Premature BirthNCT04845230
Fresh RX: NHS 2020
A study testing FreshRx Nourishing Healthy Starts in people with Premature Birth and Birth Weight, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Birth Weight, Post Partum Depression
- What is being tested?
- FreshRx Nourishing Healthy Starts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2021to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Operation Food Search Inc.
St Louis, Missouri, 63132
Nancy Spargo, MSW, 314-750-4077, nancy.spargo@operationfoodsearch.org
Stephen Roll, PhD
About this study
Official title: Fresh RX: Nourishing Healthy Starts Clinical 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 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.
Read the 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.
- Conditions
- Premature Birth, Birth Weight, Post Partum Depression, Health Care Utilization, Nutrition Deficiency Due to Insufficient Food, Housing Problems
- Being tested
- FreshRx Nourishing Healthy Starts
- Keywords
- food insecurity, pregnancy, maternal health, neonatal health, birth outcomes, poverty, health care utilization, field experiment, integrative care
- Medical subject headings
- Premature Birth, Birth Weight, Depression, Postpartum, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreshRx Nourishing Healthy StartsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | Active comparator | 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. Receives: Behavioral: FreshRx Nourishing Healthy Starts |
| Treatment 1: Nutrition Services | Experimental | 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. Receives: Behavioral: FreshRx Nourishing Healthy Starts |
| Treatment 2: Integrated Care Services | Experimental | 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. Receives: Behavioral: FreshRx Nourishing Healthy Starts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in food insecurity
Repeated measures of food insecurity using United States Department of Agriculture (USDA) food insecurity screener
Measured: 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
Measured: Collected at time of birth
Birthweight
Weight (in grams) of infant at birth
Measured: Collected at time of birth
Secondary outcomes (38)
Change in food spending
A continuous measure asking about weekly expenditures on groceries and eating and restaurants, and other food options
Measured: 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
Measured: 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
Measured: Collected quarterly from enrollment through birth
Maternal Immunizations Received
Pregnancy-related immunizations received (e.g., Tdap, influenza) during pregnancy
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Collected quarterly from enrollment through birth
Maternal Anemia Diagnosis
Incidence of maternal anemia diagnosis at any point during pregnancy
Measured: 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
Measured: Collected quarterly from enrollment through birth
Hypertensive Disorder Diagnosis
Incidence of any hypertensive disorder diagnosis at any point during pregnancy
Measured: Collected quarterly from enrollment through birth
Spontaneous Preterm Labor
Incidence of spontaneous preterm labor at any point during pregnancy
Measured: Collected quarterly from enrollment through birth
Preeclampsia Diagnosis
Incidence of preeclampsia diagnosis at any point during pregnancy
Measured: Collected quarterly from enrollment through birth
Difficulty paying bills
A single item measure capturing the incidence of bill payment difficulty in a typical month
Measured: 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
Measured: 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
Measured: Collected quarterly from enrollment through birth
Spontaneous Abortion
Incidence of spontaneous abortion over course of pregnancy
Measured: Collected quarterly from enrollment through birth
Postpartum Complications
Incidence of common postpartum physical health complications (e.g., hypertension, sepsis)
Measured: Birth through 60 days post-partum
Adverse Post-Partum Mental Health Diagnoses
Incidence of common postpartum adverse mental health diagnoses (e.g., anxiety, psychosis)
Measured: Birth through 60 days post-partum
Maternal Mortality
Incidence of maternal mortality
Measured: Birth through 60 days post-partum
Infant mortality
Incidence of infant mortality
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Collected quarterly from enrollment through one year post-partum
Maternal Emergency Room Visits
Measure of emergency room visits derived from health care claims data
Measured: Collected quarterly from enrollment through one year post-partum
Maternal Wellness Visits
Measure of wellness visits derived from health care claims data
Measured: Collected quarterly from enrollment through one year post-partum
Pediatric Visits
Number of pediatric visits in the post-partum period
Measured: Birth through one year post-partum
Infant Adverse Health Diagnoses
Incidence of common infant adverse health diagnoses (e.g., colic, jaundice)
Measured: Birth through one year post-partum
Days in Neonatal Intensive Care Unit (NICU)
Length of NICU stay for infant following birth
Measured: Collected from birth through 60 days post-partum
Admission to Special Care Nursery
Incidence of admission to special care nursery
Measured: Collected from birth through 60 days post-partum
Birth Defects
Incidence of common birth defects (e.g., congenital heart defects, cleft palate)
Measured: Collected from birth through 60 days post-partum
Child Weight
Child weight (grams) post-birth
Measured: Collected from birth through one year post-partum
Child Height
Child height (centimeters) post-birth
Measured: Collected from birth through one year post-partum
Child Hospital Admissions
Number of Hospital Admissions for Child Following Birth
Measured: Collected from birth through one year post-partum
Neonatal death
Incidence of neonatal death
Measured: Collected from birth through one year post-partum
Child Emergency Department Admissions
Number of emergency department admissions following birth
Measured: Collected from birth through one year post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start9 Aug 2021
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a three-arm experiment where each arm iteratively adds additional program components (see study description for more detail).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Operation Food Search Inc.
- Responsible party
- Sponsor
- Investigators
- Stephen Roll, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845230
- Sponsor's protocol ID
- 202011018
- Status last verified
- Nov 2022
- First submitted
- 29 Mar 2021
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fresh RX: Nourishing Healthy Starts Clinical Study
- ClinicalTrials.gov ID
- NCT04845230
- Acronym / sponsor ID
- 202011018
- Conditions
- Premature Birth, Birth Weight, Post Partum Depression, Health Care Utilization, Nutrition Deficiency Due to Insufficient Food, Housing Problems
- Keywords
- food insecurity, pregnancy, maternal health, neonatal health, birth outcomes, poverty, health care utilization, field experiment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Operation Food Search Inc.
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a three-arm experiment where each arm iteratively adds additional program components (see study description for more detail).
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | Active comparator | Behavioral: FreshRx Nourishing Healthy StartsThe 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: Nutrition Services | Experimental | Behavioral: FreshRx Nourishing Healthy StartsThis 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: Integrated Care Services | Experimental | Behavioral: FreshRx Nourishing Healthy StartsThis 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. |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FreshRx Nourishing Healthy StartsThis 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. | Behavioural | Enhanced Usual Care, Treatment 1: Nutrition Services, Treatment 2: Integrated Care Services |
Primary outcome
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
Gestational Age at Birth
Time frame: Collected at time of birth
Estimated gestational age (in days) of the child on the delivery date
Birthweight
Time frame: Collected at time of birth
Weight (in grams) of infant at birth
38 secondary outcomes
Change in food spending
Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Change in self reported physical and mental health
Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Number of Prenatal Appointments
Time frame: Collected quarterly from enrollment through birth
Maternal Immunizations Received
Time frame: Collected quarterly from enrollment through birth
Change in Maternal Platelet Count
Time frame: Collected quarterly from enrollment through birth
Change in Maternal White Blood Cell Count
Time frame: Collected quarterly from enrollment through birth
Change in Maternal Hematocrit Count
Time frame: Collected quarterly from enrollment through birth
Change in Maternal Hemoglobin Count
Time frame: Collected quarterly from enrollment through birth
Change in Maternal Red Blood Cell Count
Time frame: Collected quarterly from enrollment through birth
Maternal Anemia Diagnosis
Time frame: Collected quarterly from enrollment through birth
Fetal Complications Diagnosis
Time frame: Collected quarterly from enrollment through birth
Hypertensive Disorder Diagnosis
Time frame: Collected quarterly from enrollment through birth
Spontaneous Preterm Labor
Time frame: Collected quarterly from enrollment through birth
Preeclampsia Diagnosis
Time frame: Collected quarterly from enrollment through birth
Difficulty paying bills
Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Post-partum depression
Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Intrauterine Fetal Demise (IUFD)
Time frame: Collected quarterly from enrollment through birth
Spontaneous Abortion
Time frame: Collected quarterly from enrollment through birth
Postpartum Complications
Time frame: Birth through 60 days post-partum
Adverse Post-Partum Mental Health Diagnoses
Time frame: Birth through 60 days post-partum
Maternal Mortality
Time frame: Birth through 60 days post-partum
Infant mortality
Time frame: Birth through 60 days post-partum
Change in food quality
Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Emergency liquidity
Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Public program participation
Time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
Maternal Hospital Admissions
Time frame: Collected quarterly from enrollment through one year post-partum
Maternal Emergency Room Visits
Time frame: Collected quarterly from enrollment through one year post-partum
Maternal Wellness Visits
Time frame: Collected quarterly from enrollment through one year post-partum
Pediatric Visits
Time frame: Birth through one year post-partum
Infant Adverse Health Diagnoses
Time frame: Birth through one year post-partum
Days in Neonatal Intensive Care Unit (NICU)
Time frame: Collected from birth through 60 days post-partum
Admission to Special Care Nursery
Time frame: Collected from birth through 60 days post-partum
Birth Defects
Time frame: Collected from birth through 60 days post-partum
Child Weight
Time frame: Collected from birth through one year post-partum
Child Height
Time frame: Collected from birth through one year post-partum
Child Hospital Admissions
Time frame: Collected from birth through one year post-partum
Neonatal death
Time frame: Collected from birth through one year post-partum
Child Emergency Department Admissions
Time frame: Collected from birth through one year post-partum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Roll, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreshRx Nourishing Healthy Starts in people with Premature Birth and Birth Weight, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Roll, PhD (314-935-3710, stephen.roll@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in food insecurity (time frame: Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022; AzTrials last refreshed its copy on 27 Oct 2026.