Fresh Food Farmacy: A Randomized Controlled Trial
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ClinicalTrials.gov Identifier: NCT03718832 |
Recruitment Status :
Active, not recruiting
First Posted : October 25, 2018
Last Update Posted : August 2, 2023
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | October 17, 2018 | ||||||||||||||
First Posted Date ICMJE | October 25, 2018 | ||||||||||||||
Last Update Posted Date | August 2, 2023 | ||||||||||||||
Actual Study Start Date ICMJE | April 22, 2019 | ||||||||||||||
Estimated Primary Completion Date | November 30, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
HbA1c [ Time Frame: Measured at 6 months after trial enrollment ] HbA1c measures blood sugar control
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Fresh Food Farmacy: A Randomized Controlled Trial | ||||||||||||||
Official Title ICMJE | Fresh Food Farmacy: A Randomized Controlled Trial | ||||||||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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Condition ICMJE | Type 2 Diabetes | ||||||||||||||
Intervention ICMJE | Other: 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.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||
Actual Enrollment ICMJE |
500 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | November 30, 2023 | ||||||||||||||
Estimated Primary Completion Date | November 30, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT03718832 | ||||||||||||||
Other Study ID Numbers ICMJE | 2018-0297 | ||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | John B Bulger, DO, Geisinger Clinic | ||||||||||||||
Original Responsible Party | Andrea Feinberg, Geisinger Clinic, Chief Health Officer, Geisinger Innovations | ||||||||||||||
Current Study Sponsor ICMJE | John B Bulger, DO | ||||||||||||||
Original Study Sponsor ICMJE | Andrea Feinberg | ||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Geisinger Clinic | ||||||||||||||
Verification Date | July 2023 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |