Fresh Food Farmacy: A Randomized Controlled Trial

This trial investigates the value created by the highly innovative Fresh Food Farmacy (FFF) program at Geisinger Health. The program provides food-insecure diabetics with healthy food for their entire household: at least two meals per day, five days a week. The program also provides education on how to prepare the food, and education on healthy living including diabetes self management. The research measures the effects of the FFF program on patient health and wellbeing.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Fresh Food Farmacy

Detailed Description

This is a pragmatic, prospective, randomized controlled trial of Geisinger's Fresh Food Farmacy (FFF) program as the program expands to new sites. Qualifying subjects will be randomized 1:1 to receive either early participation in the FFF program (treatment group) or later participation (control group).

Approximately 500 Geisinger subjects will participate in this study with about half assigned to the treatment group and about half to the control group. The treatment group will begin the program soon after trial recruitment: the "Begin Now" group. The control group will begin the program after 6 months: the "Begin Later" group. Approximately 2000 household members will be included in the data-only portion of the research.

Outcomes will include clinical measures, such as HbA1c, survey responses including self-assessed health measures, and utilization / healthy-behavior measures from EHR and paid claims data. These will be measured for subjects and their household members.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Lewistown, Pennsylvania, United States, 17044
      • Fresh Food Farmacy
    • Scranton, Pennsylvania, United States, 18508
      • Fresh Food Farmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Type II Diabetes and an HbA1c ≥ 8.0 as determined by the most recent measurement in the Geisinger EMR within the prior 12 months
• Food insecure based on a two-question survey instrument
• Age > 17 & Age <86
• Living within geographic reach of the program (Lewistown, PA and Scranton, PA)

Exclusion Criteria:

• Already enrolled in FFF in Shamokin
• Not English speaking (working on changing this as the program evolves)
• On hospice or palliative care
• Acute or chronic psychosis
• Resides in a facility which provides meals

• Active medical disorder that would preclude participation in the classes, weekly clinic visits, or result in a limited diet, including:

  • Cancer; active treatment
  • Steroid dependent asthma/ COPD/ emphysema
  • Steroid dependent Colitis
  • Chronic Kidney Disease with GFR< 30 mg/mmol
  • Celiac disease
  • Cirrhosis
  • Steroid dependent arthritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: 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.
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	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.	6 months after trial enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	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.	12 months after trial enrollment
Fasting Glucose	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.	6 and 12 months after trial enrollment
Weight (lb)	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.	6 and 12 months after trial enrollment
Body Mass Index	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.	6 and 12 months after trial enrollment
Total Cholesterol	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.	6 and 12 months after trial enrollment
LDL Cholesterol	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.	6 and 12 months after trial enrollment
HDL Cholesterol	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.	6 and 12 months after trial enrollment
Triglycerides	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.	6 and 12 months after trial enrollment
Systolic Blood Pressure	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.	6 and 12 months after trial enrollment
Diastolic Blood Pressure	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.	6 and 12 months after trial enrollment
Times Eating Fruit in the Past 7 Days	Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate fruit.	6 and 12 months after trial enrollment
Times Eating Dark Green Vegetables in the Past 7 Days	Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate dark green vegetables.	6 and 12 months after trial enrollment
Times Drinking Sweetened Beverages in the Past 7 Days	Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient drank sweetened beverages.	6 and 12 months after trial enrollment
Times Eating Out in the Past 7 Days	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.	6 and 12 months after trial enrollment
Participants Answering "Yes" for Diet Improvement Compared to One Year Ago	Patient-reported measure of diet improvement: Survey question: "Do you believe your diet has improved compared to one year ago?".	6 and 12 months after trial enrollment
Mean Proportion of Diabetes Knowledge Questions Answered Correctly	The proportion of questions testing patients' knowledge of how different factors contribute to blood sugar answered correctly.	6 and 12 months after trial enrollment
Engagement Index Score	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.	6 and 12 months after trial enrollment
Number of Outpatient Visits Claimed by Insurance	Healthcare utilization: Number of outpatient claims among continuously enrolled/insured subjects during the relevant time frame after trial enrollment.	6 and 12 months after trial enrollment
Number of Inpatient and Emergency Department Visits Claimed by Insurance	Healthcare utilization: Number of inpatient and emergency department claims among continuously enrolled/insured subjects during the relevant time frame after enrollment.	6 and 12 months after trial enrollment
Proportion of Participants Filing Outpatient Insurance Claims With Insurance	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.	6 and 12 months after trial enrollment
Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance	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.	6 and 12 months after trial enrollment
Inpatient and Emergency Department Payments	Healthcare utilization: Total value (USD) of inpatient and emergency department payments among continuously enrolled/insured subjects during the relevant time frame after enrollment.	6 and 12 months after trial enrollment
Outpatient Payments	Healthcare utilization: Value (USD) of outpatient payments among continuously enrolled/insured subjects during the relevant time frame after enrollment.	6 and 12 months after trial enrollment
Number of Visits to a Dietician	The number of times an individual participant completed a medical appointment with a dietician in the relevant time frame, based on electronic health records.	6 and 12 months after trial enrollment
Number of Diabetes Self-Management Trainings Completed	The number of times an individual participant completed a Diabetes Self-Management Training (DSMT) in the relevant time frame, based on electronic health records.	6 and 12 months after trial enrollment
Number of Visits to an Endocrinologist	The number of times an individual participant completed a medical appointment with an endocrinologist in the relevant time frame, based on electronic health records.	6 and 12 months after trial enrollment
Number of Weight Loss and Weight Management Appointments Completed	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.	6 and 12 months after trial enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthy Behaviors Observed in Electronic Health Record	Healthy behaviors observed in electronic health record, including preventive care and appointments kept	6 months and 12 months
Healthy Behaviors Observed in Paid Claims HEDIS Measures	Healthy behaviors observed in paid claims using Healthcare Effectiveness Data and Information Set (HEDIS) measures. These measures were not collected for this study.	6 months and 12 months
HbA1c for Household Members	HbA1c available in EHR records	6 months and 12 months
Weight for Household Members	Weight in pounds as available in EHR records	6 months and 12 months
BMI for Household Members	BMI in kg/m^2 in pounds as available in EHR records	6 months and 12 months
Cholesterol for Household Members	Cholesterol as available in EHR records	6 months and 12 months
Blood Pressure for Household Members	Blood pressure as available in EHR records	6 months and 12 months
Triglycerides for Household Members	Triglycerides as available in EHR records	6 months and 12 months
Fasting Glucose for Household Members	Fasting glucose as available in EHR records	6 months and 12 months
Inpatient Utilization for Household Members in EHR Records	Inpatient utilization for household members as available in EHR records	6 months and 12 months
Outpatient Utilization for Household Members in EHR Records	Outpatient utilization for household members as available in EHR records	6 months and 12 months
Inpatient Utilization for Household Members in Paid Claims	Inpatient utilization for household members as available in paid claims	6 months and 12 months
Outpatient Utilization for Household Members in Paid Claims	Outpatient utilization for household members as available in paid claims	6 months and 12 months
Heterogeneity: HbA1c by Baseline Level of HbA1c	Separate results by tercile of baseline HbA1c	6 months and 12 months
Heterogeneity: HbA1c by Site	Heterogeneity analysis by site of the clinic	6 months and 12 months
Heterogeneity: HbA1c by Causal Tree	Heterogeneity analysis by causal trees using the baseline characteristics to explore heterogeneity, sample size permitting.	6 months and 12 months

Collaborators and Investigators

• Sponsor: John B Bulger, DO
• Collaborators: Massachusetts Institute of Technology; Stanford University; Geisinger Clinic; Cornell University
• Investigators: Principal Investigator: John Bulger, MD, Geisinger Clinic; Principal Investigator: Joseph J Doyle, MIT Sloan School of Management

Publications and helpful links

General Publications

• Doyle J, Alsan M, Skelley N, Lu Y, Cawley J. Effect of an Intensive Food-as-Medicine Program on Health and Health Care Use: A Randomized Clinical Trial. JAMA Intern Med. 2024 Feb 1;184(2):154-163. doi: 10.1001/jamainternmed.2023.6670.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes
• Other Study ID Numbers: 2018-0297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data at the subject level, pending approval from the IRB and Geisinger.
• IPD Sharing Time Frame: Available pending approval from the IRB and after primary publication.
• IPD Sharing Access Criteria: To be determined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: doi:10.7910/DVN/LZUTU0
2. Analytic Code
   Information identifier: doi:10.7910/DVN/LZUTU0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No