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

Case Western Reserve University

Status: Enrolling

Conditions: Prematurity; Pregnancy Related; Birth Outcome, Adverse

Treatments: Dietary Supplement: Home Delivered Medically Tailored Groceries plus Education (HD-MTG_PLUS); Dietary Supplement: Clinic-Based Medically Tailored Groceries (CB-MTG); Dietary Supplement: Home Delivered Medically Tailored Groceries (HD-MTG)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06965530

STUDY20241029

R01NR021490 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age and older
• Pregnant patients >10 weeks and <22 weeks gestation at randomization (must be consented by 20 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 3 patient groups

Clinic-Based Medically Tailored Groceries (CB-MTG)

Active Comparator group

Description:

Standard of Care: Patients enrolled in the health systems clinic-based Food is Medicine Program.

Treatment:

Dietary Supplement: Clinic-Based Medically Tailored Groceries (CB-MTG)

Home Delivered Medically Tailored Groceries (HD-MTG)

Experimental group

Description:

Patient received home delivered medically tailored groceries every two weeks during pregnancy and up to 6 months post-delivery.

Treatment:

Dietary Supplement: Home Delivered Medically Tailored Groceries (HD-MTG)

Home Delivered Medically Tailored Groceries PLUS (HD-MTGPLUS)

Experimental group

Description:

Same as Arm 2, receiving home delivered medically tailored groceries every two weeks during pregnancy and up to 6 months post-delivery, but receives additional nutrition and culinary education and support throughout the trial.

Treatment:

Dietary Supplement: Home Delivered Medically Tailored Groceries plus Education (HD-MTG_PLUS)