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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

NOURISH tests whether weekly home deliveries of healthy produce, monthly group classes, and ongoing support for social needs can improve blood sugar and pregnancy outcomes. It is for pregnant adults who had type 1 or type 2 diabetes before pregnancy, have high blood sugar, and have trouble getting enough food.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Pregnant with one baby or twins.
  • More than 8 weeks and no more than 22 weeks and 6 days pregnant when joining, based on the study’s due date.
  • Age 18 or older.
  • Have type 1 or type 2 diabetes.
  • Answer “Often” or “Sometimes” to at least one of two food access screening questions within 12 months of starting prenatal care.
  • Speak English or Spanish.
  • Willing to join the Mid-Ohio Farmacy program and give a home address where the Mid-Ohio Food Collective can deliver food.
  • Have an A1c (a blood test showing average blood sugar) of at least 6.5%. If you have not taken GLP-1 or SGLT2 diabetes medicines within 12 months of starting prenatal care, the result must be from that time. If you have taken them during that time, the result must be from the 12 months before you started those medicines.

Who can't join

  • Held or confined against your will.
  • Judged to have a reduced ability to make decisions.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

OH