Fresh Food Farmacy: A Randomized Controlled Trial

Type 2 Diabetes Clinical Trial

Official title:

Fresh Food Farmacy: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03718832
• Other study ID #: 2018-0297
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 22, 2019
• Est. completion date: November 30, 2023

Study information

• Verified date: July 2023
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Fresh Food Farmacy	Lewistown	Pennsylvania
United States	Fresh Food Farmacy	Scranton	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
John B Bulger, DO	Cornell University, Geisinger Clinic, Massachusetts Institute of Technology, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HbA1c for household members	HbA1c available in EHR records	6 months and 12 months
Other	Weight for household members	Weight in pounds as available in EHR records	6 months and 12 months
Other	BMI for household members	BMI in kg/m^2 in pounds as available in EHR records	6 months and 12 months
Other	Cholesterol for household members	Cholesterol as available in EHR records	6 months and 12 months
Other	Blood pressure for household members	Blood pressure as available in EHR records	6 months and 12 months
Other	Triglycerides for household members	Triglycerides as available in EHR records	6 months and 12 months
Other	Fasting glucose for household members	Fasting glucose as available in EHR records	6 months and 12 months
Other	Inpatient utilization for household members in EHR Records	Inpatient utilization for household members as available in EHR records	6 months and 12 months
Other	Outpatient utilization for household members in EHR Records	Outpatient utilization for household members as available in EHR records	6 months and 12 months
Other	Inpatient utilization for household members in paid claims	Inpatient utilization for household members as available in paid claims	6 months and 12 months
Other	Outpatient utilization for household members in paid claims	Outpatient utilization for household members as available in paid claims	6 months and 12 months
Other	Heterogeneity: HbA1c by baseline level of HbA1c	Separate results by tercile of baseline HbA1c	6 months and 12 months
Other	Heterogeneity: HbA1c by site	Heterogeneity analysis by site of the clinic	6 months and 12 months
Other	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
Primary	HbA1c	HbA1c measures blood sugar control	Measured at 6 months after trial enrollment
Secondary	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.
Secondary	Fasting glucose	Fasting glucose measures blood sugar control over a shorter time horizon	6 months and 12 months
Secondary	Weight	Weight in pounds	6 months and 12 months
Secondary	Body Mass Index	Body Mass Index in kg/m^2	6 months and 12 months
Secondary	Total Cholesterol	Total Cholesterol	6 months and 12 months
Secondary	LDL Cholesterol	LDL Cholesterol	6 months and 12 months
Secondary	Blood pressure (systolic and diastolic)	Blood pressure	6 months and 12 months
Secondary	Triglycerides	Triglycerides	6 months and 12 months
Secondary	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
Secondary	Healthcare utilization	Heatlhcare utilization, including inpatient, ED and outpatient measures in patients' electronic health record	6 months and 12 months
Secondary	Healthcare utilization	Heatlhcare utilization, including inpatient, ED and outpatient measures in patients' paid claims	3 months, 6 months and 12 months
Secondary	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
Secondary	Healthy behaviors observed in paid claims HEDIS measures	HEDIS measures of preventive care	6 months and 12 months