The AHA Oneida Study

NCT ID: NCT07139132

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-11

Study Completion Date

2027-09-30

Brief Summary

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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

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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.

Conditions

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Oneida Nation Members

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Health Wellness Coaching

Intervention Type BEHAVIORAL

Health wellness coach will provide education and guidance about cultural nutrition

Carotid ultrasound

Intervention Type DIAGNOSTIC_TEST

Participants will undergo an ultrasound

School-age nutritional education program

Intervention Type BEHAVIORAL

Educational program will teach students about healthy Native American food choices

Cognitive Testing

Intervention Type DIAGNOSTIC_TEST

Participants will undergo a cognitive test.

Adult Native Americans

Adults age 18-85

Group Type EXPERIMENTAL

Health Wellness Coaching

Intervention Type BEHAVIORAL

Health wellness coach will provide education and guidance about cultural nutrition

Carotid ultrasound

Intervention Type DIAGNOSTIC_TEST

Participants will undergo an ultrasound

Cognitive Testing

Intervention Type DIAGNOSTIC_TEST

Participants will undergo a cognitive test.

Blood work

Intervention Type DIAGNOSTIC_TEST

Participants will undergo blood work.

Interventions

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Health Wellness Coaching

Health wellness coach will provide education and guidance about cultural nutrition

Intervention Type BEHAVIORAL

Carotid ultrasound

Participants will undergo an ultrasound

Intervention Type DIAGNOSTIC_TEST

School-age nutritional education program

Educational program will teach students about healthy Native American food choices

Intervention Type BEHAVIORAL

Cognitive Testing

Participants will undergo a cognitive test.

Intervention Type DIAGNOSTIC_TEST

Blood work

Participants will undergo blood work.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not Native American
Minimum Eligible Age

7 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Heart Association (AHA)

UNKNOWN

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Dempsey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin - Madison

Madison, Wisconsin, United States

Site Status RECRUITING

Oneida Nation Reservation

Oneida, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stephanie Wilbrand, PhD

Role: CONTACT

608-265-9248

Facility Contacts

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Stephanie Wilbrand, PhD

Role: primary

608-265-9248

Other Identifiers

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SMPH/NEURO SURG/NEURO SURG

Identifier Type: OTHER

Identifier Source: secondary_id

FA

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 10/2/25

Identifier Type: OTHER

Identifier Source: secondary_id

2025-1171

Identifier Type: -

Identifier Source: org_study_id

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