Type 2 DiabetesNCT03718832
Fresh Food Farmacy: A Randomized Controlled Trial
A study testing Fresh Food Farmacy in people with Type 2 Diabetes, run by John B Bulger, DO at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Fresh Food Farmacy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Apr 2019to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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:
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fresh Food Farmacy
Lewistown, Pennsylvania, 17044
Fresh Food Farmacy
Scranton, Pennsylvania, 18508
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Fresh Food Farmacy
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Food FarmacyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group-Begin Now | Experimental | 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). Receives: Other: Fresh Food Farmacy |
| Control Group-Begin Later | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after trial enrollment
Secondary outcomes (27)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 and 12 months after trial enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start22 Apr 2019
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- John B Bulger, DO
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology, Cornell University, Stanford University, Geisinger Clinic
- Responsible party
- Sponsor-investigator, John B Bulger, DO, Geisinger Clinic
- Investigators
- John Bulger, MD, Principal investigator, Geisinger ClinicJoseph J Doyle, Principal investigator, MIT Sloan School of Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718832
- Sponsor's protocol ID
- 2018-0297
- Status last verified
- May 2025
- First submitted
- 17 Oct 2018
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data at the subject level, pending approval from the IRB and Geisinger.
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.
PubMed 38147326
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fresh Food Farmacy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03718832
- Acronym / sponsor ID
- 2018-0297
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- John B Bulger, DOUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology, Cornell University, Stanford University, Geisinger Clinic
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Posted 12 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group-Begin Now | Experimental | Other: Fresh Food FarmacyGroup 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). |
| Control Group-Begin Later | No intervention | –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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh Food FarmacyPatients 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. | Other | Treatment Group-Begin Now |
Primary outcome
HbA1c
Time frame: 6 months after trial 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.
27 secondary outcomes
HbA1c
Time frame: 12 months after trial enrollment
Fasting Glucose
Time frame: 6 and 12 months after trial enrollment
Weight (lb)
Time frame: 6 and 12 months after trial enrollment
Body Mass Index
Time frame: 6 and 12 months after trial enrollment
Total Cholesterol
Time frame: 6 and 12 months after trial enrollment
LDL Cholesterol
Time frame: 6 and 12 months after trial enrollment
HDL Cholesterol
Time frame: 6 and 12 months after trial enrollment
Triglycerides
Time frame: 6 and 12 months after trial enrollment
Systolic Blood Pressure
Time frame: 6 and 12 months after trial enrollment
Diastolic Blood Pressure
Time frame: 6 and 12 months after trial enrollment
Times Eating Fruit in the Past 7 Days
Time frame: 6 and 12 months after trial enrollment
Times Eating Dark Green Vegetables in the Past 7 Days
Time frame: 6 and 12 months after trial enrollment
Times Drinking Sweetened Beverages in the Past 7 Days
Time frame: 6 and 12 months after trial enrollment
Times Eating Out in the Past 7 Days
Time frame: 6 and 12 months after trial enrollment
Participants Answering "Yes" for Diet Improvement Compared to One Year Ago
Time frame: 6 and 12 months after trial enrollment
Mean Proportion of Diabetes Knowledge Questions Answered Correctly
Time frame: 6 and 12 months after trial enrollment
Engagement Index Score
Time frame: 6 and 12 months after trial enrollment
Number of Outpatient Visits Claimed by Insurance
Time frame: 6 and 12 months after trial enrollment
Number of Inpatient and Emergency Department Visits Claimed by Insurance
Time frame: 6 and 12 months after trial enrollment
Proportion of Participants Filing Outpatient Insurance Claims With Insurance
Time frame: 6 and 12 months after trial enrollment
Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance
Time frame: 6 and 12 months after trial enrollment
Inpatient and Emergency Department Payments
Time frame: 6 and 12 months after trial enrollment
Outpatient Payments
Time frame: 6 and 12 months after trial enrollment
Number of Visits to a Dietician
Time frame: 6 and 12 months after trial enrollment
Number of Diabetes Self-Management Trainings Completed
Time frame: 6 and 12 months after trial enrollment
Number of Visits to an Endocrinologist
Time frame: 6 and 12 months after trial enrollment
Number of Weight Loss and Weight Management Appointments Completed
Time frame: 6 and 12 months after trial enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38147326Doyle 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.
- Individual participant dataSharing planned: Yes. Deidentified data at the subject level, pending approval from the IRB and Geisinger.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Bulger, MD principal investigator
Geisinger Clinic
Joseph J Doyle principal investigator
MIT Sloan School of Management
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh Food Farmacy in people with Type 2 Diabetes, run by John B Bulger, DO at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 6 months after trial enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03718832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.