Clinical trial NCT03718832: Fresh Food Farmacy: A Randomized Controlled Trial
Official title: Fresh Food Farmacy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
name: Cornell University
name: Stanford University
name: Geisinger Clinic
First posted: 2018-10-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: 6 months after trial enrollment
Secondary outcomes:
measure: HbA1c
timeFrame: 12 months after trial enrollment
measure: Fasting Glucose
timeFrame: 6 and 12 months after trial enrollment
measure: Weight (lb)
timeFrame: 6 and 12 months after trial enrollment
measure: Body Mass Index
timeFrame: 6 and 12 months after trial enrollment
measure: Total Cholesterol
timeFrame: 6 and 12 months after trial enrollment
measure: LDL Cholesterol
timeFrame: 6 and 12 months after trial enrollment
measure: HDL Cholesterol
timeFrame: 6 and 12 months after trial enrollment
measure: Triglycerides
timeFrame: 6 and 12 months after trial enrollment
measure: Systolic Blood Pressure
timeFrame: 6 and 12 months after trial enrollment
measure: Diastolic Blood Pressure
timeFrame: 6 and 12 months after trial enrollment
measure: Times Eating Fruit in the Past 7 Days
timeFrame: 6 and 12 months after trial enrollment
measure: Times Eating Dark Green Vegetables in the Past 7 Days
timeFrame: 6 and 12 months after trial enrollment
measure: Times Drinking Sweetened Beverages in the Past 7 Days
timeFrame: 6 and 12 months after trial enrollment
measure: Times Eating Out in the Past 7 Days
timeFrame: 6 and 12 months after trial enrollment
measure: Participants Answering "Yes" for Diet Improvement Compared to One Year Ago
timeFrame: 6 and 12 months after trial enrollment
measure: Mean Proportion of Diabetes Knowledge Questions Answered Correctly
timeFrame: 6 and 12 months after trial enrollment
measure: Engagement Index Score
timeFrame: 6 and 12 months after trial enrollment
measure: Number of Outpatient Visits Claimed by Insurance
timeFrame: 6 and 12 months after trial enrollment
measure: Number of Inpatient and Emergency Department Visits Claimed by Insurance
timeFrame: 6 and 12 months after trial enrollment
measure: Proportion of Participants Filing Outpatient Insurance Claims With Insurance
timeFrame: 6 and 12 months after trial enrollment
measure: Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance
timeFrame: 6 and 12 months after trial enrollment
measure: Inpatient and Emergency Department Payments
timeFrame: 6 and 12 months after trial enrollment
measure: Outpatient Payments
timeFrame: 6 and 12 months after trial enrollment
measure: Number of Visits to a Dietician
timeFrame: 6 and 12 months after trial enrollment
measure: Number of Diabetes Self-Management Trainings Completed
timeFrame: 6 and 12 months after trial enrollment
measure: Number of Visits to an Endocrinologist
timeFrame: 6 and 12 months after trial enrollment
measure: Number of Weight Loss and Weight Management Appointments Completed
timeFrame: 6 and 12 months after trial enrollment
Other outcomes:
measure: Healthy Behaviors Observed in Electronic Health Record
timeFrame: 6 months and 12 months
measure: Healthy Behaviors Observed in Paid Claims HEDIS Measures
timeFrame: 6 months and 12 months
measure: HbA1c for Household Members
timeFrame: 6 months and 12 months
measure: Weight for Household Members
timeFrame: 6 months and 12 months
measure: BMI for Household Members
timeFrame: 6 months and 12 months
measure: Cholesterol for Household Members
timeFrame: 6 months and 12 months
measure: Blood Pressure for Household Members
timeFrame: 6 months and 12 months
measure: Triglycerides for Household Members
timeFrame: 6 months and 12 months
measure: Fasting Glucose for Household Members
timeFrame: 6 months and 12 months
measure: Inpatient Utilization for Household Members in EHR Records
timeFrame: 6 months and 12 months
measure: Outpatient Utilization for Household Members in EHR Records
timeFrame: 6 months and 12 months
measure: Inpatient Utilization for Household Members in Paid Claims
timeFrame: 6 months and 12 months
measure: Outpatient Utilization for Household Members in Paid Claims
timeFrame: 6 months and 12 months
measure: Heterogeneity: HbA1c by Baseline Level of HbA1c
timeFrame: 6 months and 12 months
measure: Heterogeneity: HbA1c by Site
timeFrame: 6 months and 12 months
measure: Heterogeneity: HbA1c by Causal Tree
timeFrame: 6 months and 12 months
Locations:
city: Lewistown
country: United States
facility: Fresh Food Farmacy
state: Pennsylvania
city: Scranton
country: United States
facility: Fresh Food Farmacy
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: John Bulger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MIT Sloan School of Management
name: Joseph J Doyle
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doyle J, Alsan M, Skelley N, Lu Y, Cawley J. Effect of an Intensive Food-as-Medicine Program on Health and Health Care Use: A Randomized Clinical Trial. JAMA Intern Med. 2024 Feb 1;184(2):154-163. doi: 10.1001/jamainternmed.2023.6670.