidence of infant mortality
Time Frame
Birth through 60 days post-partum
Title
Change in food quality
Description
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
Title
Emergency liquidity
Description
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
Title
Public program participation
Description
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
Title
Maternal Hospital Admissions
Description
Measure of hospital admissions derived from health care claims data
Time Frame
Collected quarterly from enrollment through one year post-partum
Title
Maternal Emergency Room Visits
Description
Measure of emergency room visits derived from health care claims data
Time Frame
Collected quarterly from enrollment through one year post-partum
Title
Maternal Wellness Visits
Description
Measure of wellness visits derived from health care claims data
Time Frame
Collected quarterly from enrollment through one year post-partum
Title
Pediatric Visits
Description
Number of pediatric visits in the post-partum period
Time Frame
Birth through one year post-partum
Title
Infant Adverse Health Diagnoses
Description
Incidence of common infant adverse health diagnoses (e.g., colic, jaundice)
Time Frame
Birth through one year post-partum
Title
Days in Neonatal Intensive Care Unit (NICU)
Description
Length of NICU stay for infant following birth
Time Frame
Collected from birth through 60 days post-partum
Title
Admission to Special Care Nursery
Description
Incidence of admission to special care nursery
Time Frame
Collected from birth through 60 days post-partum
Title
Birth Defects
Description
Incidence of common birth defects (e.g., congenital heart defects, cleft palate)
Time Frame
Collected from birth through 60 days post-partum
Title
Child Weight
Description
Child weight (grams) post-birth
Time Frame
Collected from birth through one year post-partum
Title
Child Height
Description
Child height (centimeters) post-birth
Time Frame
Collected from birth through one year post-partum
Title
Child Hospital Admissions
Description
Number of Hospital Admissions for Child Following Birth
Time Frame
Collected from birth through one year post-partum
Title
Neonatal death
Description
Incidence of neonatal death
Time Frame
Collected from birth through one year post-partum
Title
Child Emergency Department Admissions
Description
Number of emergency department admissions following birth
Time Frame
Collected from birth through one year post-partum
Other Pre-specified Outcome Measures:
Title
Change in cooking skills
Description
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.
Time Frame
Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study is an evaluation of a program that provides food and nutrition supports to food insecure pregnant women.
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Roll, PhD
Phone
314-935-3710
Email
stephen.roll@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kourtney Gilbert, MSW
Phone
314-935-8142
Email
kgilbert@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Roll, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Operation Food Search Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Spargo, MSW
Phone
314-750-4077
Email
nancy.spargo@operationfoodsearch.org
First Name & Middle Initial & Last Name & Degree
Stephen Roll, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Fresh RX: NHS 2020

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