Fresh Food Farmacy: A Randomized Controlled Trial

John B Bulger, DO

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: Fresh Food Farmacy

Study type: Interventional

Funder types: Other

Identifiers

NCT03718832

2018-0297

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Treatment Group-Begin Now

Experimental group

Description:

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).

Treatment:

Other: Fresh Food Farmacy

Control Group-Begin Later

No Intervention group

Description:

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).