NOURISH: a community partnership to improve nutrition and glycemic control in pregnant women with pregestational diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

NOURISH tests a scalable, theory-based program that combines weekly produce delivery with clinic-based nutrition and culinary education and ongoing social needs support for high-risk pregnant women with pregestational diabetes and food insecurity. The intervention links a Farmacy produce delivery service with diabetes education and resources to address social barriers to healthy eating. Eligible participants are adults with singleton or multiple gestations, gestational age between 8+0 and 22+6 weeks, and A1c criteria, who screen positive for food insecurity and can participate in the MOF+ program. The study is led by Ohio State University with collaboration from the University of Michigan and is conducted at Ohio State Wexner Medical Center. Outcomes of interest include glycemic control and pregnancy outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Daniel Walker, PhD — Ohio State University

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.