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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Testing and Monitoring of Blood Glucose Levels; Other: Primary care coordination; Other: Diabetes-appropriate food packages; Behavioral: Diabetes self-management education

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 Type: Interventional
• Enrollment (Actual): 568
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94614
      • Alameda County Community Food Bank
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Michigan
    • Detroit, Michigan, United States, 48207
      • Gleaners Community Food Bank of Southeastern Michigan
  • Texas
    • Houston, Texas, United States, 77029
      • Houston Food Bank

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline HbA1c at 6 Months	Point-of-care HbA1c testing with the PTS Diagnostics A1CNow®+ System	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Dietary Intake	Brief fruit & vegetable dietary screener	6 months and 12 months
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
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
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
Change from Baseline Depressive symptoms	PHQ-8 (a subset of PHQ-9 scores without assessment of suicidality)	6 months and 12 months
Change from Baseline Medication Adherence	Morisky Medication Adherence Scale (4 items)	6 months and 12 months
Food vs medicine trade-offs	Three self-reported questions	6 months and 12 months
Change from Baseline Food security status	6-item version of the USDA's Core Food Security Survey Module	6 months and 12 months
Change from Baseline Food stability	Two items assessing adequacy of food resources to last the entire month	6 months and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Diabetes Self-Efficacy	8-item scale of diabetes-specific self-efficacy	6 months and 12 months
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Urban Institute; Laura and John Arnold Foundation; Feeding America
• Investigators: Principal Investigator: Hilary K Seligman, MD MAS, University of California, San Francisco

Publications and helpful links

General Publications

• Seligman HK, Levi R, Ridberg R, Smith M, Hills N, Waxman E. Impact of Enhanced Food Pantry Services on Food Security among Adults with Diabetes Using a Crossover Study Design. Curr Dev Nutr. 2022 Feb 10;6(4):nzac021. doi: 10.1093/cdn/nzac021. eCollection 2022 Apr.
• Smith M, Rosenmoss S, Seligman HK. Point-of-Care Hemoglobin A1C Testing System in Community Settings: Challenges, Opportunities, and Measurement Characteristics. Prog Community Health Partnersh. 2020;14(3):327-335. doi: 10.1353/cpr.2020.0038.
• Seligman HK, Smith M, Rosenmoss S, Marshall MB, Waxman E. Comprehensive Diabetes Self-Management Support From Food Banks: A Randomized Controlled Trial. Am J Public Health. 2018 Sep;108(9):1227-1234. doi: 10.2105/AJPH.2018.304528. Epub 2018 Jul 19.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: October 2, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimate): October 6, 2015

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: intervention; diabetes mellitus; randomized; dietary intervention; community intervention; self-management support; food bank
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: A125548