The study, reported in JAMA Internal Medicine, looked at a program designed for patients with Type II diabetes and hemoglobinA1c (HbA1c) levels of 8.0% or higher who self-reported “food insecurity.” HBA1c is a measure of long-term glucose control, blood sugar is a measure of acute control. They received consultations with dieticians, preventative care from nurses, and enough “healthy ingredients for ten meals each week for the entire household.” Individuals on the waiting list for the program served as controls. HbA1c at six and twelve months was the primary outcome measure. [1]
There were 349 participants, mean age of 55.3, slightly more female (53.6%), and roughly 9% Hispanic, 7% Black, and 82% White. Baseline HbA1c level of 10.29% indicates poor blood sugar control/management.
Results
The intervention group had significantly more visits to the program clinic, 13 over six months, than the control group, 0.72 visits. This is unsurprising given that the intervention group received their ten meals worth of nutritious foods at each visit while the control group might, at best, receive some advice. This “engagement” with the program remained at 12 months.
Simply participating in the study resulted in the participants feeling that their diet had improved, more so for the intervention group, 93.3%, than the control, 77.2%. This resulted in a 38% improvement in their diet [2]. Specifically, the treatment group ate more dark green vegetables, fewer fast foods and sweetened beverages. None of these interventions were statistically significant.
HbA1c levels fell by 1.3 percentage points for the control group and 1.5 percentage points for the treatment group. These values were not statistically or clinically significant.
There was no detectable impact on other laboratory results, including cholesterol, triglycerides, and fasting glucose levels, at either 6 months or 12 months. Nor was there a significant weight loss or improvement in hypertension.
There was no detectable change in attitudes toward their health, diabetes self-management, exercise, or smoking between the treatment and control groups.
At an average annual cost per participant of $2,000, we got bupkis, no improvement in clinical markers, but a sense that participation had improved their diet. This study affirmed the “Hawthorne Effect” - the alteration of human behavior when individuals are aware that they are being observed, studied, or included in an experiment. And the Hawthorne’s effect’s lack of power to effect meaningful change
“In this randomized clinical trial, an intensive food-as-medicine program increased engagement with preventive health care but did not improve glycemic control compared with usual care among adult participants.”
Simply providing nutritious groceries does not guarantee an improvement in our health. In addition to many other external factors, one has to take these whole foods and create meals, a vanishing skill in our culture because we do not teach it as a part of public education, and convenience is often more important than nutrition. Access to care, as was available to both the treatment and control groups, is a necessary but not sufficient component to improving one’s health. Until that additional portion of the “secret sauce” is identified and fostered, food-as-medicine remains an academic aspiration without real-world benefits.
[1] Since the study period ran through the pandemic, weekly food pickup was changed to every other week in March 2020. Dietitian and care team consultations were conducted by telemedicine.
[2] The actual calculation of diet improvement is not given in the body or supplement to the study.
Source: Effect of an Intensive Food-as-Medicine Program on Health and Health Care Use A Randomized Clinical Trial JAMA Internal Medicine DOI: 10.1001/jamainternmed.2023.6670