Fresh Food Farmacy: A Randomized Controlled Trial

NCT ID: NCT03718832

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-22
• Study Completion Date: 2023-11-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Fresh Food Farmacy

Intervention Type: 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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts Institute of Technology

OTHER

Sponsor Role: collaborator

Cornell University

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

Geisinger Clinic

OTHER

Sponsor Role: collaborator

John B Bulger, DO

OTHER

Sponsor Role: lead

Responsible Party

John B Bulger, DO

Chief Health Officer, GIO

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John Bulger, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Joseph J Doyle

Role: PRINCIPAL_INVESTIGATOR

MIT Sloan School of Management

Locations

Fresh Food Farmacy

Lewistown, Pennsylvania, United States

Fresh Food Farmacy

Scranton, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 38147326 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Study Documents

Document Type: Individual Participant Data Set

View Document

Document Type: Analytic Code

View Document

Other Identifiers

2018-0297

Identifier Type: -

Identifier Source: org_study_id