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N/A N=500 Randomized Health Services Research

Fresh Food Farmacy: A Randomized Controlled Trial

Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT03718832 ↗
Enrolled (actual)
500
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: HbA1c — 8.781177; 8.814526 % of hemoglobin — p=0.8638688

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Fresh Food Farmacy (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
John B Bulger, DO
Primary completion
Nov 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
HbA1c		 8.735975; 8.595031 0.5039565
SECONDARY
HbA1c		 8.735975; 8.595031 0.5039565
SECONDARY
Fasting Glucose		 185.0236; 198.292; 185.4696; 172.3441 0.2247426
SECONDARY
Weight (lb)		 230.8205; 238.9561; 227.9171; 237.5989 0.1991028
SECONDARY
Body Mass Index		 36.77117; 37.6461; 36.20175; 37.65195 0.3502313
SECONDARY
Total Cholesterol		 170.3087; 160.5404; 164.8345; 165.3806 0.1007463
SECONDARY
LDL Cholesterol		 93.54835; 85.19621; 87.36268; 84.72519 0.0743062
SECONDARY
HDL Cholesterol		 41.27718; 41.8323; 42.34722; 43.73333 0.6976216
SECONDARY
Triglycerides		 223.5705; 201.0123; 212.7762; 224.1288 0.2045348
SECONDARY
Systolic Blood Pressure		 128.3118; 130.1823; 126.0235; 129.7956 0.356123
SECONDARY
Diastolic Blood Pressure		 74.2043; 74.76041; 74.48235; 73.98343 0.6091477
SECONDARY
Times Eating Fruit in the Past 7 Days		 5.564417; 5.241177; 5.097222; 5.79562 0.3823224
SECONDARY
Times Eating Dark Green Vegetables in the Past 7 Days		 6.288343; 4.011765; 4.202797; 5.782609 0.1650343
SECONDARY
Times Drinking Sweetened Beverages in the Past 7 Days		 2.777778; 3.407186; 2.377622; 2.550725 0.1544491
SECONDARY
Times Eating Out in the Past 7 Days		 4.5; 4.017544; 4.402778; 4.413043 0.2549037
SECONDARY
Participants Answering "Yes" for Diet Improvement Compared to One Year Ago		 153; 132; 137; 129 0.0000252 sig
SECONDARY
Mean Proportion of Diabetes Knowledge Questions Answered Correctly		 0.8267857; 0.7756302; 0.8271728; 0.8133472 0.0018721 sig
SECONDARY
Engagement Index Score		 0.4018523; 0; 0.000623; 0 0.0000743 sig
SECONDARY
Number of Outpatient Visits Claimed by Insurance		 5.765217; 4.86383; 10.1; 10.07234 0.0417413 sig
SECONDARY
Number of Inpatient and Emergency Department Visits Claimed by Insurance		 0.6869565; 0.7914894; 1.221739; 1.497872 0.4612408
SECONDARY
Proportion of Participants Filing Outpatient Insurance Claims With Insurance		 215; 207; 221; 224 0.0442418 sig
SECONDARY
Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance		 70; 84; 96; 110 0.2245167
SECONDARY
Inpatient and Emergency Department Payments		 2175.39; 2161.593; 3284.667; 4545.119 0.9864081
SECONDARY
Outpatient Payments		 3313.627; 2023.022; 5327.305; 4117.954 0.0795087
SECONDARY
Number of Visits to a Dietician		 2.656522; 0.6212766; 4.53913; 2.919149 <0.001 sig
SECONDARY
Number of Diabetes Self-Management Trainings Completed		 2.243478; 0.3617021; 3.791304; 2.140425 <0.001 sig
SECONDARY
Number of Visits to an Endocrinologist		 0.5913044; 0.4808511; 1.095652; 0.8893617 0.1519153
SECONDARY
Number of Weight Loss and Weight Management Appointments Completed		 0.0521739; 0.1106383; 0.0521739; 0.2212766 0.152918

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03718832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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