Recruiting

Medically Tailored Groceries

Sponsor:

Case Western Reserve University

Code:

NCT06965530

Conditions

Pregnancy Related

Prematurity

Birth Outcome, Adverse

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Clinic-Based Medically Tailored Groceries (CB-MTG)

Home Delivered Medically Tailored Groceries (HD-MTG)

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

Study Details

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.

Conditions

Pregnancy Related

Prematurity

Birth Outcome, Adverse

Study ID

NCT06965530

Start date

Nov 12, 2025

Status verified date

Apr, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • Under 18 years old

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Clinic-Based Medically Tailored Groceries (CB-MTG)

Standard of Care: Patients enrolled in the health systems clinic-based Food is Medicine Program.

experimental: Home Delivered Medically Tailored Groceries (HD-MTG)

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

experimental: Home Delivered Medically Tailored Groceries PLUS (HD-MTGPLUS)

Same 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

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.

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.

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.

Primary outcome measure

  • Food Insecurity [ Time Frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy) ]
  • Food Insecurity [ Time Frame: Change from baseline to 6-months post delivery ]
  • Baby Gestational Age [ Time Frame: At birth ]
  • Baby Birthweight [ Time Frame: At birth ]
  • Days Hospitalized (Baby) [ Time Frame: 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 [ Time Frame: From admission date to the NICU/SCN until the date of discharge from NICU/SCN, assessed up to 100 months ]

Central Contacts and Locations

Central contacts

Samantha Bentley, MPH

216-368-1024sxb1213@case.edu

Elaine A Borawski, PhD

216-368-1024exb11@case.edu

Locations

MetroHealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Kelly Gibson, MD

216-778-7076kgibson@metrohealth.org

University Hospitals Rainbow Ahuja Women and Children's Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Christopher Nau, MD

216-844-1000Christopher.Nau@uhhospitals.org

More Information

Sponsor

Case Western Reserve University

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

  • Randomized trial
  • Behavioral intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-04-20.