Feeding America Intervention Trial for Health--Diabetes Mellitus (FAITH-DM)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: Primary care coordination; Other: Testing and Monitoring of Blood Glucose Levels; Other: Diabetes-appropriate food packages; Behavioral: Diabetes self-management education

Study type: Interventional

Funder types: Other

Identifiers

NCT02569060

A125548

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 568 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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568 participants in 2 patient groups

Immediate Intervention

Experimental group

Description:

Participants randomized to the Intervention Arm will immediately begin a four-component intervention. 1. Testing and monitoring of blood glucose levels 2. Referral to and/or coordination with primary care provider 3. Diabetes-appropriate food packages 4. Diabetes self-management education and support

Treatment:

Other: Testing and Monitoring of Blood Glucose Levels

Other: Primary care coordination

Other: Diabetes-appropriate food packages

Behavioral: Diabetes self-management education

Waitlist Control

Active Comparator group

Description:

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. 1. Testing and monitoring of blood glucose levels 2. Referral to and/or coordination with primary care provider 3. Diabetes-appropriate food packages 4. Limited diabetes self-management education and support

Treatment:

Other: Testing and Monitoring of Blood Glucose Levels

Other: Primary care coordination

Other: Diabetes-appropriate food packages

Behavioral: Diabetes self-management education