Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy
The Role of Medically Tailored Groceries in Mitigating Food Insecurity and Improving Pregnancy Outcomes Through Clinic-Community Partnerships
2 other identifiers
interventional
360
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2025
CompletedFirst Posted
Study publicly available on registry
May 11, 2025
CompletedStudy Start
First participant enrolled
November 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2029
April 20, 2026
April 1, 2026
3 years
April 11, 2025
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Food Insecurity
6 item, United States Department of Agriculture (USDA) measure; dichotomous outcome
Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
Food Insecurity
6 item, USDA measure; dichotomous outcome
Change from baseline to 6-months post delivery
Baby Gestational Age
Measured in weeks and classified as preterm (\<37 weeks) vs. term (37+ weeks)
At birth
Baby Birthweight
Measured in grams and classified as normal (\> or = 2500g), low birth weight (\<2500g), very low birthweight (\<1500g), extremely low birth weight (\<1000g)
At birth
Days Hospitalized (Baby)
Number of days baby was hospitalized following birth
From date of birth until the date of discharge from the hospital, assessed up to 100 months
Neonatal Intensive Care Unit (NICU)/Special Care Nursery (SCN) Utilization
Number of days baby was admitted to NICU or SCN
From admission date to the NICU/SCN until the date of discharge from NICU/SCN, assessed up to 100 months
Secondary Outcomes (24)
Birth Complications
Perioperative/periprocedural
Prenatal Health Care
From first documented prenatal visit until the baby's delivery date, assessed up to 9 months
Pregnancy Complications
Perioperative/periprocedural
Gestational Diabetes Mellitus (GDM)
Assessed up to 40 weeks of pregnancy
Attitudes toward Cooking and Food Preparation
Change from baseline to delivery (assessed up to 40 weeks of pregnancy)
- +19 more secondary outcomes
Study Arms (3)
Clinic-Based Medically Tailored Groceries (CB-MTG)
ACTIVE COMPARATORStandard of Care: Patients enrolled in the health systems clinic-based Food is Medicine Program.
Home Delivered Medically Tailored Groceries (HD-MTG)
EXPERIMENTALPatient received home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery.
Home Delivered Medically Tailored Groceries PLUS (HD-MTGPLUS)
EXPERIMENTALSame as Arm 2, receiving home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery, but receives additional nutrition and culinary education and support throughout the trial.
Interventions
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.
Patient receive home delivered medically tailored groceries every two weeks during pregnancy and up to 3 months post-delivery.
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.
Eligibility Criteria
You may qualify if:
- years of age and older
- Pregnant patients \>10 weeks and \<22 weeks gestation at randomization (must be consented by 18 weeks)
- Eligible for Medicaid
- Singleton pregnancy, confirmed by ultrasound
- An established patient of the UH or Metro pregnancy clinic
- English speaking
- Lives in Cuyahoga County, Ohio
You may not qualify if:
- Under 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Case Western Reserve Universitylead
- National Institute of Nursing Research (NINR)collaborator
- MetroHealth Medical Centercollaborator
- University Hospitals Cleveland Medical Centercollaborator
- Greater Cleveland Food Bankcollaborator
Study Sites (2)
MetroHealth Medical Center
Cleveland, Ohio, 44106, United States
University Hospitals Rainbow Ahuja Women and Children's Center
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elaine A Borawski, PhD
Case Western Reserve University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Chair for Applied Research, Department of Nutrition
Study Record Dates
First Submitted
April 11, 2025
First Posted
May 11, 2025
Study Start
November 12, 2025
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
May 31, 2029
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Within 6 months of the primary outcomes paper being published.
As required by our National Institute of Nursing Research grant award, please see the required Data Management and Sharing Plan (uploaded as separate document). In brief, at the of the study, de-identified questionnaire, clinical and implementation data will be deposited into the Inter-university Consortium for Political and Social Research (ICPSR) and designated as controlled access. Case Western Reserve University (CWRU) is a member of ICPSR which permits the deposit of data at no charge.