Medically tailored groceries to support pregnant people facing food insecurity
The Role of Medically Tailored Groceries in Mitigating Food Insecurity and Improving Pregnancy Outcomes Through Clinic-Community Partnerships
This project will test whether home-delivered medically tailored groceries, with or without extra food education, help Medicaid-eligible pregnant people in Cuyahoga County improve nutrition and birth outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Case Western Reserve University Academic / other |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Trial ID | NCT06965530 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study compares three approaches: clinic-based medically tailored groceries (picked up at clinic/pantry), home-delivered medically tailored groceries, and home-delivered groceries plus supplemental education and support. Eligible Medicaid-insured pregnant people (18+, singleton pregnancy between 10 and 22 weeks) who are established patients at University Hospitals or MetroHealth in Cuyahoga County will be enrolled and followed for behavioral, food-literacy, and birth outcome measures. The interventions provide fresh and shelf-stable foods selected by nutrition professionals, with the HD-MTG arms removing transportation barriers and the HD-MTG_PLUS arm adding targeted education to improve food preparation and use. Results will compare uptake, dietary behaviors, and maternal and neonatal outcomes across the three arms.
Who should consider this trial
Good fit: Ideal candidates are Medicaid-eligible, English-speaking pregnant people aged 18 or older with a singleton pregnancy between 10 and 22 weeks who are established patients at University Hospitals or MetroHealth and live in Cuyahoga County, Ohio.
Not a fit: People under 18, those without Medicaid coverage, non-English speakers, those living outside Cuyahoga County, people with multiple gestations, or those not established at the participating clinics are ineligible and unlikely to benefit from these interventions.
Why it matters
Potential benefit: If successful, this approach could reduce food insecurity, improve maternal nutrition, and lower rates of preterm birth and other adverse birth outcomes among low-income pregnant people.
How similar studies have performed: Clinic-based medically tailored grocery programs have shown benefits in adults with chronic conditions (improved medication adherence, increased fruit and vegetable intake, and lower HbA1c), while home-delivery models have promising early results but limited evidence specifically in pregnant populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cleveland, Ohio and 1 other locations
- MetroHealth Medical Center — Cleveland, Ohio, United States (Recruiting)
- University Hospitals Rainbow Ahuja Women and Children's Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Elaine A Borawski, PhD — Case Western Reserve University
- Study coordinator: Samantha Bentley, MPH
- Email: sxb1213@case.edu
- Phone: 216-368-1024
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.