Fresh Rx: Nourishing Healthy Starts for Pregnant Women

This study, called Fresh Rx: NHS 2020, is testing a program designed to help pregnant women who have trouble getting enough food. The program, called FreshRx Nourishing Healthy Starts, offers referrals to public food programs, direct food delivery, nutrition education, and support from a social worker. Researchers want to see if this program can improve health for both mothers and babies, specifically looking at changes in food insecurity, gestational age (how far along the pregnancy is at birth), and birth weight. You might be able to join if you are a pregnant woman between 14 and 55 years old, less than 24 weeks pregnant, live in certain Missouri zip codes, speak English, and screen positive for food insecurity. The study aims to enroll 750 participants.

Study design
This is an interventional field experiment study, meaning participants will receive different levels of the FreshRx Nourishing Healthy Starts program. Participants will be randomly assigned to one of three groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure food insecurity at the start, around 3 months later, 60 days after birth, and one year after birth. Gestational age and birth weight will be collected at the time of birth.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04845230

Fresh RX: NHS 2020

Recruiting
NAAges 14–55InterventionalPrevention
Washington University School of Medicine
~750 participants
Updated 2022-11-29 on ClinicalTrials.gov
What's tested:FreshRx Nourishing Healthy Starts

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in food insecurity
Measured over Baseline, around 3 months post-baseline, 60 days post-partum, one year post-partum
+2 more outcomes measured
Premature Birth
Birth Weight
Post Partum Depression
Health Care Utilization
Nutrition Deficiency Due to Insufficient Food
Housing Problems
Fetal Complications
Food Deprivation
1 sites across 1 states
Missouri1
  • Stephen Roll, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

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Eligibility criteria

Inclusion

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

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
  • Change in food insecurityBaseline, 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 BirthCollected at time of birth

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

  • BirthweightCollected at time of birth

    Weight (in grams) of infant at birth