NOURISH - A Healthcare-community Partnership to Improve Nutrition for Optimal Glycemic Control and Pregnancy Outcomes With Pregestational Diabetes

Summary

Nutrition insecurity (inclusive of food insecurity + poor diet quality) is a fundamental social need that must be addressed to improve treatment and health outcomes for high-risk pregnant women with pregestational type 1 and 2 diabetes, poor glucose control, and food insecurity for whom a healthy diet is critical. The NOURISH trial will provide evidence of a scalable, integrated, and theory-based healthcare-community partnership that includes weekly nutritious produce home delivery, monthly clinic-integrated diabetes, nutrition, and culinary group education, and continuous social needs assessment and support to improve glucose control and pregnancy outcomes. Given the increasing burden and devasting consequences of nutrition insecurity among high-risk pregnant women with diabetes and unmet social needs, NOURISH-an innovative and sustainable healthcare-community partnership-will have significant public health benefit.

Conditions

• Type 2 Diabetes
• Type 1 Diabetes
• Pregnancy, High Risk

Interventions

DIETARY_SUPPLEMENT

Mid-Ohio Food Farmacy (MOF+) produce delivery

The Mid-Ohio Food Collective (MOFC) is a regional foodbank that delivers \>170,000 meals daily through 680 agency partnerships and is ranked as one of the 10 largest in the U.S. Both OSUWMC and MOFC are located in a large metropolitan region in Ohio. OSUWMC offers the Mid-Ohio Farmacy (MOF) referral in 9 clinics, including an integrated diabetes and prenatal care clinic for pregnant individuals with pregestational diabetes. The goal of the MOF is to establish a systematic screening and referral process that connects patients to fresh produce through a food pantry near their home. In NOURISH: The investigators will extend the existing MOF program to weekly home delivery of produce coordinated by the Food Collective. Weekly MOF+ deliveries will include 15 to 20 pounds per week of low to medium glycemic index fruits and vegetables from available inventory, as recommended by the USDA Thrifty Food Plan.

BEHAVIORAL

Nutrition education with Dining with Diabetes (DWD)

The investigators will deploy OSU Extension's community-based education program, DWD, with live programming focused on cooking instruction from the OSU-based Cooking Matters (CM) program, which actively engages participants to develop skills for healthy eating. The investigators have tailored this program to target the specific needs of pregnant women with pregestational diabetes. This includes primarily virtual education sessions with interactive cooking sessions. The nutrition portion focuses on healthy eating and blood glucose management, and the cooking portion provides education on food safety, knife techniques, nutrition facts and ingredients label reading, meal planning, budgeting, and shopping. Content will be adapted from current guidance for pregnant women with diabetes

BEHAVIORAL

Health Impact Ohio Central Ohio Pathways Hub to address unmet social needs

The Pathways Community Hub ('Hub') model consists of three features: (1) the Hub is a regional coordination entity that employs CHWs to assess the medical and social needs of vulnerable patients and connect them to community resources; (2) the CHWs initiate a "care pathway," a defined action plan that describes how patient needs will be addressed, which is then recorded and tracked in an electronic database; and (3) completion of each care pathway is linked to payment from insurance companies (Medicaid-managed care plans and other community partners) based on specific performance benchmarks. Specifically, a financial contract is attached to each standardized care pathway: When a care pathway is completed, a CHW must confirm that a measurable outcome (e.g., patient is assigned to a medical home) is obtained in order to receive an insurance payment.

Sponsors & Collaborators

• Ohio State University

  lead OTHER

Principal Investigators

• Daniel Walker, PhD · Ohio State University

• Kartik K Venkatesh, MD, PhD · Ohio State University

• Christine Field, MD, MPH · Ohio State University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-25

Primary Completion

2030-03-31

Completion

2030-06-30

Countries

• United States

Study Locations