Trial results for the Fresh Food Farmacy program, investigating its impact on Type 2 Diabetes, were posted on 2025-06-12. The program, which provides healthy food and education, showed no statistically significant effect on HbA1c or fasting glucose levels over 6 or 12 months.
Background
Type 2 Diabetes is a chronic metabolic condition characterized by high blood sugar levels. Management often involves lifestyle modifications, including diet and exercise, alongside medication. Programs addressing food insecurity and providing health education, such as the Fresh Food Farmacy, aim to support patients in managing their condition by improving access to healthy food and promoting self-management skills.
Trial design
This randomized controlled trial, designated as Phase NA, enrolled 500 participants with Type 2 Diabetes. The study investigated the Fresh Food Farmacy (FFF) program, which provided food-insecure diabetic participants and their households with healthy food (at least two meals per day, five days a week) along with education on food preparation and healthy living, including diabetes self-management. Participants were divided into a "Treatment Group-Begin Now" and a "Control Group-Begin Later" arm. The research measured effects on patient health and wellbeing, focusing on outcomes such as HbA1c, fasting glucose, and weight.
Key results
The study reported the following key measurements for both groups:
- HbA1c (% of hemoglobin):
- At an initial measurement, the Treatment Group-Begin Now had a mean HbA1c of 8.781177% (Standard Deviation 1.643995%), while the Control Group-Begin Later had a mean of 8.814526% (Standard Deviation 1.978937%).
- At a later measurement, the Treatment Group-Begin Now had a mean HbA1c of 8.735975% (Standard Deviation 1.748229%), and the Control Group-Begin Later had a mean of 8.595031% (Standard Deviation 2.035983%).
- Fasting Glucose (mg/dL):
- Initially, the Treatment Group-Begin Now showed a mean fasting glucose of 185.0236 mg/dL (Standard Deviation 76.36467 mg/dL), compared to 198.292 mg/dL (Standard Deviation 99.97935 mg/dL) in the Control Group-Begin Later.
- At a later measurement, the Treatment Group-Begin Now had a mean fasting glucose of 185.4696 mg/dL (Standard Deviation 68.86821 mg/dL), while the Control Group-Begin Later had a mean of 172.3441 mg/dL (Standard Deviation 68.18301 mg/dL).
- Weight (pounds (lb)):
- Initially, the Treatment Group-Begin Now had a mean weight of 230.8205 pounds (lb) (Standard Deviation 60.13527 pounds (lb)), compared to 238.9561 pounds (lb) (Standard Deviation 66.3286 pounds (lb)) in the Control Group-Begin Later.
- At a later measurement, the Treatment Group-Begin Now had a mean weight of 227.9171 pounds (lb) (Standard Deviation 58.1217 pounds (lb)), and the Control Group-Begin Later had a mean of 237.5989 pounds (lb) (Standard Deviation 63.47953 pounds (lb)).
Key analyses comparing the groups yielded the following results:
- For HbA1c at 6 months after trial enrollment, the unadjusted mean difference was -0.0333487 (95.0% CI [-0.415628, 0.3489306]) with a p-value of 0.8638688 (t-test, 2 sided). The adjusted mean difference was -0.0066385 (95.0% CI [-0.371329, 0.358052]) with a p-value of 0.9714571 (Linear Regression).
- For HbA1c at 12 months after trial enrollment, the unadjusted mean difference was 0.1409446 (95.0% CI [-0.2735162, 0.5554053]) with a p-value of 0.5039565 (t-test, 2 sided). The adjusted mean difference was 0.1213915 (95.0% CI [-0.2970052, 0.5397882]) with a p-value of 0.5684854 (Linear Regression).
- For Fasting Glucose at 6 months after trial enrollment, the unadjusted mean difference was -13.26835 (95.0% CI [-34.73804, 8.201347]) with a p-value of 0.2247426 (t-test, 2 sided). The adjusted mean difference was -12.20164 (95.0% CI [-34.37119, 9.9679]) with a p-value of 0.2794015 (Linear Regression).
What this means
The results of the Fresh Food Farmacy trial indicate that the program, as implemented, did not lead to a statistically significant improvement in key glycemic control markers, specifically HbA1c and fasting glucose levels, at either 6 or 12 months after enrollment. The reported p-values for all analyses were well above conventional thresholds for statistical significance, suggesting that the observed differences between the treatment and control groups could be due to chance. While providing healthy food and education is generally considered beneficial for managing Type 2 Diabetes, this specific trial's data does not demonstrate a measurable impact on these particular clinical endpoints within the study's timeframe and design.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03718832, titled "Fresh Food Farmacy: A Randomized Controlled Trial", were posted on 2025-06-12 on clinicaltrials.gov.