Trial Outcomes & Findings for Fresh Food Farmacy: A Randomized Controlled Trial (NCT NCT03718832)

NCT ID: NCT03718832

Last Updated: 2025-06-12

Results Overview

Glycated hemoglobin (HbA1c) is a measure of the average share of glucose that has been in the bloodstream over the 2-3 months preceding measurement. HbA1c is measured by performing assays on samples of the participants' blood. Units are percentages; for differences between HbA1c values, units are percentage points. An HbA1c value of 6.5% is the lower threshold for type 2 diabetes. HbA1c values are rarely above 15-20%. In the context of this study (patients with type 2 diabetes), higher scores are considered a worse outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 500 participants
• Primary outcome timeframe: 6 months after trial enrollment
• Results posted on: 2025-06-12

Participant Flow

Participant milestones

Measure	Treatment Group-Begin Now Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.	Control Group-Begin Later Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).
Analysis Sample STARTED	249	251
Analysis Sample COMPLETED	230	235
Analysis Sample NOT COMPLETED	19	16
6-month HbA1c Sample STARTED	230	235
6-month HbA1c Sample COMPLETED	170	179
6-month HbA1c Sample NOT COMPLETED	60	56

Reasons for withdrawal

Measure	Treatment Group-Begin Now Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.	Control Group-Begin Later Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).
Analysis Sample Withdrawal by Subject	18	15
Analysis Sample Legal hold on data	1	0
Analysis Sample Participant from treated household	0	1
6-month HbA1c Sample Lost to Follow-up	60	56

Baseline Characteristics

Fresh Food Farmacy: A Randomized Controlled Trial

Baseline characteristics by cohort

Measure	Treatment Group-Begin Now n=230 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.	Control Group-Begin Later n=235 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Total n=465 Participants Total of all reporting groups
Age, Continuous	54.8 years STANDARD_DEVIATION 11.3 • n=5 Participants	54.4 years STANDARD_DEVIATION 12.4 • n=7 Participants	54.6 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	130 Participants n=5 Participants	125 Participants n=7 Participants	255 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	110 Participants n=7 Participants	210 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic (any race)	16 Participants n=5 Participants	23 Participants n=7 Participants	39 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	23 Participants n=5 Participants	18 Participants n=7 Participants	41 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	189 Participants n=5 Participants	189 Participants n=7 Participants	378 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic and other race	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	230 Participants n=5 Participants	235 Participants n=7 Participants	465 Participants n=5 Participants
Prior-year healthcare use Any inpatient admission	59 Participants n=5 Participants	48 Participants n=7 Participants	107 Participants n=5 Participants
Prior-year healthcare use Any emergency department visit	97 Participants n=5 Participants	94 Participants n=7 Participants	191 Participants n=5 Participants
Clinic location Rural	64 Participants n=5 Participants	67 Participants n=7 Participants	131 Participants n=5 Participants
Clinic location Urban	166 Participants n=5 Participants	168 Participants n=7 Participants	334 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after trial enrollment

Population: Participants from the 465-person analysis sample who completed an HbA1c blood test between 5 and 10 months after program enrollment.

Glycated hemoglobin (HbA1c) is a measure of the average share of glucose that has been in the bloodstream over the 2-3 months preceding measurement. HbA1c is measured by performing assays on samples of the participants' blood.

Units are percentages; for differences between HbA1c values, units are percentage points.

An HbA1c value of 6.5% is the lower threshold for type 2 diabetes. HbA1c values are rarely above 15-20%. In the context of this study (patients with type 2 diabetes), higher scores are considered a worse outcome.

Outcome measures

Measure	Control Group-Begin Later n=179 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=170 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
HbA1c	8.814526 % of hemoglobin Standard Deviation 1.978937	8.781177 % of hemoglobin Standard Deviation 1.643995

SECONDARY outcome

Timeframe: 12 months after trial enrollment

Glycated hemoglobin. Units are percentages (for differences, percentage points) reflecting the average share of glucose in the bloodstream over the previous 2-3 months.

An HbA1c value of 6.5% is the lower threshold for type 2 diabetes. HbA1c values are rarely above 15-20%.

In the context of this study (patients with type 2 diabetes), higher scores are considered a worse outcome.

Outcome measures

Measure	Control Group-Begin Later n=161 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=164 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
HbA1c	8.595031 % of hemoglobin Standard Deviation 2.035983	8.735975 % of hemoglobin Standard Deviation 1.748229

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in the number of participants who completed blood tests between 6 and 12 months after trial enrollment.

Fasting blood glucose is a measure of blood sugar control over a short time period (the blood glucose content after an overnight fast).

Units are mg/dL. To convert to mmol/L (SI), multiply by 0.0113. Lower fasting blood glucose levels indicate better health within the context of this study.

Outcome measures

Measure	Control Group-Begin Later n=137 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=127 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Fasting Glucose 6 months after trial enrollment	198.292 mg/dL Standard Deviation 99.97935	185.0236 mg/dL Standard Deviation 76.36467
Fasting Glucose 12 months after trial enrollment	172.3441 mg/dL Standard Deviation 68.18301	185.4696 mg/dL Standard Deviation 68.86821

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in the number of participants who had their weight recorded between 6 and 12 months after trial enrollment.

Weight in pounds. In the context of this study, higher values are considered a worse outcome.

SI conversion factor: To convert pounds to kilograms, multiply by 0.4536.

Outcome measures

Measure	Control Group-Begin Later n=205 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=195 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Weight (lb) 6 months after trial enrollment	238.9561 pounds (lb) Standard Deviation 66.3286	230.8205 pounds (lb) Standard Deviation 60.13527
Weight (lb) 12 months after trial enrollment	237.5989 pounds (lb) Standard Deviation 63.47953	227.9171 pounds (lb) Standard Deviation 58.1217

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in the number of participants whose weight was recorded between 6 and 12 months after trial enrollment.

Body Mass Index (BMI) in kg/m^2. BMI is computed using weight (lb) and height (in). The CDC's healthy reference range for BMI among adults aged 20 and older is 18.5 to 24.9. BMI values greater than or equal to 30.0 indicate obesity. In the context of this study, higher BMI is considered a worse outcome.

Outcome measures

Measure	Control Group-Begin Later n=205 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=195 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Body Mass Index 6 months after trial enrollment	37.6461 kg/m^2 Standard Deviation 10.06821	36.77117 kg/m^2 Standard Deviation 8.615884
Body Mass Index 12 months after trial enrollment	37.65195 kg/m^2 Standard Deviation 9.895644	36.20175 kg/m^2 Standard Deviation 8.299285

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in the number of participants who completed blood tests including cholesterol measurements between 6 and 12 months after trial enrollment.

Total cholesterol in mg/dL. The CDC recommends total cholesterol levels around 150 mg/dL and classifies levels of 200 mg/dL and above as unhealthy (hyperlipidemia). In the context of this study, higher total cholesterol indicates a worse outcome.

SI conversion factor: To convert from mg/dL to mmol/L, multiply by 0.0259.

Outcome measures

Measure	Control Group-Begin Later n=161 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=149 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Total Cholesterol 6 months after trial enrollment	160.5404 mg/dL Standard Deviation 48.39021	170.3087 mg/dL Standard Deviation 55.49542
Total Cholesterol 12 months after trial enrollment	165.3806 mg/dL Standard Deviation 56.96481	164.8345 mg/dL Standard Deviation 50.04346

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in the number of participants who completed blood tests including cholesterol measurements between 6 and 12 months after trial enrollment.

Low-density lipoprotein (LDL) cholesterol, measured in mg/dL. The CDC recommends LDL levels of 100 mg/dL or below. In the context of this study, higher levels of LDL indicate a worse outcome.

SI conversion factor: To convert from mg/dL to mmol/L, multiply by 0.0259.

Outcome measures

Measure	Control Group-Begin Later n=158 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=151 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
LDL Cholesterol 6 months after trial enrollment	85.19621 mg/dL Standard Deviation 36.72769	93.54835 mg/dL Standard Deviation 44.67019
LDL Cholesterol 12 months after trial enrollment	84.72519 mg/dL Standard Deviation 36.62367	87.36268 mg/dL Standard Deviation 36.73616

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in the number of participants who completed blood tests including cholesterol measurements between 6 and 12 months after trial enrollment.

High-density lipoprotein (HDL) cholesterol, measured in mg/dL. The CDC recommends HDL levels of at least 40 mg/dL in men and 50 mg/dL in women. In the context of this study, higher levels of HDL indicate a better outcome.

SI conversion factor: To convert mg/dL to mmol/L, multiply by 0.0259.

Outcome measures

Measure	Control Group-Begin Later n=161 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=149 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
HDL Cholesterol 6 months after trial enrollment	41.8323 mg/dL Standard Deviation 12.08006	41.27718 mg/dL Standard Deviation 12.98269
HDL Cholesterol 12 months after trial enrollment	43.73333 mg/dL Standard Deviation 17.07761	42.34722 mg/dL Standard Deviation 12.73743

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in the number of participants who completed blood tests including cholesterol measurements between 6 and 12 months after trial enrollment.

Triglycerides, measured in mg/dL. The CDC recommends levels of triglycerides below 150 mg/dL. In the context of this study, higher levels of triglycerides indicate worse outcomes.

SI conversion factor: To convert mg/dL to mmol/L, multiply by 0.0113.

Outcome measures

Measure	Control Group-Begin Later n=162 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=149 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Triglycerides 6 months after trial enrollment	201.0123 mg/dL Standard Deviation 157.1144	223.5705 mg/dL Standard Deviation 155.5674
Triglycerides 12 months after trial enrollment	224.1288 mg/dL Standard Deviation 268.9378	212.7762 mg/dL Standard Deviation 153.4214

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in the number of participants who had their blood pressure recorded between 6 and 12 months after trial enrollment.

Systolic blood pressure, measured in mm Hg. The CDC identifies normal healthy systolic blood pressure as below 120 mm Hg. The American College of Cardiology identifies 120 to 129 mm Hg as elevated blood pressure and 130 mm Hg and higher as hypertensive. Higher systolic blood pressure levels indicate worse outcomes.

Outcome measures

Measure	Control Group-Begin Later n=192 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=186 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Systolic Blood Pressure 6 months after trial enrollment	130.1823 mm Hg Standard Deviation 20.29064	128.3118 mm Hg Standard Deviation 19.06545
Systolic Blood Pressure 12 months after trial enrollment	129.7956 mm Hg Standard Deviation 18.45165	126.0235 mm Hg Standard Deviation 17.24071

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in the number of participants who had their blood pressure recorded between 6 and 12 months after trial enrollment.

Diastolic blood pressure, measured in mm Hg. The American College of Cardiology identifies normal diastolic blood pressure as below 80 mm Hg and elevated/hypertensive diastolic blood pressure as 80 mm Hg or above. Higher levels of diastolic blood pressure indicate worse outcomes.

Outcome measures

Measure	Control Group-Begin Later n=192 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=186 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Diastolic Blood Pressure 6 months after trial enrollment	74.76041 mm Hg Standard Deviation 10.40413	74.2043 mm Hg Standard Deviation 10.71504
Diastolic Blood Pressure 12 months after trial enrollment	73.98343 mm Hg Standard Deviation 10.46395	74.48235 mm Hg Standard Deviation 9.271847

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.

Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate fruit.

Outcome measures

Measure	Control Group-Begin Later n=170 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=163 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Times Eating Fruit in the Past 7 Days 6 months after trial enrollment	5.241177 # times Standard Deviation 3.397799	5.564417 # times Standard Deviation 3.344494
Times Eating Fruit in the Past 7 Days 12 months after trial enrollment	5.79562 # times Standard Deviation 3.343428	5.097222 # times Standard Deviation 2.377986

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.

Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate dark green vegetables.

Outcome measures

Measure	Control Group-Begin Later n=170 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=163 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Times Eating Dark Green Vegetables in the Past 7 Days 6 months after trial enrollment	4.011765 # times Standard Deviation 2.9007	6.288343 # times Standard Deviation 20.69643
Times Eating Dark Green Vegetables in the Past 7 Days 12 months after trial enrollment	5.782609 # times Standard Deviation 8.36899	4.202797 # times Standard Deviation 2.378186

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.

Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient drank sweetened beverages.

Outcome measures

Measure	Control Group-Begin Later n=167 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=162 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Times Drinking Sweetened Beverages in the Past 7 Days 6 months after trial enrollment	3.407186 # times Standard Deviation 4.495186	2.777778 # times Standard Deviation 3.449728
Times Drinking Sweetened Beverages in the Past 7 Days 12 months after trial enrollment	2.550725 # times Standard Deviation 3.60266	2.377622 # times Standard Deviation 3.116978

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.

Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate fast food, takeout, or at a restaurant.

Outcome measures

Measure	Control Group-Begin Later n=171 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=164 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Times Eating Out in the Past 7 Days 6 months after trial enrollment	4.017544 # times Standard Deviation 3.78771	4.5 # times Standard Deviation 3.948285
Times Eating Out in the Past 7 Days 12 months after trial enrollment	4.413043 # times Standard Deviation 3.927682	4.402778 # times Standard Deviation 3.956617

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.

Patient-reported measure of diet improvement: Survey question: "Do you believe your diet has improved compared to one year ago?".

Outcome measures

Measure	Control Group-Begin Later n=171 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=164 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Participants Answering "Yes" for Diet Improvement Compared to One Year Ago 6 months after trial enrollment	132 Participants	153 Participants
Participants Answering "Yes" for Diet Improvement Compared to One Year Ago 12 months after trial enrollment	129 Participants	137 Participants

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.

The proportion of questions testing patients' knowledge of how different factors contribute to blood sugar answered correctly.

Outcome measures

Measure	Control Group-Begin Later n=170 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=160 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Mean Proportion of Diabetes Knowledge Questions Answered Correctly 6 months after trial enrollment	0.7756302 proportion of questions Standard Deviation 0.1472909	0.8267857 proportion of questions Standard Deviation 0.1489169
Mean Proportion of Diabetes Knowledge Questions Answered Correctly 12 months after trial enrollment	0.8133472 proportion of questions Standard Deviation 0.1444886	0.8271728 proportion of questions Standard Deviation 0.1416987

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.

Survey-based index score for patient-reported positive engagement outcomes.

Scores range from 0 to 1. Scores are standardized so that the control group always has a mean score of 0 and standard deviation of 1. Higher scores reflect better outcomes---here, better engagement with the program. Scores composite results from multiple survey questions while adjusting for covariance between questions.

Outcome measures

Measure	Control Group-Begin Later n=171 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=164 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Engagement Index Score 6 months after trial enrollment	0 score on a scale Standard Deviation 1	0.4018523 score on a scale Standard Deviation 0.8282961
Engagement Index Score 12 months after trial enrollment	0 score on a scale Standard Deviation 1	0.000623 score on a scale Standard Deviation 0.8280342

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.

Healthcare utilization: Number of outpatient claims among continuously enrolled/insured subjects during the relevant time frame after trial enrollment.

Outcome measures

Measure	Control Group-Begin Later n=235 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=230 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Number of Outpatient Visits Claimed by Insurance 6 months after trial enrollment	4.86383 Number of claims Standard Deviation 4.628804	5.765217 Number of claims Standard Deviation 4.884394
Number of Outpatient Visits Claimed by Insurance 12 months after trial enrollment	10.07234 Number of claims Standard Deviation 8.314793	10.1 Number of claims Standard Deviation 8.088674

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.

Healthcare utilization: Number of inpatient and emergency department claims among continuously enrolled/insured subjects during the relevant time frame after enrollment.

Outcome measures

Measure	Control Group-Begin Later n=235 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=230 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Number of Inpatient and Emergency Department Visits Claimed by Insurance 6 months after trial enrollment	0.7914894 Number of claims Standard Deviation 1.680434	0.6869565 Number of claims Standard Deviation 1.363051
Number of Inpatient and Emergency Department Visits Claimed by Insurance 12 months after trial enrollment	1.497872 Number of claims Standard Deviation 3.350436	1.221739 Number of claims Standard Deviation 2.116365

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.

The number of subjects who were continuously enrolled/insured who had any outpatient claims during the relevant time frame after trial enrollment. For statistical analyses, coefficients and errors represent proportions of participants, relative to the size of the group/treatment arm.

Outcome measures

Measure	Control Group-Begin Later n=235 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=230 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Proportion of Participants Filing Outpatient Insurance Claims With Insurance 6 months after trial enrollment	207 Participants	215 Participants
Proportion of Participants Filing Outpatient Insurance Claims With Insurance 12 months after trial enrollment	224 Participants	221 Participants

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.

The number of subjects who were continuously enrolled/insured who had any inpatient or emergency department claims during the relevant time frame after trial enrollment. For statistical analyses, coefficients and errors represent proportions of participants, relative to the size of the group/treatment arm.

Outcome measures

Measure	Control Group-Begin Later n=235 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=230 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance 6 months after trial enrollment	84 Participants	70 Participants
Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance 12 months after trial enrollment	110 Participants	96 Participants

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.

Healthcare utilization: Total value (USD) of inpatient and emergency department payments among continuously enrolled/insured subjects during the relevant time frame after enrollment.

Outcome measures

Measure	Control Group-Begin Later n=96 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=105 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Inpatient and Emergency Department Payments 6 months after trial enrollment	2161.593 USD Standard Deviation 5284.944	2175.39 USD Standard Deviation 6176.236
Inpatient and Emergency Department Payments 12 months after trial enrollment	4545.119 USD Standard Deviation 9951.439	3284.667 USD Standard Deviation 7850.193

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

Population: Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.

Healthcare utilization: Value (USD) of outpatient payments among continuously enrolled/insured subjects during the relevant time frame after enrollment.

Outcome measures

Measure	Control Group-Begin Later n=96 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=105 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Outpatient Payments 6 months after trial enrollment	2023.022 USD Standard Deviation 3492.728	3313.627 USD Standard Deviation 6553.01
Outpatient Payments 12 months after trial enrollment	4117.954 USD Standard Deviation 5205.939	5327.305 USD Standard Deviation 7561.854

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

The number of times an individual participant completed a medical appointment with a dietician in the relevant time frame, based on electronic health records.

Outcome measures

Measure	Control Group-Begin Later n=235 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=230 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Number of Visits to a Dietician 6 months after trial enrollment	0.6212766 number of visits Standard Deviation 1.263041	2.656522 number of visits Standard Deviation 1.745694
Number of Visits to a Dietician 12 months after trial enrollment	2.919149 number of visits Standard Deviation 2.701269	4.53913 number of visits Standard Deviation 3.029079

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

The number of times an individual participant completed a Diabetes Self-Management Training (DSMT) in the relevant time frame, based on electronic health records.

Outcome measures

Measure	Control Group-Begin Later n=235 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=230 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Number of Diabetes Self-Management Trainings Completed 6 months after trial enrollment	0.3617021 number of trainings Standard Deviation 0.7168763	2.243478 number of trainings Standard Deviation 1.439258
Number of Diabetes Self-Management Trainings Completed 12 months after trial enrollment	2.140425 number of trainings Standard Deviation 1.888297	3.791304 number of trainings Standard Deviation 2.498893

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

The number of times an individual participant completed a medical appointment with an endocrinologist in the relevant time frame, based on electronic health records.

Outcome measures

Measure	Control Group-Begin Later n=235 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=230 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Number of Visits to an Endocrinologist 6 months after trial enrollment	0.4808511 number of appointments Standard Deviation 0.7970668	0.5913044 number of appointments Standard Deviation 0.8605437
Number of Visits to an Endocrinologist 12 months after trial enrollment	0.8893617 number of appointments Standard Deviation 1.302731	1.095652 number of appointments Standard Deviation 1.468588

SECONDARY outcome

Timeframe: 6 and 12 months after trial enrollment

The number of times an individual participant completed a medical appointment regarding weight loss or weight management in the relevant time frame, based on electronic health records.

Outcome measures

Measure	Control Group-Begin Later n=235 Participants Group 2- Will be randomized to the control ("Begin Later") group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial).	Treatment Group-Begin Now n=230 Participants Group 1- Will be randomized to the treatment ("Begin Now") group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total). Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Number of Weight Loss and Weight Management Appointments Completed 6 months after trial enrollment	0.1106383 number of appointments Standard Error 0.5193825	0.0521739 number of appointments Standard Error 0.3457409
Number of Weight Loss and Weight Management Appointments Completed 12 months after trial enrollment	0.2212766 number of appointments Standard Error 0.9707113	0.0521739 number of appointments Standard Error 0.3457409

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Healthy behaviors observed in electronic health record, including preventive care and appointments kept

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Healthy behaviors observed in paid claims using Healthcare Effectiveness Data and Information Set (HEDIS) measures. These measures were not collected for this study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

HbA1c available in EHR records

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Weight in pounds as available in EHR records

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

BMI in kg/m^2 in pounds as available in EHR records

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Cholesterol as available in EHR records

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Blood pressure as available in EHR records

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Triglycerides as available in EHR records

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Fasting glucose as available in EHR records

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Inpatient utilization for household members as available in EHR records

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Outpatient utilization for household members as available in EHR records

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Inpatient utilization for household members as available in paid claims

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Outpatient utilization for household members as available in paid claims

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Separate results by tercile of baseline HbA1c

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Heterogeneity analysis by site of the clinic

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Heterogeneity analysis by causal trees using the baseline characteristics to explore heterogeneity, sample size permitting.

Outcome measures

Outcome data not reported

Adverse Events

Treatment Group-Begin Now

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group-Begin Later

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph doyle

MIT Sloan School of Management

Phone: 6174523761

Email: jjdoyle@mit.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place