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

14. maj 2020 opdateret af: University of California, San Francisco
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

568

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Andet: Testing and Monitoring of Blood Glucose Levels
Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals
Andet: Primary care coordination
Referral to a local primary care provider, if none currently exists. Coordination of care with primary care provider.
Andet: Diabetes-appropriate food packages
Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.
Adfærdsmæssigt: 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.
Aktiv komparator: 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
Andet: Testing and Monitoring of Blood Glucose Levels
Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals
Andet: Primary care coordination
Referral to a local primary care provider, if none currently exists. Coordination of care with primary care provider.
Andet: Diabetes-appropriate food packages
Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline HbA1c at 6 Months
Tidsramme: 6 months
Point-of-care HbA1c testing with the PTS Diagnostics A1CNow®+ System
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline Dietary Intake
Tidsramme: 6 months and 12 months
Brief fruit & vegetable dietary screener
6 months and 12 months
Change from Baseline Health Care Utilization
Tidsramme: 6 months and 12 months
Communication with primary care provider requesting dates of service, service levels, and diagnosis codes
6 months and 12 months
Change from Baseline Diabetes Distress
Tidsramme: 6 months and 12 months
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
Tidsramme: 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
6 months and 12 months
Change from Baseline Depressive symptoms
Tidsramme: 6 months and 12 months
PHQ-8 (a subset of PHQ-9 scores without assessment of suicidality)
6 months and 12 months
Change from Baseline Medication Adherence
Tidsramme: 6 months and 12 months
Morisky Medication Adherence Scale (4 items)
6 months and 12 months
Food vs medicine trade-offs
Tidsramme: 6 months and 12 months
Three self-reported questions
6 months and 12 months
Change from Baseline Food security status
Tidsramme: 6 months and 12 months
6-item version of the USDA's Core Food Security Survey Module
6 months and 12 months
Change from Baseline Food stability
Tidsramme: 6 months and 12 months
Two items assessing adequacy of food resources to last the entire month
6 months and 12 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline Diabetes Self-Efficacy
Tidsramme: 6 months and 12 months
8-item scale of diabetes-specific self-efficacy
6 months and 12 months
Change from Baseline Diabetes Self-Care
Tidsramme: 6 months and 12 months
Self-reported assessment of 5 self-care behaviors: medications, exercise, diet, blood sugar monitoring, and foot care
6 months and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Samarbejdspartnere

Urban Institute
Laura and John Arnold Foundation
Feeding America

Efterforskere

  • Ledende efterforsker: Hilary K Seligman, MD MAS, University of California, San Francisco

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2015

Primær færdiggørelse (Faktiske)

31. oktober 2017

Studieafslutning (Faktiske)

31. oktober 2017

Datoer for studieregistrering

Først indsendt

2. oktober 2015

Først indsendt, der opfyldte QC-kriterier

5. oktober 2015

Først opslået (Skøn)

6. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2020

Sidst verificeret

1. maj 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A125548

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes mellitus

Kliniske forsøg med Testing and Monitoring of Blood Glucose Levels

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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CROs in Luxembourg

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner