Nutrition Education and Support for Pregestational Diabetes

(NOURISH Trial)

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Ohio State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

DW

Daniel Walker, PhD

Principal Investigator

Ohio State University

KK

Kartik K Venkatesh, MD, PhD

Principal Investigator

Ohio State University

CF

Christine Field, MD, MPH

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

Inclusion Criteria

I started GLP-1 or SGLT2 meds in the past year and had an A1c of 6.5% or higher before starting.
I can speak English or Spanish.
* Type 1 or 2 diabetes.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive weekly nutritious produce home delivery, monthly clinic-integrated diabetes, nutrition, and culinary group education, and continuous social needs assessment and support

Up to 9 months
Weekly home deliveries, monthly in-person group education

Follow-up

Participants are monitored for glycemic control and pregnancy outcomes, including A1c levels and gestational weight gain

6-12 weeks postpartum
Once per trimester, postpartum assessment

What Are the Treatments Tested in This Trial?

Interventions

  • Health Impact Ohio Central Ohio Pathways Hub to address unmet social needs
  • Mid-Ohio Food Farmacy (MOF+) produce delivery
  • Nutrition education with Dining with Diabetes (DWD)

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment3 Interventions
Group II: Standard of careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+