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Recruiting NCT06965530

NCT06965530 Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy

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Clinical Trial Summary
NCT ID NCT06965530
Status Recruiting
Phase
Sponsor Case Western Reserve University
Condition Pregnancy Related
Study Type INTERVENTIONAL
Enrollment 360 participants
Start Date 2025-11-12
Primary Completion 2028-11-01

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age 55 Years
Study Type INTERVENTIONAL
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)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 360 participants in total. It began in 2025-11-12 with a primary completion date of 2028-11-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility 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

Contact & Investigator

Central Contact

Samantha Bentley, MPH

✉ sxb1213@case.edu

📞 216-368-1024

Principal Investigator

Elaine A Borawski, PhD

PRINCIPAL INVESTIGATOR

Case Western Reserve University

Frequently Asked Questions

Who can join the NCT06965530 clinical trial?

This trial is open to female participants only, aged 18 Years or older, up to 55 Years, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06965530 currently recruiting?

Yes, NCT06965530 is actively recruiting participants. Contact the research team at sxb1213@case.edu for enrollment information.

Where is the NCT06965530 trial being conducted?

This trial is being conducted at Cleveland, United States, Cleveland, United States.

Who is sponsoring the NCT06965530 clinical trial?

NCT06965530 is sponsored by Case Western Reserve University. The principal investigator is Elaine A Borawski, PhD at Case Western Reserve University. The trial plans to enroll 360 participants.

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