Speaker
Joseph Doyle, PhD
Erwin H. Schell Professor of Management and Applied Economics
MIT Sloan School of Management
Keywords
Food-as-Medicine, Randomized Clinical Trial, Diabetes
Key Points
- Diabetes is common and costly. 9% of the U.S. has the condition; it is responsible for 300,000 premature deaths/year and $330 billion in annual healthcare spending. Payers should have some incentive to improve outcomes because sustained reduction in HbA1c from poor to fair can result in cost savings. Food insecurity is associated with diabetes.
- Food-as-Medicine observational studies have had a large correlation with improved health.
- For the intervention in this Food-as-Medicine trial, participants with diabetes were prescribed 10 meals/week for participants and their families that they could fill at the program’s clinic. Clinic staff included a dietitian, a nurse and a community health worker. The dietician met with the patient to share education about nutrition, portion size, recipes to make food taste good, and information via an optional diabetes self-management program. They also screened for complications and close care gaps. The average duration of the intervention was 1 year, and the cost was about $2,000 per participant.
- The trial was for adults with HbA1c greater than 8.0, who were food insecure and lived within a residential zip code within 25 miles of a clinic. Recruitment was by phone calls and physician referrals, and consent was over the phone. Randomization was stratified by HbA1c greater than 9.5 and site. The intervention group started the program now. The control group started in 6 months and received a brochure that lists addresses of area food banks.
- The primary outcome was HbA1c after 6 months. Lab results for HbA1c, cholesterol, triglycerides, blood pressure, weight were taken at 0, 6 and 12 months. There were also surveys to assess program education, diet, a self-efficacy questionnaire, and a self-assessed physical and mental health questionnaire at 0, 6, and 12 months. Participants received a $50 gift card for completing the labs and surveys.
- Additional data sources came from EHR data, health plan claims, and program participation data including food visits and education.
- 500 patients were randomized to intervention or control groups, with a utilization of 465 and 349 participants completing the 6-month HbA1c lab sample. The treatment group started with a mean 10.3 HbA1c it dropped to a mean of 8.8 at 6 months, which plateaued in 12 months. The control group followed similarly. There were no significant drops in cholesterol, triglycerides, or fasting glucose and weight did not lower. There was not a statistically significant difference between the 2 groups at 12 months.
- The study found a null effect on HbA1c. The study did find substantial effects on diet and healthcare engagement.
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Discussion Themes
-Why do you think it was a negative study? The idea was that they would have to go get the food. Medically tailored meals is the alternative. We don’t have the diaries of what they do with the food. We see people visiting the fresh food pharmacies for up to 12 months. When they get home do they give the food away, eat it themselves, throw it away, we don’t know. In terms of the types of food they had, they were not especially culturally diverse.
–Can you say something about the dose of the meal, which was 10 meals a week? Were people eating less healthy meals for the non-program meals? How much food to give is a parameter that needs more research. The dietitians in the program thought that 10 meals a week was the right number and that providing all meals would have been too much and resulted in waste. From a researcher standpoint, we need more information.
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