Fresh Food Farmacy: A Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Fresh Food Farmacy

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Lewistown, Pennsylvania, United States, 17044
      • Fresh Food Farmacy
    • Scranton, Pennsylvania, United States, 18508
      • Fresh Food Farmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c measures blood sugar control	Measured at 6 months after trial enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c measures blood sugar control over the prior three months	Measured at 12 months after trial enrollment for all subjects and at 3 months for those whose measurements are available.
Fasting glucose	Fasting glucose measures blood sugar control over a shorter time horizon	6 months and 12 months
Weight	Weight in pounds	6 months and 12 months
Body Mass Index	Body Mass Index in kg/m^2	6 months and 12 months
Total Cholesterol	Total Cholesterol	6 months and 12 months
LDL Cholesterol	LDL Cholesterol	6 months and 12 months
Blood pressure (systolic and diastolic)	Blood pressure	6 months and 12 months
Triglycerides	Triglycerides	6 months and 12 months
Patient survey questions on self-assessed health, wellbeing, attitudes toward healthy behavior, self-efficacy, and patient satisfaction	Survey questions for the research study will be examined individually and in groups of questions.	6 months and 12 months
Healthcare utilization	Heatlhcare utilization, including inpatient, ED and outpatient measures in patients' electronic health record	6 months and 12 months
Healthcare utilization	Heatlhcare utilization, including inpatient, ED and outpatient measures in patients' paid claims	3 months, 6 months and 12 months
Healthy behaviors observed in electronic health record	Healthy behaviors observed in electronic health record, including preventive care and appointments kept	6 months and 12 months
Healthy behaviors observed in paid claims HEDIS measures	HEDIS measures of preventive care	6 months and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c for household members	HbA1c available in EHR records	6 months and 12 months
Weight for household members	Weight in pounds as available in EHR records	6 months and 12 months
BMI for household members	BMI in kg/m^2 in pounds as available in EHR records	6 months and 12 months
Cholesterol for household members	Cholesterol as available in EHR records	6 months and 12 months
Blood pressure for household members	Blood pressure as available in EHR records	6 months and 12 months
Triglycerides for household members	Triglycerides as available in EHR records	6 months and 12 months
Fasting glucose for household members	Fasting glucose as available in EHR records	6 months and 12 months
Inpatient utilization for household members in EHR Records	Inpatient utilization for household members as available in EHR records	6 months and 12 months
Outpatient utilization for household members in EHR Records	Outpatient utilization for household members as available in EHR records	6 months and 12 months
Inpatient utilization for household members in paid claims	Inpatient utilization for household members as available in paid claims	6 months and 12 months
Outpatient utilization for household members in paid claims	Outpatient utilization for household members as available in paid claims	6 months and 12 months
Heterogeneity: HbA1c by baseline level of HbA1c	Separate results by tercile of baseline HbA1c	6 months and 12 months
Heterogeneity: HbA1c by site	Heterogeneity analysis by site of the clinic	6 months and 12 months
Heterogeneity: HbA1c by causal tree	Heterogeneity analysis by causal trees using the baseline characteristics to explore heterogeneity, sample size permitting.	6 months and 12 months

Collaborators and Investigators

• Sponsor: John B Bulger, DO
• Collaborators: Massachusetts Institute of Technology; Stanford University; Geisinger Clinic; Cornell University
• Investigators: Principal Investigator: John Bulger, MD, Geisinger Clinic; Principal Investigator: Joseph J Doyle, MIT Sloan School of Management

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes
• Other Study ID Numbers: 2018-0297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data at the subject level, pending approval from the IRB and Geisinger.
• IPD Sharing Time Frame: Available pending approval from the IRB and after primary publication.
• IPD Sharing Access Criteria: To be determined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No