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NCT Number: NCT07139132

The AHA Oneida Study

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.

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Key information

Age range

7 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin - Madison, Madison, Wisconsin, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not Native American

Treatment and study plan

Health Wellness Coaching

Behavioral

Health wellness coach will provide education and guidance about cultural nutrition

Carotid ultrasound

Diagnostic Test

Participants will undergo an ultrasound

School-age nutritional education program

Behavioral

Educational program will teach students about healthy Native American food choices

Cognitive Testing

Diagnostic Test

Participants will undergo a cognitive test.

blood work

Diagnostic Test

Participants will undergo blood work.

Primary outcomes

  1. Change in incidence of stroke and transient ischemic attack (TIA)

    Time frame: Baseline to 1 year

    Number of incidences of stroke or TIA during the study

  2. Change in number of participants that meet American Heart Association (AHA) Simple Rules for Diastolic Blood Pressure.

    Time frame: 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.

  3. Change in number of participants that meet AHA's Simple Rules for Systolic Blood Pressure.

    Time frame: 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.

  4. Change in number of participants that meet AHA Simple Rules for Body Mass Index (BMI)

    Time frame: 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.

  5. Change in Montreal Cognitive Assessment (MoCA)

    Time frame: 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.

  6. Change in NIH Toolbox Score

    Time frame: Baseline to 1 year

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

  7. Change in Native American Acculturation Scale (NAAS)

    Time frame: 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.

  8. Change in knowledge of health through a structured culturally competent school education programs about nutrition

    Time frame: Baseline to 1 year

Secondary outcomes

  1. Change in nutrition knowledge

    Time frame: 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

  2. Change in plaque area

    Time frame: Baseline to 1 year

    Measured via carotid ultrasound.

  3. Change in pulsatility index in carotid arteries

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Wilbrand, PhD

CONTACT

[email protected]

608-265-9248

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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