Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatments testing and monitoring of blood glucose levels, primary care coordination, diabetes-appropriate food packages, diabetes self-management education
Sponsor University of California, San Francisco
Collaborator Feeding America
Start date October 2015
End date October 2017
Trial size 572 participants
Trial identifier NCT02569060, A125548

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
testing and monitoring of blood glucose levels
Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals
primary care coordination
Referral to a local primary care provider, if none currently exists. Coordination of care with primary care provider.
diabetes-appropriate food packages
Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.
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.
(Active Comparator)
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
testing and monitoring of blood glucose levels
Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals
primary care coordination
Referral to a local primary care provider, if none currently exists. Coordination of care with primary care provider.
diabetes-appropriate food packages
Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.
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.

Primary Outcomes

Measure
Change from Baseline HbA1c at 6 Months
time frame: 6 months

Secondary Outcomes

Measure
Change from Baseline Dietary Intake
time frame: 6 months and 12 months
Change from Baseline Health Care Utilization
time frame: 6 months and 12 months
Change from Baseline Diabetes Distress
time frame: 6 months and 12 months
Change from Baseline Hypoglycemic events
time frame: 6 months and 12 months
Change from Baseline Depressive symptoms
time frame: 6 months and 12 months
Change from Baseline Medication Adherence
time frame: 6 months and 12 months
Food vs medicine trade-offs
time frame: 6 months and 12 months
Change from Baseline Food security status
time frame: 6 months and 12 months
Change from Baseline Food stability
time frame: 6 months and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Feeding America Intervention Trial for Health--Diabetes Mellitus
Principal investigator Hilary K Seligman, MD MAS
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.