The Feeding America Intervention Trial for Health-Diabetes Mellitus (FAITH-DM) is a randomized, controlled study of the implementation of a diabetes intervention in food pantry settings.
For adults with diabetes mellitus, diabetes self-management education (DSME) is critical to achieving long-term control of blood sugar levels (glycemic control) and preventing diabetes-associated complications. This education is often difficult to access for highly vulnerable and marginalized adults in the United States. Furthermore, foods for a diabetic diet are often out of reach for food insecure households. The purpose of this study is to determine the extent to which food banks and food pantries can help reach this population with effective DSME, food, and access to primary health care. The investigators' primary outcome of interest is HbA1c improvement in the intervention group compared to a wait-listed control group of food pantry clients living with uncontrolled type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
568
Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals
Referral to a local primary care provider, if none currently exists. Coordination of care with primary care provider.
Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.
Alameda County Community Food Bank
Oakland, California, United States
University of California San Francisco
San Francisco, California, United States
Gleaners Community Food Bank of Southeastern Michigan
Detroit, Michigan, United States
Houston Food Bank
Houston, Texas, United States
Change from Baseline HbA1c at 6 Months
Point-of-care HbA1c testing with the PTS Diagnostics A1CNow®+ System
Time frame: 6 months
Change from Baseline Dietary Intake
Brief fruit \& vegetable dietary screener
Time frame: 6 months and 12 months
Change from Baseline Health Care Utilization
Communication with primary care provider requesting dates of service, service levels, and diagnosis codes
Time frame: 6 months and 12 months
Change from Baseline Diabetes Distress
Self-reported distress as assessed by the 2-item emotional burden sub-score of the Diabetes Distress Scale
Time frame: 6 months and 12 months
Change from Baseline Hypoglycemic events
Self-reported hypoglycemic events over the previous 4 weeks, both any events and number of events, and self-reported severe hypoglycemic episodes, both any events and number of events
Time frame: 6 months and 12 months
Change from Baseline Depressive symptoms
PHQ-8 (a subset of PHQ-9 scores without assessment of suicidality)
Time frame: 6 months and 12 months
Change from Baseline Medication Adherence
Morisky Medication Adherence Scale (4 items)
Time frame: 6 months and 12 months
Food vs medicine trade-offs
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Education materials drawn from evidence-based practice and adapted from existing diabetes education curricula to be flexible to individual, community, and site variations. The Immediate Intervention Arm receives more robust diabetes self-management education (with group education visits) than the Waitlist Control Arm.
Three self-reported questions
Time frame: 6 months and 12 months
Change from Baseline Food security status
6-item version of the USDA's Core Food Security Survey Module
Time frame: 6 months and 12 months
Change from Baseline Food stability
Two items assessing adequacy of food resources to last the entire month
Time frame: 6 months and 12 months