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Recruiting NCT07139132

The AHA Oneida Study

No phase Interventional Oneida Nation Members

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health Wellness Coaching, Carotid ultrasound, School-age nutritional education program, Cognitive Testing.
Who it may be relevant to
Registry conditions: Oneida Nation Members. Basic parameters: 7 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Transforming Risk Factors in a High Stroke Risk Native American Population Through a Cultural Nutritional Program

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Health Wellness Coaching
    Health wellness coach will provide education and guidance about cultural nutrition
  • Diagnostic test Carotid ultrasound
    Participants will undergo an ultrasound
  • Behavioral School-age nutritional education program
    Educational program will teach students about healthy Native American food choices
  • Diagnostic test Cognitive Testing
    Participants will undergo a cognitive test.
  • Diagnostic test Blood work
    Participants will undergo blood work.

Primary outcome measures

  • Change in incidence of stroke and transient ischemic attack (TIA) [Time frame: Baseline to 1 year]
  • Change in number of participants that meet American Heart Association (AHA) Simple Rules for Diastolic Blood Pressure. [Time frame: Baseline to 1 year]
  • Change in number of participants that meet AHA's Simple Rules for Systolic Blood Pressure. [Time frame: Baseline to 1 year]
  • Change in number of participants that meet AHA Simple Rules for Body Mass Index (BMI) [Time frame: Baseline to 1 year]
  • Change in Montreal Cognitive Assessment (MoCA) [Time frame: Baseline to 1 year]
  • Change in NIH Toolbox Score [Time frame: Baseline to 1 year]
  • Change in Native American Acculturation Scale (NAAS) [Time frame: Baseline to 1 year]
  • Change in knowledge of health through a structured culturally competent school education programs about nutrition [Time frame: Baseline to 1 year]
Secondary outcome measures (3)
  • Change in nutrition knowledge [Time frame: Baseline to 1 year]
  • Change in plaque area [Time frame: Baseline to 1 year]
  • Change in pulsatility index in carotid arteries [Time frame: Baseline to 1 year]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Not Native American

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 2 centers
  • University of Wisconsin - Madison — Madison
  • Oneida Nation Reservation — Oneida

Identifiers

NCT: NCT07139132 · 2025-1171 · SMPH/NEURO SURG/NEURO SURG · FA · Protocol Version 7/21/26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗