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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Ohio
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
RECRUITING
Columbus
Time Frame
Start Date: 2026-07-06
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 174
Treatments
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.
Sponsors
Collaborators: University of Michigan
Leads: Ohio State University

This content was sourced from clinicaltrials.gov