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Fresh Food Farmacy: A Randomized Controlled Trial

Last registered on April 23, 2019
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Pre-Trial

Trial Information

General Information

Title
Fresh Food Farmacy: A Randomized Controlled Trial
RCT ID
AEARCTR-0004098
Initial registration date
April 10, 2019

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
April 22, 2019, 11:31 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
April 23, 2019, 10:49 AM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Country
United States of America
Region
Pennsylvania

Primary Investigator

Name
Joseph Doyle
Affiliation
MIT
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Other Primary Investigator(s)

PI Name
John Bulger
PI Affiliation
Geisinger Health
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Additional Trial Information

Status
On going
Start date
2019-04-22
End date
2022-12-31
Keywords
Health
Additional Keywords
Diabetes; Food as Medicine
JEL code(s)
I12
Secondary IDs
ClinicalTrials.gov Identifier: NCT03718832
Abstract
We will conduct a randomized controlled trial to estimate the impact of Geisinger Health’s Fresh Food Farmacy program (FFF). The program brings a “food-as-medicine” approach to address a key social determinant of health (food insecurity) for patients with diabetes. A Fresh Food Farmacy dietitian prescribes enough fresh food for two meals per day, five days per week, for everyone in the patient’s household. Prescriptions for the food are filled once a week at no charge at a local clinic. Complementary services include dietitian consultation, recipes, cooking classes, biometric tracking, diabetes self-management training and checks that participants are following best practices such as eye and foot exams. By randomly assigning patients to either start the FFF program immediately or in six months, we will be able to estimate the impact of the FFF program on a wide range of clinical outcomes, healthy behaviors, measures of wellbeing, and health care utilization.
External Link(s)

Registration Citation

Citation
Bulger, John and Joseph Doyle. 2019. "Fresh Food Farmacy: A Randomized Controlled Trial." AEA RCT Registry. April 23. https://doi.org/10.1257/rct.4098-2.0
Former Citation
Bulger, John and Joseph Doyle. 2019. "Fresh Food Farmacy: A Randomized Controlled Trial." AEA RCT Registry. April 23. https://www.socialscienceregistry.org/trials/4098/history/45397
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
We will conduct a randomized controlled trial to estimate the impact of Geisinger Health’s Fresh Food Farmacy program (FFF). The program brings a “food-as-medicine” approach to address a key social determinant of health (food insecurity) for patients with diabetes. A Fresh Food Farmacy dietitian prescribes enough fresh food for two meals per day, five days per week, for everyone in the patient’s household. Prescriptions for the food are filled once a week at no charge at a local clinic. Complementary services include dietitian consultation, recipes, cooking classes, biometric tracking, diabetes self-management training and checks that participants are following best practices such as eye and foot exams. By randomly assigning patients to either start the FFF program immediately or in six months, we will be able to estimate the impact of the FFF program on a wide range of clinical outcomes, healthy behaviors, measures of wellbeing, and health care utilization.
Intervention Start Date
2019-04-22
Intervention End Date
2021-12-31

Primary Outcomes

Primary Outcomes (end points)
6-month HbA1c
Primary Outcomes (explanation)
HbA1c is a clinically meaningful biomarker of health for patients with diabetes and strongly correlated with downstream utilization.

Secondary Outcomes

Secondary Outcomes (end points)
6-month outcomes:
fasting glucose, weight, BMI, blood pressure, total cholesterol, LDL cholesterol, and triglycerides.
survey responses covering diet, exercise, and other healthy behaviors, self-efficacy, self-assessed physical and mental health, and patient satisfaction
healthcare utilization (inpatient, outpatient, ED and pharmaceutical usage)
healthy behaviors: keeping appointments, drug adherence
Secondary Outcomes (explanation)
See analysis plan.

Experimental Design

Experimental Design
Patients are recruited and randomized to begin the program or wait 6 months. The randomization is stratified by location and level of HbA1c.
Experimental Design Details
See analysis plan.
Randomization Method
Recruitment staff will discover whether the patient is randomized to start now or start later in a tamper proof REDCap application, which consults a randomized allocation table that the recruiter cannot access and a treatment status that is locked along with the patient’s identifying information and study ID.
Randomization Unit
Individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
500 individuals
Sample size: planned number of observations
500 individuals
Sample size (or number of clusters) by treatment arms
250 in treatment, 250 in control
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
3.7% reduction in HbA1c (17% of a standard deviation) with 80% power and size of 5%.
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
Geisinger
IRB Approval Date
2019-01-15
IRB Approval Number
2018-0297
Analysis Plan

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Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials