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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT03718832
Study groupRoleWhat they receive
Treatment Group-Begin NowExperimentalGroup 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 LaterNo interventionGroup 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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.

  1. First posted25 Oct 2018
  2. Study start22 Apr 2019
  3. Primary completion30 Nov 2023
  4. Study completion30 Nov 2023

Resources

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)
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
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

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.

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