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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569060
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : May 18, 2020
Sponsor:
Collaborators:
Feeding America
Laura and John Arnold Foundation
Urban Institute
Information provided by (Responsible Party):
University of California, San Francisco

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2015
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Arm Intervention/treatment
Experimental: Immediate Intervention

Participants randomized to the Intervention Arm will immediately begin a four-component intervention.

  1. Testing and monitoring of blood glucose levels
  2. Referral to and/or coordination with primary care provider
  3. Diabetes-appropriate food packages
  4. 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.

  1. Testing and monitoring of blood glucose levels
  2. Referral to and/or coordination with primary care provider
  3. Diabetes-appropriate food packages
  4. 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.




Primary Outcome Measures :
  1. Change from Baseline HbA1c at 6 Months [ Time Frame: 6 months ]
    Point-of-care HbA1c testing with the PTS Diagnostics A1CNow®+ System


Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569060


Locations
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United States, California
Alameda County Community Food Bank
Oakland, California, United States, 94614
University of California San Francisco
San Francisco, California, United States, 94143
United States, Michigan
Gleaners Community Food Bank of Southeastern Michigan
Detroit, Michigan, United States, 48207
United States, Texas
Houston Food Bank
Houston, Texas, United States, 77029
Sponsors and Collaborators
University of California, San Francisco
Feeding America
Laura and John Arnold Foundation
Urban Institute
Investigators
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Principal Investigator: Hilary K Seligman, MD MAS University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02569060    
Other Study ID Numbers: A125548
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Keywords provided by University of California, San Francisco:
diabetes mellitus
community intervention
intervention
randomized
dietary intervention
self-management support
food bank
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases