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Diabetes MellitusFAITH-DMNCT02569060

Feeding America Intervention Trial for Health--Diabetes Mellitus

A study testing Testing and Monitoring of Blood Glucose Levels, Primary care coordination and Diabetes-appropriate food packages in people with Diabetes Mellitus, run by University of California, San Francisco at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus
What is being tested?
Testing and Monitoring of Blood Glucose Levels, Primary care coordination and Diabetes-appropriate food packages
Could I receive a placebo?
No, everyone receives an active treatment
How many people
568 participants
Where
4 sitesUnited States
Study dates
Oct 2015to 31 Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Gleaners Community Food Bank of Southeastern Michigan

    Detroit, Michigan, 48207

  • Houston Food Bank

    Houston, Texas, 77029

  • Alameda County Community Food Bank

    Oakland, California, 94614

  • University of California San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

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.

Read the 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.

Being tested
Testing and Monitoring of Blood Glucose Levels, Primary care coordination, Diabetes-appropriate food packages, Diabetes self-management education
Keywords
diabetes mellitus, community intervention, intervention, randomized, dietary intervention, self-management support, food bank
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Testing and Monitoring of Blood Glucose LevelsOther

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

  • Primary care coordinationOther

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

  • Diabetes-appropriate food packagesOther

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

  • Diabetes self-management educationBehavioural

    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.

Study groups in NCT02569060
Study groupRoleWhat they receive
Immediate InterventionExperimentalParticipants 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
Receives: Other: Testing and Monitoring of Blood Glucose Levels; Other: Primary care coordination; Other: Diabetes-appropriate food packages; Behavioral: Diabetes self-management education
Waitlist ControlActive comparatorParticipants 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
Receives: Other: Testing and Monitoring of Blood Glucose Levels; Other: Primary care coordination; Other: Diabetes-appropriate food packages; Behavioral: Diabetes self-management education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline HbA1c at 6 Months

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

    Measured: 6 months

Secondary outcomes (9)

  1. Change from Baseline Dietary Intake

    Brief fruit \& vegetable dietary screener

    Measured: 6 months and 12 months

  2. Change from Baseline Health Care Utilization

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

    Measured: 6 months and 12 months

  3. Change from Baseline Diabetes Distress

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

    Measured: 6 months and 12 months

  4. 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

    Measured: 6 months and 12 months

  5. Change from Baseline Depressive symptoms

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

    Measured: 6 months and 12 months

  6. Change from Baseline Medication Adherence

    Morisky Medication Adherence Scale (4 items)

    Measured: 6 months and 12 months

  7. Food vs medicine trade-offs

    Three self-reported questions

    Measured: 6 months and 12 months

  8. Change from Baseline Food security status

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

    Measured: 6 months and 12 months

  9. Change from Baseline Food stability

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

    Measured: 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completion31 Oct 2017
  4. Study completion31 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
568 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02569060
Sponsor's protocol ID
A125548
Acronym
FAITH-DM
Status last verified
May 2020
First submitted
2 Oct 2015
Last updated
18 May 2020
Results posted
No
Data monitoring committee
No

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.

    PubMed 35415385

  • 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.

    PubMed 33416608

  • 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.

    PubMed 30024798

Questions about this trial

What is this clinical trial studying?

A study testing Testing and Monitoring of Blood Glucose Levels, Primary care coordination and Diabetes-appropriate food packages in people with Diabetes Mellitus, run by University of California, San Francisco at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline HbA1c at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02569060, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.

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