Feeding America Intervention Trial for Health--Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feeding America Intervention Trial for Health--Diabetes Mellitus

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: Testing and Monitoring of Blood Glucose Levels
* Other: Primary care coordination
* Other: Diabetes-appropriate food packages
* Behavioral: Diabetes self-management education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Food pantry client at one of three participating food banks: Alameda County Community Food Bank (Oakland, CA), Gleaners Community Food Bank of Southeastern Michigan (Detroit, MI), Houston Food Bank, (Houston, TX) Type II diabetes mellitus with HbA1c ≥ 7.5% using food bank point-of-care testing Reliable mode of contact (either phone or address) English or Spanish verbal fluency 18 years of age or older Intent to remain in the study area for at least the next 12 months Willingness to participate in intervention Exclusion Criteria: Type 1 diabetes Pregnant or less than 6 weeks post-partum Cognitively impaired: dementia, mental illness, or active substance abuse severe enough to interfere with administration of the survey or participation in the intervention Household member already enrolled in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention<br>Participants randomized to the Intervention Arm will immediately begin a four-component intervention. Testing and monitoring of blood glucose levels Referral to and/or coordination with primary care provider Diabetes-appropriate food packages Diabetes self-management education and support | Other: Testing and Monitoring of Blood Glucose Levels<br>* Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals<br>Other: Primary care coordination<br>* Referral to a local primary care provider, if none currently exists. Coordination of care with primary care provider.<br>Other: Diabetes-appropriate food packages<br>* Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.<br>Behavioral: Diabetes self-management education<br>* 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.<br>|
| Active Comparator: Waitlist Control<br>Participants randomized to the Waitlist Control arm will receive no intervention for six months, after which time they will begin a modified, four-component intervention. Testing and monitoring of blood glucose levels Referral to and/or coordination with primary care provider Diabetes-appropriate food packages Limited diabetes self-management education and support | Other: Testing and Monitoring of Blood Glucose Levels<br>* Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals<br>Other: Primary care coordination<br>* Referral to a local primary care provider, if none currently exists. Coordination of care with primary care provider.<br>Other: Diabetes-appropriate food packages<br>* Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.<br>Behavioral: Diabetes self-management education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline HbA1c at 6 Months | Point-of-care HbA1c testing with the PTS Diagnostics A1CNow®+ System | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Dietary Intake | Brief fruit & vegetable dietary screener | 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 | 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 | 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 | 6 months and 12 months | 
| Change from Baseline Depressive symptoms | PHQ-8 (a subset of PHQ-9 scores without assessment of suicidality) | 6 months and 12 months | 
| Change from Baseline Medication Adherence | Morisky Medication Adherence Scale (4 items) | 6 months and 12 months | 
| Food vs medicine trade-offs | Three self-reported questions | 6 months and 12 months | 
| Change from Baseline Food security status | 6-item version of the USDA's Core Food Security Survey Module | 6 months and 12 months | 
| Change from Baseline Food stability | Two items assessing adequacy of food resources to last the entire month | 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, community intervention, intervention, randomized, dietary intervention, self-management support, food bank