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NCT Number: NCT02569060

Feeding America Intervention Trial for Health--Diabetes Mellitus

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alameda County Community Food Bank, Oakland, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testing and Monitoring of Blood Glucose Levels

Other

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

Primary care coordination

Other

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

Diabetes-appropriate food packages

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

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.

Primary outcomes

  1. Change from Baseline HbA1c at 6 Months

    Time frame: 6 months

    Point-of-care HbA1c testing with the PTS Diagnostics A1CNow®+ System

Secondary outcomes

  1. Change from Baseline Dietary Intake

    Time frame: 6 months and 12 months

    Brief fruit & vegetable dietary screener

  2. Change from Baseline Health Care Utilization

    Time frame: 6 months and 12 months

    Communication with primary care provider requesting dates of service, service levels, and diagnosis codes

  3. Change from Baseline Diabetes Distress

    Time frame: 6 months and 12 months

    Self-reported distress as assessed by the 2-item emotional burden sub-score of the Diabetes Distress Scale

  4. Change from Baseline Hypoglycemic events

    Time frame: 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

  5. Change from Baseline Depressive symptoms

    Time frame: 6 months and 12 months

    PHQ-8 (a subset of PHQ-9 scores without assessment of suicidality)

  6. Change from Baseline Medication Adherence

    Time frame: 6 months and 12 months

    Morisky Medication Adherence Scale (4 items)

  7. Food vs medicine trade-offs

    Time frame: 6 months and 12 months

    Three self-reported questions

  8. Change from Baseline Food security status

    Time frame: 6 months and 12 months

    6-item version of the USDA's Core Food Security Survey Module

  9. Change from Baseline Food stability

    Time frame: 6 months and 12 months

    Two items assessing adequacy of food resources to last the entire month

Other outcomes

  1. Change from Baseline Diabetes Self-Efficacy

    Time frame: 6 months and 12 months

    8-item scale of diabetes-specific self-efficacy

  2. Change from Baseline Diabetes Self-Care

    Time frame: 6 months and 12 months

    Self-reported assessment of 5 self-care behaviors: medications, exercise, diet, blood sugar monitoring, and foot care

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Feeding America
  • Laura and John Arnold Foundation
  • Urban Institute

Registry information

Acronym: FAITH-DM

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 6, 2015
Registry last updated
May 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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