Work

Protocol for the Nutrition OUtReach In Systems of Healthcare (NOURISH) trial: a phase II multicentre, parallel-group randomised controlled trial of medically tailored groceries to prevent malnutrition in transplant and cellular therapy patients

Year: 2026

Type: article

Abstract: Introduction Food insecurity (FI) is a health-related social risk associated with malnutrition, morbidity and increased health expenditures in patients undergoing cancer treatment. Among transplant and cellular therapy (TCT) patients, FI is exacerbated by the financial toxicity associated with treatment costs. The Nutrition OUtReach In Systems of Healthcare (NOURISH) trial is a multicentre randomised controlled trial designed to evaluate the impact of in-clinic delivery of medically tailored groceries (MTGs) on malnutrition risk, clinical outcomes and healthcare costs among food insecure TCT patients. Methods and analysis We will recruit 210 food-insecure patients from four sites across the USA to be randomised to receive an MTG bag (intervention) or information on food bank resources (control). We hypothesise that the intervention will decrease malnutrition risk (primary endpoint) by mitigating FI, improving clinical outcomes and reducing healthcare costs while patients are receiving TCT. We will assess malnutrition by using the Global Leader in Malnutrition criteria. A χ2 test will examine the null hypothesis that 100-day malnutrition rates in the intervention and control arms are equal, using a two-sided 0.05 significance level. Trajectories over time of calorie intake and protein intake will be compared using mixed linear models. Ethics and dissemination This study used human participants and was approved through the University of Kansas Medical Center Institutional Review Board (STUDY00161189). All participants provided written informed consent prior to participation in the study. We plan to disseminate results to study participants, participating institutions, peer-reviewed medical journals and national organisations. Trial registration number NCT06802406.

Source: BMJ Open

DOI: 10.1136/bmjopen-2026-123025