Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy
Purpose
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.
Conditions
- Pregnancy Related
- Prematurity
- Birth Outcome, Adverse
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Double (Care Provider, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 6 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 6 months post-delivery, but receives additional nutrition and culinary education and support throughout the trial. |
|
Recruiting Locations
Cleveland 5150529, Ohio 5165418 44106
More Details
- Status
- Recruiting
- Sponsor
- Case Western Reserve University
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.