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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Western Reserve University
Study ID
NCT06965530
Status
Recruiting
Apply to this trial

Conditions

  • Birth Outcome, Adverse
  • Pregnancy Related
  • Prematurity

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Clinic-Based Medically Tailored Groceries (CB-MTG) — DIETARY_SUPPLEMENT
    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) — DIETARY_SUPPLEMENT
    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) — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

Start date
Nov 12, 2025
Status verified
Apr 2026
Primary completion
Nov 1, 2028
Completion
May 31, 2029

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Food Insecurity [ Time Frame: Change from baseline to delivery (assessed up to 40 weeks of pregnancy) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MetroHealth Medical CenterClevelandOhio44106
Kelly Gibson, MD
[email protected]
216-778-7076
University Hospitals Rainbow Ahuja Women and Children's CenterClevelandOhio44106
Christopher Nau, MD
[email protected]
216-844-1000

Find similar trials in Cleveland, OH

By research site
MetroHealth Medical Center· Cleveland, OHUniversity Hospitals Rainbow Ahuja Women and Children's Center· Cleveland, OH

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