Medically tailored groceries to support pregnant people facing food insecurity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.