Fresh Food Farmacy: A Randomized Controlled Trial

Part of paid clinical trials in Lewistown, Pennsylvania.

Sponsor
John B Bulger, DO
Study ID
NCT03718832
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 22, 2019
Status verified
May 2025
Primary completion
Nov 30, 2023
Completion
Nov 30, 2023

Study Design

Enrollment
500 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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).
  • 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).

Primary Outcome Measure

HbA1c [ Time Frame: 6 months after trial enrollment ]

Locations (2)

FacilityCityStateZIPSite coordinators
Fresh Food FarmacyLewistownPennsylvania17044-
Fresh Food FarmacyScrantonPennsylvania18508-

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