Feeding America Intervention Trial for Health--Diabetes Mellitus

Diabetes Mellitus Clinical Trial

— FAITH-DM  

Official title:

Feeding America Intervention Trial for Health--Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569060
• Other study ID #: A125548
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 31, 2017

Study information

• Verified date: May 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• 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.

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.

Locations

Country	Name	City	State
United States	Gleaners Community Food Bank of Southeastern Michigan	Detroit	Michigan
United States	Houston Food Bank	Houston	Texas
United States	Alameda County Community Food Bank	Oakland	California
United States	University of California San Francisco	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Feeding America, Laura and John Arnold Foundation, Urban Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline Diabetes Self-Efficacy	8-item scale of diabetes-specific self-efficacy	6 months and 12 months
Other	Change from Baseline Diabetes Self-Care	Self-reported assessment of 5 self-care behaviors: medications, exercise, diet, blood sugar monitoring, and foot care	6 months and 12 months
Primary	Change from Baseline HbA1c at 6 Months	Point-of-care HbA1c testing with the PTS Diagnostics A1CNow®+ System	6 months
Secondary	Change from Baseline Dietary Intake	Brief fruit & vegetable dietary screener	6 months and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from Baseline Depressive symptoms	PHQ-8 (a subset of PHQ-9 scores without assessment of suicidality)	6 months and 12 months
Secondary	Change from Baseline Medication Adherence	Morisky Medication Adherence Scale (4 items)	6 months and 12 months
Secondary	Food vs medicine trade-offs	Three self-reported questions	6 months and 12 months
Secondary	Change from Baseline Food security status	6-item version of the USDA's Core Food Security Survey Module	6 months and 12 months
Secondary	Change from Baseline Food stability	Two items assessing adequacy of food resources to last the entire month	6 months and 12 months