NCT02569060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
568

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

2.1 years

First QC Date

October 2, 2015

Last Update Submit

May 14, 2020

Conditions

Diabetes Mellitus

Keywords

diabetes mellituscommunity interventioninterventionrandomizeddietary interventionself-management supportfood bank

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline HbA1c at 6 Months

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

    6 months

Secondary Outcomes (9)

  • Change from Baseline Dietary Intake

    6 months and 12 months

  • Change from Baseline Health Care Utilization

    6 months and 12 months

  • Change from Baseline Diabetes Distress

    6 months and 12 months

  • Change from Baseline Hypoglycemic events

    6 months and 12 months

  • Change from Baseline Depressive symptoms

    6 months and 12 months

  • +4 more secondary outcomes

Other Outcomes (2)

  • Change from Baseline Diabetes Self-Efficacy

    6 months and 12 months

  • Change from Baseline Diabetes Self-Care

    6 months and 12 months

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

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 LevelsOther: Primary care coordinationOther: Diabetes-appropriate food packagesBehavioral: Diabetes self-management education

Waitlist Control

ACTIVE COMPARATOR

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 LevelsOther: Primary care coordinationOther: Diabetes-appropriate food packagesBehavioral: Diabetes self-management education

Interventions

Testing and Monitoring of Blood Glucose LevelsOTHER

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

Immediate InterventionWaitlist Control
Primary care coordinationOTHER

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

Immediate InterventionWaitlist Control
Diabetes-appropriate food packagesOTHER

Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.

Immediate InterventionWaitlist Control
Diabetes self-management educationBEHAVIORAL

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.

Immediate InterventionWaitlist Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age or older
  • Intent to remain in the study area for at least the next 12 months
  • Willingness to participate in intervention

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Alameda County Community Food Bank

Oakland, California, 94614, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Gleaners Community Food Bank of Southeastern Michigan

Detroit, Michigan, 48207, United States

Location

Houston Food Bank

Houston, Texas, 77029, United States

Location

Related Publications (3)

  • 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.

    PMID: 35415385DERIVED

  • 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.

    PMID: 33416608DERIVED

  • 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.

    PMID: 30024798DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hilary K Seligman, MD MAS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2015

First Posted

October 6, 2015

Study Start

October 1, 2015

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

May 18, 2020

Record last verified: 2020-05

Locations

US(4)