Feeding America Intervention Trial for Health--Diabetes Mellitus (FAITH-DM)
14. mai 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
568
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
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Oakland, California, Forente stater, 94614
- Alameda County Community Food Bank
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San Francisco, California, Forente stater, 94143
- University of California San Francisco
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Michigan
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Detroit, Michigan, Forente stater, 48207
- Gleaners Community Food Bank of Southeastern Michigan
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Texas
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Houston, Texas, Forente stater, 77029
- Houston Food Bank
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Immediate Intervention
Participants randomized to the Intervention Arm will immediately begin a four-component intervention.
|
Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals
Referral to a local primary care provider, if none currently exists.
Coordination of care with primary care provider.
Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.
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.
|
Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals
Referral to a local primary care provider, if none currently exists.
Coordination of care with primary care provider.
Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Hilary K Seligman, MD MAS, University of California, San Francisco
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. oktober 2015
Primær fullføring (Faktiske)
31. oktober 2017
Studiet fullført (Faktiske)
31. oktober 2017
Datoer for studieregistrering
Først innsendt
2. oktober 2015
Først innsendt som oppfylte QC-kriteriene
5. oktober 2015
Først lagt ut (Anslag)
6. oktober 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. mai 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. mai 2020
Sist bekreftet
1. mai 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- A125548
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