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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07560813
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mid-Ohio Food Farmacy (MOF+) produce delivery — DIETARY_SUPPLEMENT
    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) — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
174 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal MedicineColumbusOhio43210-

Find similar trials in Columbus, OH

By condition
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By research site
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine· Columbus, OH

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