360 Participants Needed

Medically Tailored Groceries for Pregnancy

Recruiting at 2 trial locations
SB
EA
Overseen ByElaine A Borawski, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Case Western Reserve University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Medically tailored groceries (MTG), involving grocery items to be prepared at home, selected by a nutritional professional based on a treatment plan, is a growing approach adopted by healthcare systems to address food insecurity in their patient populations, a leading contribution to health disparities such as poor birth outcomes within pregnant populations. However, transportation and other social needs can often hinder patient uptake of clinic-based approaches. Findings from this study will help to better understand how home delivery of MTGs, with and without supplemental education and support to improve food literacy, behavioral and health outcomes.

Research Team

EA

Elaine A Borawski, PhD

Principal Investigator

Case Western Reserve University

Eligibility Criteria

This trial is for pregnant individuals facing food insecurity, which can lead to complications during pregnancy and at birth. It's designed to see if getting groceries chosen by nutrition experts helps improve their health outcomes.

Inclusion Criteria

I am pregnant, between 10 and 22 weeks along, and can consent by 20 weeks.
Eligible for Medicaid
Singleton pregnancy, confirmed by ultrasound
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medically tailored groceries, either clinic-based or home-delivered, with or without additional nutrition and culinary education, throughout pregnancy and up to 6 months post-delivery

Up to 40 weeks of pregnancy and 6 months post-delivery
Bi-weekly home deliveries

Follow-up

Participants are monitored for dietary quality, healthy eating index, and other health outcomes post-delivery

6 months post-delivery

Treatment Details

Interventions

  • Medically Tailored Groceries
Trial Overview The study tests three approaches: home delivery of medically tailored groceries (HD-MTG), clinic-based pickup of these groceries (CB-MTG), and home delivery with additional education on food preparation and nutrition (HD-MTG_PLUS).
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Home Delivered Medically Tailored Groceries PLUS (HD-MTGPLUS)Experimental Treatment1 Intervention
Same as Arm 2, receiving home delivered medically tailored groceries every two weeks during pregnancy and up to 6 months post-delivery, but receives additional nutrition and culinary education and support throughout the trial.
Group II: Home Delivered Medically Tailored Groceries (HD-MTG)Experimental Treatment1 Intervention
Patient received home delivered medically tailored groceries every two weeks during pregnancy and up to 6 months post-delivery.
Group III: Clinic-Based Medically Tailored Groceries (CB-MTG)Active Control1 Intervention
Standard of Care: Patients enrolled in the health systems clinic-based Food is Medicine Program.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials
314
Recruited
236,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+

University Hospitals Cleveland Medical Center

Collaborator

Trials
348
Recruited
394,000+

MetroHealth Medical Center

Collaborator

Trials
125
Recruited
22,600+

Greater Cleveland Food Bank

Collaborator

Trials
1
Recruited
120+
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