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
TL;DR
This two-arm randomised controlled trial will examine the combined effects of a tripartite NOURISH intervention versus the current standard of diabetes and prenatal care, and measure the primary outcome of glycaemic management by delivery and adverse pregnancy outcomes.
Abstract
Introduction Pregestational diabetes is one of the most frequent medical conditions in pregnancy. Nutrition insecurity is a non-medical, health-related social need and affects glycaemic management and pregnancy outcomes for women with both type 1 and type 2 pregestational diabetes. Collaborative healthcare-community partnerships to enhance food access, facilitate culinary medicine, diabetes self-management education and support (DSMES) and address unmet social needs for pregnant women with pregestational diabetes remain to be evaluated. Methods and analysis In a two-arm randomised controlled trial, we will examine the combined effects of a tripartite NOURISH intervention ((1) produce home delivery, (2) culinary medicine with DSMES and (3) community health worker-led social needs assessment and support) versus the current standard of diabetes and prenatal care. We will recruit and enrol 174 pregnant women (87 NOURISH, 87 standard care) ≤22+6 weeks of gestation with pregestational diabetes, inadequate glycaemic management (haemoglobin A1c≥6.5%) and self-reported risk of food insecurity from a diabetes and prenatal care programme at a tertiary care academic health system located in the USA. We will measure the primary outcome of glycaemic management by delivery (haemoglobin A1c<6.5%), and secondarily, adverse pregnancy outcomes (gestational weight gain and composite neonatal morbidity) and patient-reported outcomes (nutrition security). We will also use cost-effectiveness analysis to assess the intervention’s value relative to standard care and use process evaluation to characterise intervention and contextual factors influencing uptake, effectiveness and sustainability. Ethics and dissemination The Institutional Review Board at The Ohio State University approved this study (IRB: STUDY20260307; date: 23 April 2026). We plan to submit results of the trial for publication in peer-reviewed journals and presentations at international scientific meetings. Trial registration number NCT07560813.