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Diabetes Prevention for Black Men

10. juni 2021 opdateret af: NYU Langone Health

Using a Geographically Targeted and Mixed Methods Approach to Improve Glycemic Control Among Black Men Identified as Having Previously Undiagnosed Diabetes and Prediabetes

Geographic analyses of diabetes burden have found that poor glycemic control, high rates of diabetes-related hospital utilization, and a high prevalence of microvascular diabetic complications all cluster in the same neighborhoods.This proposed study seeks to identify Black barbers with undiagnosed diabetes or prediabetes using point-of-care HbA1c testing, perform qualitative interviews to identify health behaviors that may explain poor sugar control, and develop a workplace-based food intervention to promote primary prevention and test its effect on sugar control in these individuals.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

16

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
    • New York
      • New York, New York, Forenede Stater, 10016
        • New York University School of Medicine

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

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Black or African American men who work as barbers at Black-owned barbershops
  • Barbershop clients.
  • Workplace in neighborhood geographically identified as having higher diabetes burden
  • No prior history of clinical diagnosis of diabetes
  • Identified on initial and second point-of-care testing to have an HbA1c of 5.7 or greater

Exclusion Criteria:

  • Individuals with a history of blood loss or blood disorder that would lead to incorrect results on point-of care HbA1c testing
  • Individuals with a history of food allergies that requires specific dietary restrictions
  • Individuals who are not English speaking
  • Individuals who have a significant cognitive impairment that will be a barrier to communication, valid consent and participation

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dietary intervention
Community-based dietary intervention to Black and African American barbers identified as having previously undiagnosed diabetes and prediabetes
Adfærdsmæssigt: Dietary intervention
Over a 60-day period, participants will receive healthy lunches that provide a hand-delivered healthy alterative to their current diets.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adherence to the intervention during the initial 60-day period when lunches are provided at no cost
Tidsramme: 60 days
Adherence will be calculated as the proportion of participants continuing to consume at least 80% of the lunch meals at the end of the initial intervention period when lunches will be provided at no cost.
60 days
Continuation with the dietary intervention after initial period when study participants may choose to pay for meals developed on their own
Tidsramme: Until the end of the two year study period
proportion of participants continue to purchase meals after the initial intervention period when individuals will be given the option to continue the intervention but paying for the lunch meals themselves.
Until the end of the two year study period

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Photographic food and beverage diaries
Tidsramme: Baseline
Study participants will take photos of all food and beverages ingested over a 72-hourperiod to provide quantitative data on baseline dietary patterns
Baseline
First Point-of-care Hemoglobin A1c (HbA1c) test
Tidsramme: Baseline
This first baseline point-of-care HbA1c test will be used as a reference.
Baseline
Second Point-of-care HbA1C test
Tidsramme: Baseline (3-6 months after first test)
This second baseline point-of-care HbA1c test will be used to identify any changes in glycemic control that developed after initial diagnosis of diabetes or prediabetes by the first point-of-care test.
Baseline (3-6 months after first test)
Third Point-of-care HbA1C test
Tidsramme: Post treatment (3 months after the intervention)
This post-treatment HbA1c test will be used to identify whether there was any short-term change in glycemic control after the dietary intervention
Post treatment (3 months after the intervention)
Fourth Point-of-Care HbA1c Test
Tidsramme: Post-Treatment (6 to 12 months after the intervention)
This post-treatment HbA1c test will be used to identify whether there was any longer-term change in glycemic control after the dietary intervention
Post-Treatment (6 to 12 months after the intervention)

Samarbejdspartnere og efterforskere

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

Sponsor

NYU Langone Health

Efterforskere

  • Ledende efterforsker: David Lee, MD, NYU Langone Health

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)

25. marts 2019

Primær færdiggørelse (Faktiske)

23. juni 2020

Studieafslutning (Faktiske)

23. juni 2020

Datoer for studieregistrering

Først indsendt

14. september 2018

Først indsendt, der opfyldte QC-kriterier

12. oktober 2018

Først opslået (Faktiske)

17. oktober 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 18-00826
  • R03DK120895 (Andet bevillings-/finansieringsnummer: NIH-NIDDK)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.

IPD-delingstidsramme

Beginning 3 months and ending 5 years following article publication.

IPD-delingsadgangskriterier

Researchers who provide a methodologically sound proposal will have access to the data. Requests should be directed to david.lee@nyumc.org. To gain access, data requestors will need to sign a data access agreement.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

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