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Fresh Food Farmacy: A Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03718832
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : April 15, 2020
Sponsor:
Collaborators:
Massachusetts Institute of Technology
Cornell University
Stanford University
Geisinger Clinic
Information provided by (Responsible Party):
John B Bulger, DO, Geisinger Clinic

Tracking Information
First Submitted Date  ICMJE October 17, 2018
First Posted Date  ICMJE October 25, 2018
Last Update Posted Date April 15, 2020
Actual Study Start Date  ICMJE April 22, 2019
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
HbA1c [ Time Frame: Measured at 6 months after trial enrollment ]
HbA1c measures blood sugar control
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
  • HbA1c [ Time Frame: Measured at 12 months after trial enrollment for all subjects and at 3 months for those whose measurements are available. ]
    HbA1c measures blood sugar control over the prior three months
  • Fasting glucose [ Time Frame: 6 months and 12 months ]
    Fasting glucose measures blood sugar control over a shorter time horizon
  • Weight [ Time Frame: 6 months and 12 months ]
    Weight in pounds
  • Body Mass Index [ Time Frame: 6 months and 12 months ]
    Body Mass Index in kg/m^2
  • Total Cholesterol [ Time Frame: 6 months and 12 months ]
    Total Cholesterol
  • LDL Cholesterol [ Time Frame: 6 months and 12 months ]
    LDL Cholesterol
  • Blood pressure (systolic and diastolic) [ Time Frame: 6 months and 12 months ]
    Blood pressure
  • Triglycerides [ Time Frame: 6 months and 12 months ]
    Triglycerides
  • Patient survey questions on self-assessed health, wellbeing, attitudes toward healthy behavior, self-efficacy, and patient satisfaction [ Time Frame: 6 months and 12 months ]
    Survey questions for the research study will be examined individually and in groups of questions.
  • Healthcare utilization [ Time Frame: 6 months and 12 months ]
    Heatlhcare utilization, including inpatient, ED and outpatient measures in patients' electronic health record
  • Healthcare utilization [ Time Frame: 3 months, 6 months and 12 months ]
    Heatlhcare utilization, including inpatient, ED and outpatient measures in patients' paid claims
  • Healthy behaviors observed in electronic health record [ Time Frame: 6 months and 12 months ]
    Healthy behaviors observed in electronic health record, including preventive care and appointments kept
  • Healthy behaviors observed in paid claims HEDIS measures [ Time Frame: 6 months and 12 months ]
    HEDIS measures of preventive care
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 23, 2018)
  • HbA1c for household members [ Time Frame: 6 months and 12 months ]
    HbA1c available in EHR records
  • Weight for household members [ Time Frame: 6 months and 12 months ]
    Weight in pounds as available in EHR records
  • BMI for household members [ Time Frame: 6 months and 12 months ]
    BMI in kg/m^2 in pounds as available in EHR records
  • Cholesterol for household members [ Time Frame: 6 months and 12 months ]
    Cholesterol as available in EHR records
  • Blood pressure for household members [ Time Frame: 6 months and 12 months ]
    Blood pressure as available in EHR records
  • Triglycerides for household members [ Time Frame: 6 months and 12 months ]
    Triglycerides as available in EHR records
  • Fasting glucose for household members [ Time Frame: 6 months and 12 months ]
    Fasting glucose as available in EHR records
  • Inpatient utilization for household members in EHR Records [ Time Frame: 6 months and 12 months ]
    Inpatient utilization for household members as available in EHR records
  • Outpatient utilization for household members in EHR Records [ Time Frame: 6 months and 12 months ]
    Outpatient utilization for household members as available in EHR records
  • Inpatient utilization for household members in paid claims [ Time Frame: 6 months and 12 months ]
    Inpatient utilization for household members as available in paid claims
  • Outpatient utilization for household members in paid claims [ Time Frame: 6 months and 12 months ]
    Outpatient utilization for household members as available in paid claims
  • Heterogeneity: HbA1c by baseline level of HbA1c [ Time Frame: 6 months and 12 months ]
    Separate results by tercile of baseline HbA1c
  • Heterogeneity: HbA1c by site [ Time Frame: 6 months and 12 months ]
    Heterogeneity analysis by site of the clinic
  • Heterogeneity: HbA1c by causal tree [ Time Frame: 6 months and 12 months ]
    Heterogeneity analysis by causal trees using the baseline characteristics to explore heterogeneity, sample size permitting.
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.

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
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.
Study Arms  ICMJE
  • 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).
    Intervention: Other: Fresh Food Farmacy
  • 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2018)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: John Bulger, MD 5702718713 jbulger@geisinger.edu
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified data at the subject level, pending approval from the IRB and Geisinger.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Analytic Code
Time Frame: Available pending approval from the IRB and after primary publication.
Access Criteria: To be determined
Responsible Party John B Bulger, DO, Geisinger Clinic
Study Sponsor  ICMJE John B Bulger, DO
Collaborators  ICMJE
  • Massachusetts Institute of Technology
  • Cornell University
  • Stanford University
  • Geisinger Clinic
Investigators  ICMJE
Principal Investigator: John Bulger, MD Geisinger Clinic
Principal Investigator: Joseph J Doyle MIT Sloan School of Management
PRS Account Geisinger Clinic
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP