乌鸦传媒

An intensive food-as-medicine program didn't improve glycemic control in adults with type 2 diabetes any better than usual care in a randomized clinical trial.

After 6 months, both groups had a similar drop in HbA1c -- 1.5 percentage points among program enrollees and 1.3 percentage points with usual care (between-group adjusted mean -0.10, P=0.57), Joseph Doyle, PhD, of Massachusetts Institute of Technology in Cambridge, and colleagues reported.

There were no significant differences in other metabolic lab values between the groups either, the researchers wrote in . These included cholesterol, triglycerides, and fasting glucose levels. On top of that, the food-as-medicine participants even gained some weight compared with the usual care group over 6 months (adjusted mean difference 1.95 kg, P=0.04).

"I was surprised by the findings because the program is so intensive," Doyle told 乌鸦传媒. "The health system built brick-and-mortar clinics, staffed them with a dietitian, nurse, and community health worker, had weekly food pick-up for 10 meals per week for the entire family, and participants spend a year in the program."

"The program inspires its participants, and we found it increases their engagement with healthcare, which we expected going in," added Doyle. "I would have expected that this would have improved the primary measure of diabetes interventions, HbA1c, more compared to a group that did not have access to such a program."

He highlighted that while glycemic control wasn't significantly better compared with usual care, it was still reassuring that both groups had an HbA1c drop and that the program participants had better engagement with healthcare, "which is a priority for disadvantaged patients."

Costing an estimated $2,000 annually per participant, the food-as-medicine program allowed participants to choose from a variety of vegetables, fruits, and entrees each week -- enough food for two meals a day, 5 days a week. They were also provided recipes and cooking instructions and met with dietitians to track goals. On the other hand, the control group was only provided usual care, a list of local food bank locations, and the option to join the program after 6 months.

In an accompanying , journal deputy editor Deborah Grady, MD, MPH, addressed potential ethical concerns with the study design, writing: "Some might consider it unethical not to provide healthy food to patients with uncontrolled type 2 diabetes and food insecurity. However, we believe a control group is crucial in this type of unblinded trial. If this trial had been uncontrolled, the intervention would have been found effective.

"The design provided a randomized comparison group that did not get the food intervention at the same time as the intervention group but still provided 6 months of healthy food at the end of the waiting period," she wrote.

The trial was conducted at two sites, one rural and one urban, in the mid-Atlantic region. It recruited 465 adults with type 2 diabetes who completed the study, all of whom started with an HbA1c of 8% or higher. All participants were also self-reported as food insecure. The average age was 54.6 years, 54.8% of participants were female, 81.3% were white, and most resided in the urban location. Of note, all participants also resided in the program's service area and were affiliated with the health system that ran it.

"One study should not be over-interpreted," said Doyle. "It is possible that such a program could work in other contexts, among patients less connected to a health system, or in other formats. The main alternative to providing healthy groceries and education is to provide pre-made 'medically tailored meals.'"

"I hope the study raises awareness of the potential for food-as-medicine programs to increase healthcare engagement and to push researchers and policymakers to generate more evidence on ways such programs can improve health."

While the food-as-medicine program fell short at improving these parameters, program participants did reap a few other benefits. These included an improvement in diet from the year prior and a higher percentage of individuals with metformin and GLP-1 receptor agonist prescriptions.

"We know food insecurity is harmful for health and well-being," Doyle concluded. "If we want health systems to address it, we should continue to look for ways that such programs achieve health gains."

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