Feeding America Intervention Trial for Health--Diabetes Mellitus (FAITH-DM)
14 maj 2020 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
568
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
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Oakland, California, Förenta staterna, 94614
- Alameda County Community Food Bank
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San Francisco, California, Förenta staterna, 94143
- University of California San Francisco
-
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Michigan
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Detroit, Michigan, Förenta staterna, 48207
- Gleaners Community Food Bank of Southeastern Michigan
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-
Texas
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Houston, Texas, Förenta staterna, 77029
- Houston Food Bank
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline HbA1c at 6 Months
Tidsram: 6 months
|
Point-of-care HbA1c testing with the PTS Diagnostics A1CNow®+ System
|
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline Dietary Intake
Tidsram: 6 months and 12 months
|
Brief fruit & vegetable dietary screener
|
6 months and 12 months
|
|
Change from Baseline Health Care Utilization
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 6 months and 12 months
|
Morisky Medication Adherence Scale (4 items)
|
6 months and 12 months
|
|
Food vs medicine trade-offs
Tidsram: 6 months and 12 months
|
Three self-reported questions
|
6 months and 12 months
|
|
Change from Baseline Food security status
Tidsram: 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
Tidsram: 6 months and 12 months
|
Two items assessing adequacy of food resources to last the entire month
|
6 months and 12 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline Diabetes Self-Efficacy
Tidsram: 6 months and 12 months
|
8-item scale of diabetes-specific self-efficacy
|
6 months and 12 months
|
|
Change from Baseline Diabetes Self-Care
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Hilary K Seligman, MD MAS, University of California, San Francisco
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 oktober 2015
Primärt slutförande (Faktisk)
31 oktober 2017
Avslutad studie (Faktisk)
31 oktober 2017
Studieregistreringsdatum
Först inskickad
2 oktober 2015
Först inskickad som uppfyllde QC-kriterierna
5 oktober 2015
Första postat (Uppskatta)
6 oktober 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 maj 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 maj 2020
Senast verifierad
1 maj 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- A125548
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