The AHA Oneida Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Oneida Nation Members
• Intervention / Treatment: Diagnostic test: Carotid ultrasound; Behavioral: Health Wellness Coaching; Behavioral: School-age nutritional education program; Diagnostic test: Cognitive Testing; Diagnostic test: Blood work

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.

• Study Type: Interventional
• Enrollment (Estimated): 95
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Wilbrand, PhD; Phone Number: 608-265-9248; Email: wilbrand@neurosurgery.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin - Madison
      • Principal Investigator: Robert Dempsey, MD
      • Contact: Stephanie Wilbrand, PhD; Phone Number: 608-265-9248; Email: wilbrand@neurosurgery.wisc.edu
    • Oneida, Wisconsin, United States, 54155
      • Recruiting
      • Oneida Nation Reservation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Not Native American

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: Carotid ultrasound; Participants will undergo an ultrasound; Behavioral: Health Wellness Coaching; Health wellness coach will provide education and guidance about cultural nutrition; 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.
Experimental: Adult Native Americans; Adults age 18-85	Diagnostic test: Carotid ultrasound; Participants will undergo an ultrasound; Behavioral: Health Wellness Coaching; Health wellness coach will provide education and guidance about cultural nutrition; Diagnostic test: Cognitive Testing; Participants will undergo a cognitive test.; Diagnostic test: Blood work; Participants will undergo blood work.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in plaque area	Measured via carotid ultrasound.	Baseline to 1 year
Change in pulsatility index in carotid arteries	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
Change in nutrition knowledge	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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Robert Dempsey, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: August 12, 2025
• First Submitted That Met QC Criteria: August 22, 2025
• First Posted (Actual): August 24, 2025

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography; Ultrasonography, Carotid Arteries
• Other Study ID Numbers: 2025-1171; SMPH/NEURO SURG/NEURO SURG (Other Identifier: UW Madison); FA (Other Identifier: UW Madison); Protocol Version 7/21/26 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No