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 — OTHERPatients 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 NowGroup 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 LaterGroup 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fresh Food Farmacy | Lewistown | Pennsylvania | 17044 | - |
| Fresh Food Farmacy | Scranton | Pennsylvania | 18508 | - |
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