Abstract
INTRODUCTION: Linking patients living with chronic, diet-related diseases and food insecurity to charitable food assistance, medically tailored groceries (MTGs) and food resource coaching may empower patients to better manage their health in a way that is economically sustainable. This protocol paper describes the implementation of a study evaluating MTGs and food resource coaching in a food pantry setting. METHODS AND ANALYSIS: A randomised controlled trial whereby patients of a safety-net health centre will be screened for The Emergency Food Assistance Program (TEFAP) and study eligibility. Eligible patients will be randomised to receive 4 months of usual pantry services (control), MTGs (intervention 1) or MTGs and food resource coaching (intervention 2) from a colocated food pantry. Measures collected monthly include adherence, fidelity and food selections from the pantry. Measures collected at baseline and follow-up include food and nutrition security, diet quality, household resiliency, loneliness and overall well-being. Qualitative interviews (n=60) will be conducted preintervention and postintervention. Analyses will include multiple regression models to analyse changes from baseline to follow-up as well as changes between groups over time. Deductive thematic analysis of qualitative data will be conducted. ETHICS AND DISSEMINATION: This study was approved by the UT Southwestern Medical Center Institutional Review Board (STU-2023-1166) and the Parkland Health Office of Research Administration. This is protocol version two, modification approved on 3 June 2024. Findings will be disseminated through academic conferences, journals and to the public. TRIAL REGISTRATION NUMBER: NCT06242808.