How well can a healthy diet improve diabetes? A new medical program that seeks to treat diabetes by improving nutrition has very modest effects, according to the first fully randomized clinical trial of human subjects. It has been shown that
The study, co-authored by Joseph Doyle, a healthcare economist at the Massachusetts Institute of Technology Sloan School of Management, followed participants in an innovative program that provided healthy diets to simultaneously address diabetes and food insecurity. ing. The experiment focused on his type 2 diabetes, the most common form.
The program involved people with high blood sugar levels, in this case HbA1c hemoglobin levels of 8.0 or higher. Participants in a clinical trial who were given food to make 10 nutritious meals a week saw their hemoglobin A1c levels drop by 1.5 percentage points over six months. However, trial participants who were deprived of food had a 1.3 percentage point drop in their HbA1c levels over the same period. This suggests that the relative effectiveness of programs is limited and that health care providers need to continue refining such interventions.
“When people have access to [got food from] “When they did the program, their blood sugar levels did drop, but the control group’s blood sugar levels dropped by about the same amount,” said Doyle, the Irwin H. Shell Professor of Management at MIT Sloan.
Given that this type of effort is rarely studied through clinical trials, Doyle doesn’t want one study to be the end of the story and hopes more research will be spurred to find ways to make a big impact. He added that he hopes for Additionally, by addressing food insecurity, such programs help people who don’t have access to healthy food in the first place.
“We know that food insecurity is a problem for people, so there are benefits in and of itself to address it, but when we address it through the health care system, we need to find the best way to improve health at the same time.” Doyle added.
The paper “Effects of an Intensive Food-as-Drugs Program on Health and Healthcare Use: A Randomized Clinical Trial” is published today. JAMA Internal Medicine.
The author is Doyle. Marcela Alsan, Professor of Public Policy at Harvard Kennedy School. Nicholas Skelly, MIT Sloan Health System Initiative Postdoctoral Fellow. Yutong Lu, Predoctoral Technology Associate, MIT Sloan Health Systems Initiative; John Cawley, professor in Cornell University’s Department of Economics and School of Policy Analysis and Management and co-director of the Cornell Institute for Health Economics, Health Behavior, and Disparities.
To conduct this study, researchers partnered with a major health care provider in the Mid-Atlantic region of the United States that is developing a food-as-medicine program. Such programs are becoming increasingly popular in the medical field and could be used to treat diabetes, a disease that causes elevated blood sugar levels and can lead to serious or even fatal complications. Diabetes affects approximately 10% of the adult population.
The study consisted of a randomized clinical trial of 465 adults with type 2 diabetes at two sites within a network of healthcare providers. One location was part of an urban area and the other was rural. The study ran from 2019 to 2022, followed by a one-year follow-up. Those in the study’s treatment group received 10 healthy meals a week for their families over a six-month period and were also given the opportunity to consult with a nutritionist and nurse. Participants in both treatment and control groups underwent regular blood tests.
Compliance with the program was very high. But in the end, people in the treatment group experienced only a slightly greater drop in blood sugar levels than people in the control group.
Given these results, Doyle and his co-authors seek to explain why the food intervention did not have a relatively large impact. First, he points out that some fundamental reversion to the mean may be underway. Some people in the control group with high blood sugar levels were likely to improve their blood sugar levels even without participating in the program.
“When we test people whose health is deteriorating, many improve on their own if they take steps to move out of this danger zone, such as making modest changes in diet and exercise,” Doyle says.
Furthermore, because the healthy eating program was developed by health care providers who remain engaged with all participants, those in the control group still benefit from health care engagement, and those in the control group without such health care access They may have done better than the herd.
Similar results were also obtained when looking at results before the pandemic, but it is possible that the COVID-19 pandemic that occurred during the experiment period may have influenced the results in some way. Alternatively, the effects of the intervention may be felt over a longer period of time.
Additionally, although meals were provided in this program, meal preparation was left to participants, which may have been a hurdle to program compliance. Potentially, pre-prepared meals can have a bigger impact.
“It seems like a natural next step to experiment with providing these ready-made meals,” Doyle said, especially as such programs evolve. , emphasize that further research is required if several different formats are to be tried. And features.
“If we find that a particular intervention doesn’t improve blood sugar levels, we don’t just say you shouldn’t do that intervention at all,” Doyle says. “Our research definitely raises questions and provides new answers never seen before.”
Research support was provided by the Robert Wood Johnson Foundation. Abdul Latif Jameel Poverty Action Lab (J-PAL). and the MIT Sloan Health System Initiative. In addition to his submitted work, Corey reports that he receives personal fees from Nordisk, a pharmaceutical company that makes diabetes and other treatments.