The AHA Oneida Study

NCT07139132 | Recruiting DMC

• 4 other identifiers: 2025-1171SMPH/NEURO SURG/NEURO SURGFAProtocol Version 10/2/25
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Oneida Nation Members

Outcome Measures

Primary Outcomes (8)

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

  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.

  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.

  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)

  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)

  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

  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)

  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

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

  Baseline to 1 year

Secondary Outcomes (3)

• Change in nutrition knowledge

  Baseline to 1 year

• Change in plaque area

  Baseline to 1 year

• Change in pulsatility index in carotid arteries

  Baseline to 1 year

Study Arms (2)

School-age Native Americans

EXPERIMENTAL

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

Behavioral: Health Wellness Coaching; Diagnostic Test: Carotid ultrasound; Behavioral: School-age nutritional education program; Diagnostic Test: Cognitive Testing

Adult Native Americans

EXPERIMENTAL

Adults age 18-85

Behavioral: Health Wellness Coaching; Diagnostic Test: Carotid ultrasound; Diagnostic Test: Cognitive Testing; Diagnostic Test: Blood work

Interventions

Health Wellness Coaching BEHAVIORAL

Health wellness coach will provide education and guidance about cultural nutrition

Adult Native Americans; School-age Native Americans

Carotid ultrasound DIAGNOSTIC_TEST

Participants will undergo an ultrasound

Adult Native Americans; School-age Native Americans

School-age nutritional education program BEHAVIORAL

Educational program will teach students about healthy Native American food choices

School-age Native Americans

Cognitive Testing DIAGNOSTIC_TEST

Participants will undergo a cognitive test.

Adult Native Americans; School-age Native Americans

Blood work DIAGNOSTIC_TEST

Participants will undergo blood work.

Adult Native Americans

Eligibility Criteria

• Age: 7 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not Native American

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• American Heart Association (AHA): collaborator

Study Sites (2)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

RECRUITING

Oneida Nation Reservation

Oneida, Wisconsin, 54155, United States

RECRUITING

MeSH Terms

Interventions

Ultrasonography, Carotid Arteries

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Robert Dempsey, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Wilbrand, PhD

CONTACT

608-265-9248; wilbrand@neurosurgery.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 24, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (2)