Chronic disease is a national crisis and it disproportionately affects low income communities. Led by UC Irvine, this is the largest randomized Food is Medicine trial for Medicaid recipients with chronic conditions. It is designed to generate the first, nationally generalizable evidence on how strategic food assistance can fundamentally shift healthcare from a reactive model to one focused on prevention. By centering on Medicaid recipients in Southern California, we are building a model that is both deeply grounded in community needs and ready for widespread adoption across the United States.

Traditional food assistance programs often face limitations due to food deserts, high costs, and consumption cycles that leave families with no money for perishable food by the month's end. Our project leverages novel last-mile delivery technology to directly address these fundamental problems. We remove environmental barriers to healthy food access, increase affordability through efficient farm-to-consumer models, and improve consumption cycles through frequent, regular deliveries. This approach ensures fresh, medically tailored food reaches the doorsteps of vulnerable populations, enhancing their nutritional intake.

Our randomized controlled trial rigorously tests three Food is Medicine (FIM) interventions delivered weekly over nine months:

FoodBox: Weekly delivery of 15–20 lbs of medically tailored food: fresh produce, grains, legumes, and nuts (~$60 value).
FoodBox+: FoodBox plus culturally tailored nutrition education.
FreshFunds: $60/weekly online voucher for healthy food redeemable via Instacart.

These strategies are increasingly common in Medicaid and SNAP pilots, but lack comparative evidence. By recruiting a racially, linguistically, and geographically representative Medicaid sample and including a no-intervention control group, our design generates causal, generalizable insights into what works best—and why—to inform healthcare, food policy, and delivery innovation at scale.

Food is Medicine programs often struggle to scale due to high logistical costs, limited delivery capacity, and siloed implementation. Our approach solves for these barriers by partnering with established agricultural and logistics organizations that already serve high-need populations. We leverage proven last-mile infrastructure, smart routing, and existing distribution relationships to create a cost-effective, modular delivery model. It’s designed to be adopted by Medicaid Managed Care Plans, expanded across counties, and sustained well beyond the duration of the trial. By demonstrating feasibility at scale, we aim to redefine how healthy food becomes part of standard preventive care.

Every aspect of this study is built in collaboration with patients and community organizations to meaningfully address the real barriers, needs, and lived challenges of the populations we serve. Authentic community engagement is the foundation of our approach. From the outset, the study has been shaped by trusted frontline partners and local leaders. We now build on this groundwork with a formal engagement plan that includes a Patient Advisory Board (PAB) co-led by community and academic engagement experts. Through trusted, culturally rooted channels, we will conduct targeted interviews and continuous feedback loops to ensure our study questions, interventions, and outcomes are not only patient-centered—but community defined. This project is not just designed for the community it is built with them, at every step.

Our combined interview and blood sampling approach traces how food access improves health, financial stability, and patient empowerment.

This trial goes beyond clinical outcomes to evaluate how strategic food interventions shape the full spectrum of patient experience. By measuring both biological markers and lived realities through in-home interviews and Tasso-enabled blood sampling, we can uncover the direct and indirect ways food access affects health, income, and autonomy. This systems-level lens is essential for designing Food is Medicine solutions that work — not just in theory, but in practice, across institutions and lives.

This project is powered by a rare, multidisciplinary collaboration designed to deliver the most rigorous and policy-relevant Food as Medicine trial to date. Our team brings together leading academic researchers in health economics and clinical science, a trusted agricultural partner (Project FoodBox) with deep logistics expertise, and government leaders from the Orange County Social Services Agency and California Department of Health Care Services. The University of Michigan’s Survey Research Operations ensures gold-standard data collection and high response rates, while we deploy cutting-edge blood sampling technology (Tasso) to capture biological outcomes. To ensure the work is not only rigorous but also actionable and scalable, we are supported by an expanding advisory ecosystem that includes national policy leaders such as HealthBegins—bringing deep expertise in Medicaid transformation, food security integration, and social needs investment strategy. By integrating expertise across patient partners, food systems, healthcare delivery, population science, and policy, we are not just evaluating Food as Medicine — we are building the blueprint for its future at scale.

We share a commitment to reducing chronic disease and food insecurity in our communities. This trial identifies real-world interventions that can improve health and well-being at scale — and we can’t do it without trusted local partners.

We believe the best solutions are shaped by those who live the problem. That’s why we collaborate with local leaders, frontline organizations, and patients from the start. Community partners co-design recruitment, messaging, and delivery strategies — ensuring everything we do is culturally relevant and grounded in lived experience.

Our healthy food delivery model, led by Project Food Box, consistently receives high praise from participants. We’ve already seen strong adherence and enthusiasm, with qualitative and quantitative feedback demonstrating that people love it — and stick with it.

Your knowledge of local food systems, neighborhood dynamics, and trusted outreach channels is invaluable. By working together, we’re making Food is Medicine more effective, equitable, and enduring.

Our study is designed to meet the moment for Medicaid transformation. It draws on best-in-class tools, including financial modeling for social needs investments (e.g., HealthBegins’ Blended Value Course) and the Social Needs Investment Lab’s Evidence Assessment Library, to inform how Medicaid Managed Care Plans (MCPs) and other healthcare institutions allocate resources. We produce causal, comparative evidence on which Food is Medicine strategies work best — and why.

This trial directly supports Medicaid 1115 Waivers and U.S. HHS objectives for integrating nutrition into healthcare. It complements and builds upon existing national and state efforts, including the Medicaid Food Security Network, the Kaiser Permanente–supported initiative to scale Food is Medicine programs across California community health centers, and the Los Angeles Food Equity project. In collaboration with our policy and implementation partners, we will translate results into clear, scalable policy pathways.

Our interventions include direct home delivery of whole foods via Project FoodBox and grocery purchasing through Instacart — models already used in Medicaid pilots and SNAP. Logistics are scalable and patient centered by design, ensuring results are immediately applicable across systems and geographies.

The study focuses on Medicaid recipients, particularly those historically underrepresented in clinical trials. By centering underserved populations, we aim to generate high-quality, disaggregated evidence that addresses systemic disparities and drives health equity forward.

This trial stands as a national leader, setting a new standard for Food is Medicine research by uniquely bridging groundbreaking science with a commitment to real-world impact. Our project is enabled by a multidisciplinary collaboration that pushes the frontier of Food as Medicine.

Our team brings together a unique and powerful blend of expertise and infrastructure. It includes world-class academics who provide a rigorous experimental design, along with an agricultural partner (Project Food Box), government partners (OC SSA), and a top-tier research firm (University of Michigan’s SRO). We leverage frontier blood sampling technology to conduct interviews and ensure high response rates, addressing Food is Medicine from food systems to healthcare for a robust evaluation of our interventions.

This nine-month study uses a multi-arm RCT with a racially, geographically, and linguistically representative Medicaid sample. We compare three interventions:

• FoodBox: Weekly delivery of 15–20 lbs of medically tailored food: fresh produce, grains, legumes, and nuts (~$60 value).
• FoodBox+: FoodBox plus culturally tailored nutrition education.
• FreshFunds: $60/weekly online voucher for healthy food redeemable via Instacart.

A no-intervention control group enables causal attribution of outcomes related to health, behavior, and spending.

We utilize an innovative data collection approach combining one-hour in-person interviews at participants' homes with convenient at-home blood self-sampling kits (TassoInc). This strategy is explicitly designed to significantly reduce patient burden, maximize response rates, and ensure a truly representative sample, aligning with PCORI's emphasis on patient-centered research while enhancing data quality and inclusivity.

Beyond assessing direct outcomes, we meticulously investigate socio-economic mechanisms (e.g., financial constraints, access, nutritional awareness) that influence intervention impact. This approach provides a holistic understanding of how and why interventions are effective, crucial for shaping evidence-based policies.

Our study incorporates a critical feasibility phase designed to empirically validate and refine all operational, technical, and logistical aspects of the trial. This includes rigorously testing our innovative data collection methods, such as fully remote data collection and at-home blood sampling. This will contribute to developing robust, inexpensive, and customizable dietary intake data-capture tools and standardizing nutrition research methods for the broader FIM field.

We focus on patient-centered outcomes that matter most to patients, communities, and decision-makers. These include clinical biomarkers (e.g., HbA1c, cholesterol), dietary behaviors (fruit and vegetable intake, food insecurity, diet quality), mental and physical well-being (HRQoL, mental health, self-rated health), and healthcare utilization. All outcomes are assessed three times—at baseline, mid-study (18 weeks), and study end (36 weeks). We also track participant burden, adherence, and practical barriers to implementation.

We welcome collaboration from experts in economics, public health, nutrition, epidemiology, and implementation science. Our methods and tools are available for academic partners, and we aim to publish and share openly. Join us in building the future evidence base for Food is Medicine.

Your investment directly impacts patient health and informs future national healthcare policy.