A pilot randomized controlled trial of medically tailored groceries and resource coaching: secondary and exploratory diet and health outcomes

Patient access to nutritious food is critical for managing cardiometabolic conditions, yet barriers persist in under-resourced populations. This pilot randomized controlled trial (N = 210) evaluated the impact of medically tailored groceries (MTG) and food resource coaching (Coach) delivered via a co-located food pantry. Participants with Type 2 diabetes, dyslipidemias, and/or hypertension were recruited from a safety-net health center and received either usual pantry support, MTG, or MTG+Coach for four months. Exploratory outcomes reported herein include self-reported diet quality, food security, and perceived health; blood pressure (BP) from electronic health records (N = 166). Additional exploratory self-reported outcomes recommended by the funder and detailed in the supplemental materials include nutrition security, wellbeing (EQ-5D-51), loneliness, adaptive capacity, and the Cooking and Food Provisioning Action Scale. Follow-up completion was 81%. All groups improved over time in food security, diet quality, and perceived health (P < 0.001), but baseline-adjusted analyses did not identify clear differences between MTG arms and usual pantry support for any exploratory outcome. Although descriptively larger BP reductions were observed in the intervention groups, confidence intervals were wide and adjusted between-group comparisons were not statistically significant. Further studies with standardized clinical measurement are warranted. Trial registration: This trial and protocol were submitted to ClinicalTrials.gov (Identifier: NCT06242808) on February 3rd, 2024, prior to recruitment. Here, the authors report secondary and exploratory outcomes of a pilot randomized controlled trial exploring a food-is-medicine intervention of medically tailored groceries with or without resource coaching against usual pantry support. All groups improved over time in food security, diet quality, and perceived health, but baseline-adjusted analyses did not identify clear differences between the groups.