FAITH-DM: Feeding America Intervention Trial for Health--Diabetes Mellitus

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT02569060

Collaborator

Feeding America (Other), Laura and John Arnold Foundation (Other), Urban Institute (Other)

568

Enrollment

Locations

Arms

Actual Duration (Months)

142

Patients Per Site

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Other: Testing and Monitoring of Blood Glucose Levels Other: Primary care coordination Other: Diabetes-appropriate food packages Behavioral: Diabetes self-management education	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

568 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Feeding America Intervention Trial for Health--Diabetes Mellitus

Actual Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Oct 31, 2017

Actual Study Completion Date :

Oct 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate Intervention 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 Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals Other: Primary care coordination Referral to a local primary care provider, if none currently exists. Coordination of care with primary care provider. 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. Behavioral: 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: 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. 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 Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals Other: Primary care coordination Referral to a local primary care provider, if none currently exists. Coordination of care with primary care provider. 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. Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Immediate Intervention

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

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

Other: Primary care coordination

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

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.

Behavioral: 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: 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. 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

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

Other: Primary care coordination

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

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.

Behavioral: Diabetes self-management education

Outcome Measures

Primary Outcome Measures

Change from Baseline HbA1c at 6 Months [6 months]
Point-of-care HbA1c testing with the PTS Diagnostics A1CNow®+ System

Secondary Outcome Measures

Change from Baseline Dietary Intake [6 months and 12 months]
Brief fruit & vegetable dietary screener
Change from Baseline Health Care Utilization [6 months and 12 months]
Communication with primary care provider requesting dates of service, service levels, and diagnosis codes
Change from Baseline Diabetes Distress [6 months and 12 months]
Self-reported distress as assessed by the 2-item emotional burden sub-score of the Diabetes Distress Scale
Change from Baseline Hypoglycemic events [6 months and 12 months]
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
Change from Baseline Depressive symptoms [6 months and 12 months]
PHQ-8 (a subset of PHQ-9 scores without assessment of suicidality)
Change from Baseline Medication Adherence [6 months and 12 months]
Morisky Medication Adherence Scale (4 items)
Food vs medicine trade-offs [6 months and 12 months]
Three self-reported questions
Change from Baseline Food security status [6 months and 12 months]
6-item version of the USDA's Core Food Security Survey Module
Change from Baseline Food stability [6 months and 12 months]
Two items assessing adequacy of food resources to last the entire month

Other Outcome Measures

Change from Baseline Diabetes Self-Efficacy [6 months and 12 months]
8-item scale of diabetes-specific self-efficacy
Change from Baseline Diabetes Self-Care [6 months and 12 months]
Self-reported assessment of 5 self-care behaviors: medications, exercise, diet, blood sugar monitoring, and foot care

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alameda County Community Food Bank	Oakland	California	United States	94614
2	University of California San Francisco	San Francisco	California	United States	94143
3	Gleaners Community Food Bank of Southeastern Michigan	Detroit	Michigan	United States	48207
4	Houston Food Bank	Houston	Texas	United States	77029