Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy

NCT06965530 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-04-20

No results posted yet for this study

Summary

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.

Conditions

  • Pregnancy Related
  • Prematurity
  • Birth Outcome, Adverse

Interventions

DIETARY_SUPPLEMENT

Clinic-Based Medically Tailored Groceries (CB-MTG)

Patients have the opportunity to pick up medically tailored groceries every other week at the Food Is Medicine Clinic or Market associated with their provider.

DIETARY_SUPPLEMENT

Home Delivered Medically Tailored Groceries (HD-MTG)

Patient receive home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery.

DIETARY_SUPPLEMENT

Home Delivered Medically Tailored Groceries plus Education (HD-MTG_PLUS)

Patients receive home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery, plus also receives additional nutrition and culinary education and support throughout the trial.

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH
  • University Hospitals Cleveland Medical Center

    collaborator OTHER
  • MetroHealth Medical Center

    collaborator OTHER
  • Greater Cleveland Food Bank

    collaborator UNKNOWN
  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Elaine A Borawski, PhD · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-12
Primary Completion
2028-11-01
Completion
2029-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06965530 on ClinicalTrials.gov