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FreshRx Nourishing Healthy Starts for Malnutrition

N/A

Recruiting

Led By Stephen Roll, PhD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 14-55

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up birth through one year post-partum

Awards & highlights

Study Summary

This trial will test a program that provides food and nutrition support to pregnant women who don't have enough to eat. The goal is to see if this improves health outcomes for mother and child, and if it saves money on healthcare costs.

Who is the study for?

This trial is for pregnant women aged 14-55, less than 24 weeks gestation, living in specific Missouri zip codes. They must be experiencing food insecurity, speak English, and receive care through a Missouri Medicaid managed care organization.Check my eligibility

What is being tested?

The study tests the Fresh Rx: Nourishing Healthy Starts program which provides food support and integrative care services to improve health outcomes for mothers and babies against standard prenatal care.See study design

What are the potential side effects?

Since this intervention involves nutritional support rather than medication, there are no traditional side effects; however, participants may experience changes in diet or lifestyle due to the program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 14 and 55 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected quarterly from enrollment through one year post-partum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected quarterly from enrollment through one year post-partum

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected quarterly from enrollment through one year post-partum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Birthweight

Change in food insecurity

Gestational Age at Birth

Secondary outcome measures

Admission to Special Care Nursery

Adverse Post-Partum Mental Health Diagnoses

Birth Defects

+35 more

Other outcome measures

Change in cooking skills

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Treatment 2: Integrated Care ServicesExperimental Treatment1 Intervention

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.

Group II: Treatment 1: Nutrition ServicesExperimental Treatment1 Intervention

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.

Group III: Enhanced Usual CareActive Control1 Intervention

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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,123 Total Patients Enrolled

37 Trials studying Malnutrition

38,562 Patients Enrolled for Malnutrition

Operation Food Search Inc.UNKNOWN

Stephen Roll, PhDPrincipal InvestigatorWashington University School of Medicine

Media Library

FreshRx Nourishing Healthy Starts Clinical Trial Eligibility Overview. Trial Name: NCT04845230 — N/A

Malnutrition Research Study Groups: Treatment 2: Integrated Care Services, Treatment 1: Nutrition Services, Enhanced Usual Care

Malnutrition Clinical Trial 2023: FreshRx Nourishing Healthy Starts Highlights & Side Effects. Trial Name: NCT04845230 — N/A

FreshRx Nourishing Healthy Starts 2023 Treatment Timeline for Medical Study. Trial Name: NCT04845230 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims does this trial endeavor to achieve?

"This clinical trial aims to assess the impact of the intervention on birthweight. Additionally, it will observe incidences of spontaneous abortion during pregnancy, common congenital defects, and any hypertensive disorder diagnoses throughout gestation."

Answered by AI

May I register to take part in this clinical examination?

"This medical experiment is enrolling 750 individuals aged 14 to 55. The ideal candidate would be a pregnant woman between the ages of 14 and 24 weeks gestation."

Answered by AI

Are there vacancies remaining in this research study?

"The clinical study is currently recruiting, as reflected on the information hosted via clinicaltrials.gov. This trial was posted on August 9th 2021 and edited most recently on November 27th 2022."

Answered by AI

What is the current sample size for this trial?

"Affirmative. The clinical trial information hosted on clinicaltrials.gov demonstrates that the research, which was initially advertised on August 9th 2021, is still recruiting individuals to join it. There are 750 vacancies across one location."

Answered by AI