Recruiting

NOURISH

Sponsor:

Ohio State University

Code:

NCT07560813

Conditions

Type 2 Diabetes

Type 1 Diabetes

Pregnancy, High Risk

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mid-Ohio Food Farmacy (MOF+) produce delivery

Nutrition education with Dining with Diabetes (DWD)

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

Study Details

Brief 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

Study ID

NCT07560813

Start date

Jul 6, 2026

Status verified date

Aug, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Pregnant with singleton or twin pregnancy
  • Gestational age >8+0 to ≤22+6 weeks at enrollment by project EDD
  • Age ≥ 18 years.
  • Type 1 or 2 diabetes.
  • Screen positive for food insecurity based on answering "Often" or "Sometimes" true to either of the two questions on the USDA Hunger Vital Sign screening questions (within 12 months of enrolling in prenatal care).
  • English or Spanish speaking.
  • Willing to participate in Mid-Ohio Farmacy program and able to provide a home address to which food delivery can be provided by the Mid-Ohio Food Collective.
  • Hemoglobin A1c criteria:

  • If not taking glucagon-line peptide-1 (GLP-1) or sodium-glucose co-transporter 2 (SGLT2) medication within 12 months of enrolling in prenatal care, A1c ≥6.5% during this time period.
  • If taking GLP-1 or SGLT2 medication within 12 months of enrolling in prenatal care, A1c≥6.5% during the 12 months prior to initiation of these medications.

Exclusion Criteria

  • Involuntarily confined or detained.
  • Considered as having a diminished decision-making capacity.

Study Design

Enrollment

174 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention group

Participants in the NOURISH intervention group will be enrolled in the Mid-Ohio Farmacy program to receive home delivery of healthy food and produce from the Mid-Ohio Food Collective up to once a week and access to nutrition education and community resources. They may be invited to participate in an optional interview about their experience. Participants will be asked to complete surveys about their diet and nutrition and experiences living with diabetes and pregnancy.

no intervention: Standard of care

Participants in the standard of care group will receive access to community resources to support their diet during pregnancy, be asked to complete surveys about their diet and nutrition and experiences living with diabetes and pregnancy. They may be invited to participate in an optional interview about their experience. Participants will be given access to community resources about nutrition for which they may qualify. At the completion of the study, participants will be encouraged to enroll and utilize the Mid-Ohio Farmacy program.

Interventions

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 nine clinics, including an integrated diabetes and prenatal care clinic for pregnant individuals with pregestational diabetes, with OSUWMC funding secured to continue this program. The goal of the MOF is to establish a systematic screening and referral process aimed at addressing food insecurity 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.

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. Working with our diabetes education team from DWD, the investigators have tailored this program to target the specific needs of pregnant individuals with pregestational diabetes. This includes in-person 1 hour group sessions every 4 weeks (monthly) at the time of clinic visits with alternating education sessions provided by DWD with interactive hands-on cooking sessions provided by CM. 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 state-approved curricula for pregnancy and the American Diabetes Association.

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

Health Impact Ohio Central Ohio Pathways Hub. 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.

Primary outcome measure

  • The primary clinical outcome is the proportion of participants with an A1c <6.5% before delivery. [ Time Frame: Approximately once per trimester every 12-14 weeks betwee trial enrollment through 6-12 weeks postpartum. ]

Central Contacts and Locations

Locations

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Recruiting

Columbus, Ohio, United States, 43210

Contacts

More Information

Sponsor

Ohio State University

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Pregnancy
  • Type 1 Diabetes
  • Type 2 Diabetes
  • food insecurity
  • nutrition insecurity
  • social determinants of health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-08-14.