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

RecruitingNAAges 18 Years - anyFemaleOhio State University
NCT07560813 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 sign

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📋 Eligibility rules (as published)
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.
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What it tests

  • 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
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Where

1 site
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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