Fresh Food Farmacy: A Randomized Controlled Trial

NCT03718832 | Completed Results

• 1 other identifier: 2018-0297
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Type 2 Diabetes

Keywords

Diabetes

Outcome Measures

Primary Outcomes (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.

  6 months after trial enrollment

Secondary Outcomes (27)

• HbA1c

  12 months after trial enrollment

• Fasting Glucose

  6 and 12 months after trial enrollment

• Weight (lb)

  6 and 12 months after trial enrollment

• Body Mass Index

  6 and 12 months after trial enrollment

• Total Cholesterol

  6 and 12 months after trial enrollment

Other Outcomes (16)

• Healthy Behaviors Observed in Electronic Health Record

  6 months and 12 months

• Healthy Behaviors Observed in Paid Claims HEDIS Measures

  6 months and 12 months

• HbA1c for Household Members

  6 months and 12 months

Study Arms (2)

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).

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).

Interventions

Fresh Food Farmacy OTHER

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.

Treatment Group-Begin Now

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• John B Bulger, DO: lead
• Massachusetts Institute of Technology: collaborator
• Cornell University: collaborator
• Stanford University: collaborator
• Geisinger Clinic: collaborator

Study Sites (2)

Fresh Food Farmacy

Lewistown, Pennsylvania, 17044, United States

Location

Fresh Food Farmacy

Scranton, Pennsylvania, 18508, United States

Location

Related Publications (1)

• 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.

  PMID: 38147326 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

1. Pandemic timeperiod: Estimates were similar, though modestly powered, using only pre-pandemic data. 2. Effects may differ at other health systems / patients who are not well connect to a system. 3. Wait list design: control group members may take additional actions due to awareness of the program. 4. Lack of detailed recall measures. 5. It may take longer than 6-12 months for the intervention to change these outcomes.

Results Point of Contact

• Title: Joseph doyle
• Organization: MIT Sloan School of Management

jjdoyle@mit.edu

6174523761

Study Officials

• John Bulger, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

• Joseph J Doyle

  MIT Sloan School of Management

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Health Officer, GIO

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 25, 2018
• Study Start: April 22, 2019
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Available pending approval from the IRB and after primary publication.
• Access Criteria: To be determined

Locations

US (2)