Fresh Food Farmacy: A Randomized Controlled Trial
- 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
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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)
-
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 Measured at 6 months after trial enrollment HbA1c measures blood sugar control
- Secondary Outcome Measures
Name Time Method LDL Cholesterol 6 months and 12 months LDL Cholesterol
HbA1c 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 6 months and 12 months Fasting glucose measures blood sugar control over a shorter time horizon
Patient survey questions on self-assessed health, wellbeing, attitudes toward healthy behavior, self-efficacy, and patient satisfaction 6 months and 12 months Survey questions for the research study will be examined individually and in groups of questions.
Healthcare utilization 3 months, 6 months and 12 months Heatlhcare utilization, including inpatient, ED and outpatient measures in patients' paid claims
Weight 6 months and 12 months Weight in pounds
Body Mass Index 6 months and 12 months Body Mass Index in kg/m\^2
Total Cholesterol 6 months and 12 months Total Cholesterol
Triglycerides 6 months and 12 months Triglycerides
Blood pressure (systolic and diastolic) 6 months and 12 months Blood pressure
Healthy behaviors observed in electronic health record 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 6 months and 12 months HEDIS measures of preventive care
Trial Locations
- Locations (1)
Fresh Food Farmacy
🇺🇸Scranton, Pennsylvania, United States