NOURISH - A Healthcare-community Partnership to Improve Nutrition for Optimal Glycemic Control an… (NCT07560813) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
NOURISH - A Healthcare-community Partnership to Improve Nutrition for Optimal Glycemic Control and Pregnancy Outcomes With Pregestational Diabetes
United States174 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for people with pre-existing Type 1 or Type 2 diabetes who are already pregnant — given my situation, is this something my care team thinks would be relevant to discuss, even though they're no longer actively enrolling new participants?
2The trial targets an A1c below 6.5% before delivery as its main goal — how does that compare to where my A1c is right now, and is that level of control realistic and safe to aim for in my case?
3Since this is a Phase NA study focused on a healthcare-community nutrition partnership, what kind of dietary support or community-based resources would actually be involved, and how demanding would that be to fit into my pregnancy schedule?
4Given that enrollment is closed, are there other nutrition-focused programs or studies for pregnant people with pregestational diabetes that my care team would recommend as an alternative?
5How does participating in a nutrition intervention study like this compare to the standard nutritional counseling I would receive as part of my regular high-risk pregnancy care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary clinical outcome is the proportion of participants with an A1c <6.5% before delivery.
Timeframe: Approximately once per trimester every 12-14 weeks betwee trial enrollment through 6-12 weeks postpartum.