174 Participants NeededMy employer runs this trial

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?

This trial aims to assist pregnant women with type 1 or type 2 diabetes who face food insecurity, meaning difficulty accessing enough nutritious food. The researchers seek to determine if weekly home delivery of healthy food, combined with education on managing diabetes and nutrition through the Dining with Diabetes (DWD) program, can enhance pregnancy outcomes. Participants will be divided into two groups: one receiving food deliveries and education, and the other receiving standard care with access to community resources. Ideal candidates for this trial are pregnant women with diabetes who experience food insecurity and can participate in the food delivery program. As an unphased trial, this study provides a unique opportunity to access supportive resources that may improve health outcomes during pregnancy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions specific criteria related to certain diabetes medications, so it's best to discuss your current medications with the trial team.

What prior data suggests that this nutrition education and support program is safe for pregnant women with diabetes?

Research has shown that the treatments in the NOURISH trial are generally safe and well-tolerated. The Mid-Ohio Food Farmacy program, which provides fresh fruits and vegetables to participants, has demonstrated positive health results and is considered safe. This program has been linked to better health for people with diet-related conditions, with no reports of major side effects.

For the nutrition education component, called Dining with Diabetes, studies indicate that this program is safe and beneficial. Participants have experienced improvements in their diabetes health and lifestyle habits, demonstrating that the education effectively manages diabetes without causing harm.

Overall, both the fresh produce delivery and the nutrition education have strong safety records, making them reliable options for improving health in pregnant women with diabetes.12345

Why are researchers excited about this trial?

Unlike the standard care for pregestational diabetes, which typically involves medication and general dietary guidelines, the Dining with Diabetes (DWD) program offers a comprehensive approach by combining nutrition education with direct access to healthy foods. Participants in this trial receive home deliveries of nutritious produce through the Mid-Ohio Farmacy program, which helps ensure they have the resources needed to follow dietary recommendations. Researchers are excited about this approach because it addresses the practical challenges of maintaining a healthy diet during pregnancy, potentially leading to better health outcomes for both the mother and baby.

What evidence suggests that this trial's treatments could be effective for pregestational diabetes?

Research has shown that programs like the Mid-Ohio Farmacy, which provide fresh fruits and vegetables, improve health for people with diabetes. In this trial, the intervention group will receive home delivery of healthy food through the Mid-Ohio Farmacy program. Studies have found that regular access to healthy food can help control blood sugar levels. Additionally, learning about nutrition through programs like Dining with Diabetes is linked to better health and lifestyle changes for people with diabetes. Specifically, pregnant women with diabetes who received nutrition education experienced better pregnancy outcomes. This trial will assess whether combining access to healthy food with nutrition education improves health for pregnant women with diabetes.13467

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?

This trial is for pregnant women age 18 or older with type 1 or type 2 diabetes, who are between about 8 and 23 weeks pregnant, speak English or Spanish, have trouble affording enough healthy food, and are willing to receive home produce deliveries in Central Ohio.

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)

Trial Overview

The study tests a program combining weekly home delivery of fresh produce, monthly group classes on nutrition and diabetes management, and ongoing help with social needs. The goal is to improve blood sugar control and pregnancy outcomes.

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+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

Citations

A Healthcare-community Partnership to Improve Nutrition ...

OSUWMC offers the Mid-Ohio Farmacy (MOF) referral in 9 clinics, including an integrated diabetes and prenatal care clinic for pregnant ...

Mid-Ohio Food Farmacy (MOF+) produce delivery a Nutrition ...

Pregnant women with pregestational diabetes and nutrition insecurity are more likely to experience poor glycemic control, and as a result, adverse pregnancy ...

A Healthcare-community Partnership to Improve Nutrition ...

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

Pregestational Diabetes Mellitus - Endotext - NCBI Bookshelf

In this chapter, we will review the metabolic changes that occur during normal pregnancies and those affected by pregestational diabetes.

Food, community and care | Ohio State College of Medicine

This is the first study to test whether improving access to nutritious food can improve pregnancy outcomes for women living with diabetes. This ...

Nutrition Education and Support for Pregestational ...

Mid-Ohio Food Farmacy (MOF+) produce delivery; Nutrition education with ... At the completion of the study, participants will be encouraged to enroll and utilize ...

Policy Brief: New Study Demonstrates Positive Health ...

Patients referred to the Farmacy program can come once per week to a participating food pantry in central Ohio to pick up fresh produce for themselves and their ...