Feeding America Intervention Trial for Health--Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

568 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-10-31

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.

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate Intervention

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

Group Type EXPERIMENTAL

Testing and Monitoring of Blood Glucose Levels

Intervention Type OTHER

Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals

Primary care coordination

Intervention Type OTHER

Referral to a local primary care provider, if none currently exists. Coordination of care with primary care provider.

Diabetes-appropriate food packages

Intervention Type OTHER

Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.

Diabetes self-management education

Intervention Type BEHAVIORAL

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.

Waitlist Control

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

Group Type ACTIVE_COMPARATOR

Testing and Monitoring of Blood Glucose Levels

Intervention Type OTHER

Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals

Primary care coordination

Intervention Type OTHER

Referral to a local primary care provider, if none currently exists. Coordination of care with primary care provider.

Diabetes-appropriate food packages

Intervention Type OTHER

Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.

Diabetes self-management education

Intervention Type BEHAVIORAL

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.

Interventions

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Testing and Monitoring of Blood Glucose Levels

Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals

Intervention Type OTHER

Primary care coordination

Referral to a local primary care provider, if none currently exists. Coordination of care with primary care provider.

Intervention Type OTHER

Diabetes-appropriate food packages

Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.

Intervention Type OTHER

Diabetes self-management education

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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes