Healthcare-community partnership to improve nutrition insecurity for optimal glycaemic control and pregnancy outcomes in women with pregestational diabetes: clinical trial protocol for the NOURISH study

Top Things to Know

This study represents a comprehensive FIM model that combines a produce prescription (weekly home-delivered produce), nutrition and culinary education, and community health worker support to address both nutrition insecurity and related social needs.

The trial focuses on a high-risk population of pregnant people with diabetes and food insecurity, an area where robust randomized evidence for FIM interventions is currently lacking.

If effective, the intervention could provide evidence for integrating healthcare systems, food banks, and community-based organizations to improve diabetes and pregnancy outcomes.

Summary of Conclusion/Findings

This article describes the protocol for the NOURISH randomized controlled trial, which will evaluate whether a healthcare-community partnership can improve glycemic control, nutrition security, and pregnancy outcomes among pregnant women with pregestational type 1 or type 2 diabetes who have inadequate glycemic management and are at risk for food insecurity. The study plans to enroll 174 participants (87 intervention, 87 standard care) by 22 weeks and 6 days of gestation and compare a three-component intervention consisting of home-delivered produce, culinary medicine with diabetes self-management education and support (DSMES), and community health worker-led social needs assessment and referrals against standard prenatal and diabetes care. The primary outcome is achieving hemoglobin A1c <6.5% by delivery, with secondary outcomes including gestational weight gain, composite neonatal morbidity, nutrition security, and other clinical and patient-reported measures. Investigators hypothesize that participants receiving the intervention will be 1.8 times more likely to achieve the target A1c level by delivery than those receiving standard care. In addition to clinical effectiveness, the trial will assess cost-effectiveness and conduct a mixed-methods process evaluation to examine implementation, uptake, fidelity, sustainability, and scalability.