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Aha Oneida -undersøgelsen

3. november 2026 opdateret af: University of Wisconsin, Madison

Transformering af risikofaktorer i en indfødte amerikanske befolkning med høj slagtilfælde gennem et kulturelt ernæringsprogram

The purpose of this clinical trial is to learn whether a cultural nutritional program can change stroke risk factors, cognitive decline, and learn how school education programs about nutrition can improve health in the Oneida Nation.

Participants will undergo:

  • A carotid ultrasound
  • Cognitive testing
  • Health assessment
  • Blood work
  • Health wellness coaching

Participants can expect to be in the study for 1 year.

Studieoversigt

Detaljeret beskrivelse

The specific aims for this study are: 1) to determine if a cultural nutritional program across generations can change stroke risk factors in the Oneida Nation; 2) to determine if a cultural nutritional program across generations can change vascular cognitive decline in the Oneida Nation; and, 3) determine how structured culturally competent school education programs about nutrition influence knowledge of health. The intervention used is health wellness coaching. All individuals enrolled in this study will have opportunity to interact with an Oneida Nation employed Health wellness coach to find out about Oneida resources that they can use to modify their stroke risk factors.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

95

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53705
        • Rekruttering
        • University of Wisconsin - Madison
        • Ledende efterforsker:
          • Robert Dempsey, MD
        • Kontakt:
      • Oneida, Wisconsin, Forenede Stater, 54155
        • Rekruttering
        • Oneida Nation Reservation

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

7 år til 85 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 7-85 years
  • Receiving healthcare though the Oneida Comprehensive Health Division

Exclusion Criteria:

  • Not Native American

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: School-age Native Americans

Participants who are age 7-17 and live with adult parent or guardian will answer a 10 question nutritional knowledge questionnaire.

Health wellness coach will provide education and guidance about cultural nutrition

Participants will undergo an ultrasound

Educational program will teach students about healthy Native American food choices

Participants will undergo a cognitive test.

Eksperimentel: Adult Native Americans

Adults age 18-85

Health wellness coach will provide education and guidance about cultural nutrition

Participants will undergo an ultrasound

Participants will undergo a cognitive test.

Participants will undergo blood work.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring i viden om sundhed gennem en struktureret kulturelt kompetente skoleuddannelsesprogrammer om ernæring
Tidsramme: Baseline til 1 år
Baseline til 1 år
Change in incidence of stroke and transient ischemic attack (TIA)
Tidsramme: Baseline to 1 year

Number of incidences of stroke or TIA during the study

Baseline to 1 year
Change in number of participants that meet American Heart Association (AHA) Simple Rules for Diastolic Blood Pressure.
Tidsramme: Baseline to 1 year

The AHA's simple rules for diastolic blood pressure: Normal = Less than 80 mm Hg; Elevated = Less than 80 mm Hg with a systolic reading of 120-129 mm Hg; Stage 1 Hypertension = 80-89 mm Hg; Stage 2 Hypertension = 90 mm Hg or higher; Hypertensive Crisis = Higher than 120 mm Hg (along with a systolic reading higher than 180 mm Hg). Researchers will be reporting the change in number of participants with diastolic blood pressure <90 mmHg.

Baseline to 1 year
Change in number of participants that meet AHA's Simple Rules for Systolic Blood Pressure.
Tidsramme: Baseline to 1 year

The AHA uses these simple rules for systolic blood pressure (the top number): Normal is less than 120, Elevated is 120-129, Stage 1 Hypertension is 130-139, and Stage 2 Hypertension is 140 or higher. A systolic reading of 180 or higher indicates a hypertensive emergency. Researchers will be reporting the change in number of participants with systolic blood pressure <140 mmHg.

Baseline to 1 year
Change in number of participants that meet AHA Simple Rules for Body Mass Index (BMI)
Tidsramme: Baseline to 1 year

The AHA uses the following guidelines for Body Mass Index (BMI) in adults:

Underweight = Less than 18.5; Normal Weight = Between 18.5 and 24.9; Overweight = Between 25 and 29.9; and, Obesity = 30 or higher. Researchers will be reporting any improvement in BMI.

Baseline to 1 year
Change in Montreal Cognitive Assessment (MoCA)
Tidsramme: Baseline to 1 year

MoCA is scored out of a total of 30 points, with a score of 26 or above generally considered normal. The MoCA assesses various cognitive domains, including memory, visuospatial abilities, language, and executive functions. A lower score indicates potential cognitive impairment, with specific cutoffs for mild (19-23), moderate (10-18), and severe (0-9) impairment.

Baseline to 1 year
Change in NIH Toolbox Score
Tidsramme: Baseline to 1 year

NIH Toolbox Cognition Battery consists of tests of multiple constructs to asses for cognitive, sensory, motor and emotional function

Baseline to 1 year
Change in Native American Acculturation Scale (NAAS)
Tidsramme: Baseline to 1 year

NAAS is a 20-item questionnaire developed to assess the level of acculturation in Native Americans. It measures an individual's connection to both traditional Native American culture and mainstream American culture. Scores range from a low of 1, indicating low acculturation (or high Native American identity) to a high of 5, indicating high acculturation (or high mainstream American identity), with a score of 3 indicating "bicultural". The NAAS examines areas like identity, language, friendships, behaviors, attitudes, and generational/geographic background.

Baseline to 1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in nutrition knowledge
Tidsramme: Baseline to 1 year

Change in knowledge will be assessed with pre-test, 1 year post-test of each participant to assess improvement in nutritional knowledge and understanding of healthy food options tied to Oneida culture. This will be assessed through a 10-question multiple choice survey about good versus bad nutrition choices. Participants will select their choices, low score indicates poor nutritional knowledge and high score indicating better understanding for healthy nutrition

Baseline to 1 year
Change in plaque area
Tidsramme: Baseline to 1 year

Measured via carotid ultrasound.

Baseline to 1 year
Change in pulsatility index in carotid arteries
Tidsramme: Baseline to 1 year

Measured via carotid ultrasound. This index is a unitless measurement calculated: peak systolic velocity - end diastolic velocity, divided by the mean velocity, higher values are thought to represent increased resistance to blood flow.

Baseline to 1 year

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Robert Dempsey, MD, University of Wisconsin, Madison

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)

11. september 2025

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

12. august 2025

Først indsendt, der opfyldte QC-kriterier

22. august 2025

Først opslået (Faktiske)

24. august 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2025-1171
  • SMPH/NEURO SURG/NEURO SURG (Anden identifikator: UW Madison)
  • FA (Anden identifikator: UW Madison)
  • Protocol Version 10/23/26 (Anden identifikator: UW Madison)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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