NCT06965530

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

The Role of Medically Tailored Groceries in Mitigating Food Insecurity and Improving Pregnancy Outcomes Through Clinic-Community Partnerships

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Medically tailored groceries (MTG) generally involve fresh and shelf-stable grocery items to be prepared at home, selected by a nutritional professional based on a treatment plan and are typically picked up at a clinic, market, or pantry. This clinic-based market or pantry model (CB-MTG) is a growing approach adopted by health care systems in their effort to address food insecurity in their patient population, including University Hospitals of Cleveland (UH) and MetroHealth Medical Center (Metro), two of the three largest health systems in Cleveland, Ohio. Often offered to patients with food-related chronic conditions, CB-MTGs have shown to improve medication adherence, increase fruits and vegetable consumption and decrease HbA1c in people with diabetes. However, less evidence is available on the impact of CB-MTGs with food insecure pregnant individuals, where food insecurity has been strongly associated with prematurity and other negative birth outcomes. While promising, the CB-MTG approach requires transportation, having the tools and equipment to prepare meals at home and some basic food preparation skills, all potential barriers for low-income pregnant individuals, especially younger parents-to-be or those already with children. The Greater Cleveland Food Bank and partners, seeking to address these barriers, recently developed a home delivered version of MTG (HD-MTG), offered to Medicaid-eligible pregnant individuals across the county, with promising results. The investigators seek to integrate these approaches into patient care for food insecure, pregnant women and test the effectiveness of these two approaches, alongside an additional intervention arm that adds supplemental nutrition and culinary education and support to the home-delivered approach (HD-MTG PLUS). These three approaches will be offered (via randomization) to 360 pregnant individuals (120 per arm) with food insecurity who are patients within UH and Metro's largest urban obstetric practices, each with direct electronic health record (EHR) referral systems to their "food as medicine" clinics/markets. Data are collected at baseline, near/at delivery and 6 months post-delivery. This study seeks to understand the unique contribution of each approach, as well as implementation and intervention uptake barriers, with the goal of building the evidence base of MTG interventions and making recommendations to providers and health systems seeking to address food insecurity and nutrient deficiencies during pregnancy.

Conditions

• Pregnancy Related
• Prematurity
• Birth Outcome, Adverse

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	Home Delivered Medically Tailored Groceries (HD-MTG)	Patient receive home delivered medically tailored groceries every two weeks during pregnancy and up to 6 months post-delivery.
DIETARY_SUPPLEMENT	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 6 months post-delivery, plus also receives additional nutrition and culinary education and support throughout the trial.

Timeline

• Start date: 2025-10-06
• Primary completion: 2028-11-01
• Completion: 2029-05-31
• First posted: 2025-05-11
• Last updated: 2025-10-21

Locations

2 sites across 1 country: United States