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.

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.