Statement Highlights:
- The American Heart Association defines ‘food is medicine’ as the provision of healthy foods prescribed within a health care setting to prevent, manage and treat diet-related chronic disease.
- A systematic review of randomized controlled trials on food is medicine (FIM) programs contributed to improvements in diet quality and food security among people with chronic diseases.
- However, substantial gaps in existing research call for larger, higher quality and longer-term studies, including randomized controlled trials to better understand the clinical outcomes for patients in FIM programs.
- Additional research studies, such as those funded by the American Heart Association’s Health Care by Food™ initiative, are needed to demonstrate the impact of food is medicine on clinical outcomes.
- The initiative is funding 23 pilot trials that are focusing on implementation science and behavioral economics to improve participation engagement that will inform subsequent, more definitive studies to achieve greater efficacy and cost effectiveness of those interventions.
DALLAS, June 18, 2025 — Food is medicine (FIM) programs that incorporate healthy food into health care for people with or at high risk for chronic disease show great potential in improving diet quality and food security, but additional research is needed to understand clinical outcomes, according to a systematic review of randomized controlled trials in the U.S conducted by the American Heart Association. The findings point to the need for efforts such as the Association’s Health Care by Food™ initiative to address critical gaps in the research to improve understanding of FIM’s impact on long-term clinical outcomes for patients.
The Association, a global force changing the future of health for all, published these findings and future directions today in a scientific statement, “A Systematic Review of ’Food Is Medicine’ Randomized Controlled Trials for Noncommunicable Disease in the United States,“ in the Association’s flagship journal Circulation.
The scientific statement underscores the growing potential of FIM programs based on a systematic review of 14 randomized controlled trials looking at the impact of FIM interventions, such as produce prescriptions, medically tailored groceries and medically tailored meals. The review found great potential for improvements among patients in diet quality and food security, both key metrics for improving health. But improvements in outcomes including hemoglobin A1c, blood pressure and body mass index were inconsistent. This may have been due to factors such as small sample size and short study duration. The findings point to the need for larger, better-designed studies.
“Scientific studies show that food is medicine programs incorporating healthy food into health care hold great promise to address the rising incidence and cost of cardiometabolic diseases and other chronic conditions caused by poor diet,” said Hilary K. Seligman, M.D., M.A.S., American Heart Association volunteer, chair of the scientific advisory writing group and professor of medicine at the University of California, San Francisco. “By addressing gaps in the research with more rigorous studies on food is medicine, we’ll determine how best to design and implement these programs to improve the health of people with chronic disease and those at high risk.”
Forty-seven million Americans face food insecurity, which significantly impacts diet quality and health outcomes.1,2 Meanwhile, treating diet-related cardiometabolic diseases costs the U.S. approximately $50.4 billion annually.3,4
The scientific statement calls for:
- More rigorous and longer-term randomized controlled trials to evaluate the impact of food is medicine on health outcomes.
- Standardization of the foods and interventions allowable in FIM programs.
- A stepwise research approach, starting with small-scale studies and expanding to real-world implementation.
“We need to treat programs that provide food to patients with diet-related chronic conditions who are struggling to improve their health like any other part of medical care by integrating it as a fundamental part of the health care system,” said Kevin Volpp, M.D., Ph.D., American Heart Association volunteer, scientific lead for the Health Care by Food initiative and founding director of the Center for Health Incentives and Behavioral Economics at the University of Pennsylvania’s Perelman School of Medicine and the Wharton School. “This statement is a call to action for researchers, clinicians and policymakers to invest in the science needed to make food is medicine a cornerstone of chronic disease prevention and treatment.”
The American Heart Association’s Health Care by Food initiative, launched in September 2023, aims to build a strong evidence base for integrating nutritious food into health care delivery. The initiative emphasizes the need for systematic approaches to bridge these gaps and scale effective interventions.
Health Care by Food is guided by a strategic research approach that began by funding 23 initial small-scale studies. Learnings from these will help to inform real-world trials to include implementation science and behavioral economics for improving engagement, translating evidence into practice and promoting broad implementation and insurance coverage.
“By defining the research needed to advance the food is medicine field, including optimal intervention design, populations most likely to benefit and long-term impacts, this scientific statement lays the foundation for developing evidence that can inform health care practices and policies aimed at improving health for everyone everywhere and reducing health care costs,” said Mitchell S.V. Elkind, M.D., M.S., a co-author of the scientific statement and chief clinical science officer of the Association.
Additional Resources:
###
About the American Heart Association
The American Heart Association is a relentless force for a world of longer, healthier lives. Dedicated to ensuring equitable health in all communities, the organization has been a leading source of health information for more than one hundred years. Supported by more than 35 million volunteers globally, we fund groundbreaking research, advocate for the public’s health, and provide critical resources to save and improve lives affected by cardiovascular disease and stroke. By driving breakthroughs and implementing proven solutions in science, policy, and care, we work tirelessly to advance health and transform lives every day. Connect with us on heart.org, Facebook, X or by calling 1-800-AHA-USA1.
heart.org and stroke.org
1Gundersen C, Ziliak JP. Food insecurity and health outcomes. Health Aff (Millwood). 2015;34:1830–1839.
2US Department of Agriculture, Economic Research Service. Frequency of food insecurity. 2023. Accessed August 20, 2024.
3Cardiometabolic disease costs associated with suboptimal diet in the United States: a cost analysis based on a microsimulation model. PLoS Med. 2019;16:e1002981
4Micha R, Peñalvo JL, Cudhea F, Imamura F, Rehm CD, Mozaffarian D. Association between dietary factors and mortality from heart disease, stroke, and type 2 diabetes in the United States. JAMA. 2017;317:912–924.