Fresh Food Farmacy: A Randomized Controlled Trial

Not Applicable

Completed

Conditions: Type 2 Diabetes

Interventions: Other: Fresh Food Farmacy

Registration Number: NCT03718832

Lead Sponsor: John B Bulger, DO

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 500

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group-Begin Now	Fresh Food Farmacy	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).

Primary Outcome Measures

Name	Time	Method
HbA1c	6 months after trial enrollment	Glycated hemoglobin (HbA1c) is a measure of the average share of glucose that has been in the bloodstream over the 2-3 months preceding measurement. HbA1c is measured by performing assays on samples of the participants' blood. Units are percentages; for differences between HbA1c values, units are percentage points. An HbA1c value of 6.5% is the lower threshold for type 2 diabetes. HbA1c values are rarely above 15-20%. In the context of this study (patients with type 2 diabetes), higher scores are considered a worse outcome.

Secondary Outcome Measures

Name	Time	Method
HbA1c	12 months after trial enrollment	Glycated hemoglobin. Units are percentages (for differences, percentage points) reflecting the average share of glucose in the bloodstream over the previous 2-3 months. An HbA1c value of 6.5% is the lower threshold for type 2 diabetes. HbA1c values are rarely above 15-20%. In the context of this study (patients with type 2 diabetes), higher scores are considered a worse outcome.
Fasting Glucose	6 and 12 months after trial enrollment	Fasting blood glucose is a measure of blood sugar control over a short time period (the blood glucose content after an overnight fast). Units are mg/dL. To convert to mmol/L (SI), multiply by 0.0113. Lower fasting blood glucose levels indicate better health within the context of this study.
Weight (lb)	6 and 12 months after trial enrollment	Weight in pounds. In the context of this study, higher values are considered a worse outcome. SI conversion factor: To convert pounds to kilograms, multiply by 0.4536.
Body Mass Index	6 and 12 months after trial enrollment	Body Mass Index (BMI) in kg/m\^2. BMI is computed using weight (lb) and height (in). The CDC's healthy reference range for BMI among adults aged 20 and older is 18.5 to 24.9. BMI values greater than or equal to 30.0 indicate obesity. In the context of this study, higher BMI is considered a worse outcome.
Total Cholesterol	6 and 12 months after trial enrollment	Total cholesterol in mg/dL. The CDC recommends total cholesterol levels around 150 mg/dL and classifies levels of 200 mg/dL and above as unhealthy (hyperlipidemia). In the context of this study, higher total cholesterol indicates a worse outcome. SI conversion factor: To convert from mg/dL to mmol/L, multiply by 0.0259.
LDL Cholesterol	6 and 12 months after trial enrollment	Low-density lipoprotein (LDL) cholesterol, measured in mg/dL. The CDC recommends LDL levels of 100 mg/dL or below. In the context of this study, higher levels of LDL indicate a worse outcome. SI conversion factor: To convert from mg/dL to mmol/L, multiply by 0.0259.
HDL Cholesterol	6 and 12 months after trial enrollment	High-density lipoprotein (HDL) cholesterol, measured in mg/dL. The CDC recommends HDL levels of at least 40 mg/dL in men and 50 mg/dL in women. In the context of this study, higher levels of HDL indicate a better outcome. SI conversion factor: To convert mg/dL to mmol/L, multiply by 0.0259.
Triglycerides	6 and 12 months after trial enrollment	Triglycerides, measured in mg/dL. The CDC recommends levels of triglycerides below 150 mg/dL. In the context of this study, higher levels of triglycerides indicate worse outcomes. SI conversion factor: To convert mg/dL to mmol/L, multiply by 0.0113.
Systolic Blood Pressure	6 and 12 months after trial enrollment	Systolic blood pressure, measured in mm Hg. The CDC identifies normal healthy systolic blood pressure as below 120 mm Hg. The American College of Cardiology identifies 120 to 129 mm Hg as elevated blood pressure and 130 mm Hg and higher as hypertensive. Higher systolic blood pressure levels indicate worse outcomes.
Diastolic Blood Pressure	6 and 12 months after trial enrollment	Diastolic blood pressure, measured in mm Hg. The American College of Cardiology identifies normal diastolic blood pressure as below 80 mm Hg and elevated/hypertensive diastolic blood pressure as 80 mm Hg or above. Higher levels of diastolic blood pressure indicate worse outcomes.
Times Eating Fruit in the Past 7 Days	6 and 12 months after trial enrollment	Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate fruit.
Times Eating Dark Green Vegetables in the Past 7 Days	6 and 12 months after trial enrollment	Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate dark green vegetables.
Times Drinking Sweetened Beverages in the Past 7 Days	6 and 12 months after trial enrollment	Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient drank sweetened beverages.
Times Eating Out in the Past 7 Days	6 and 12 months after trial enrollment	Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate fast food, takeout, or at a restaurant.
Participants Answering "Yes" for Diet Improvement Compared to One Year Ago	6 and 12 months after trial enrollment	Patient-reported measure of diet improvement: Survey question: "Do you believe your diet has improved compared to one year ago?".
Mean Proportion of Diabetes Knowledge Questions Answered Correctly	6 and 12 months after trial enrollment	The proportion of questions testing patients' knowledge of how different factors contribute to blood sugar answered correctly.
Engagement Index Score	6 and 12 months after trial enrollment	Survey-based index score for patient-reported positive engagement outcomes. Scores range from 0 to 1. Scores are standardized so that the control group always has a mean score of 0 and standard deviation of 1. Higher scores reflect better outcomes---here, better engagement with the program. Scores composite results from multiple survey questions while adjusting for covariance between questions.
Number of Outpatient Visits Claimed by Insurance	6 and 12 months after trial enrollment	Healthcare utilization: Number of outpatient claims among continuously enrolled/insured subjects during the relevant time frame after trial enrollment.
Number of Inpatient and Emergency Department Visits Claimed by Insurance	6 and 12 months after trial enrollment	Healthcare utilization: Number of inpatient and emergency department claims among continuously enrolled/insured subjects during the relevant time frame after enrollment.
Proportion of Participants Filing Outpatient Insurance Claims With Insurance	6 and 12 months after trial enrollment	The number of subjects who were continuously enrolled/insured who had any outpatient claims during the relevant time frame after trial enrollment. For statistical analyses, coefficients and errors represent proportions of participants, relative to the size of the group/treatment arm.
Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance	6 and 12 months after trial enrollment	The number of subjects who were continuously enrolled/insured who had any inpatient or emergency department claims during the relevant time frame after trial enrollment. For statistical analyses, coefficients and errors represent proportions of participants, relative to the size of the group/treatment arm.
Inpatient and Emergency Department Payments	6 and 12 months after trial enrollment	Healthcare utilization: Total value (USD) of inpatient and emergency department payments among continuously enrolled/insured subjects during the relevant time frame after enrollment.
Outpatient Payments	6 and 12 months after trial enrollment	Healthcare utilization: Value (USD) of outpatient payments among continuously enrolled/insured subjects during the relevant time frame after enrollment.
Number of Visits to a Dietician	6 and 12 months after trial enrollment	The number of times an individual participant completed a medical appointment with a dietician in the relevant time frame, based on electronic health records.
Number of Diabetes Self-Management Trainings Completed	6 and 12 months after trial enrollment	The number of times an individual participant completed a Diabetes Self-Management Training (DSMT) in the relevant time frame, based on electronic health records.
Number of Visits to an Endocrinologist	6 and 12 months after trial enrollment	The number of times an individual participant completed a medical appointment with an endocrinologist in the relevant time frame, based on electronic health records.
Number of Weight Loss and Weight Management Appointments Completed	6 and 12 months after trial enrollment	The number of times an individual participant completed a medical appointment regarding weight loss or weight management in the relevant time frame, based on electronic health records.