Recruiting

Nutritional Program

Sponsor:

University of Wisconsin, Madison

Code:

NCT07139132

Conditions

Oneida Nation Members

Eligibility Criteria

Sex: All

Age: 7 - 70+

Healthy Volunteers: Accepted

Interventions

Health Wellness Coaching

Carotid ultrasound

School-age nutritional education program

Cognitive Testing

Blood work

Study Details

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

Study ID

NCT07139132

Start date

Sep 11, 2025

Status verified date

Jul, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Not Native American

Study Design

Enrollment

95 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

experimental: Adult Native Americans

Adults age 18-85

Interventions

Health Wellness Coaching

Health wellness coach will provide education and guidance about cultural nutrition

Carotid ultrasound

Participants will undergo an ultrasound

School-age nutritional education program

Educational program will teach students about healthy Native American food choices

Cognitive Testing

Participants will undergo a cognitive test.

Blood work

Participants will undergo blood work.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Stephanie Wilbrand, PhD

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

Locations

University of Wisconsin - Madison

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Stephanie Wilbrand, PhD

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

Principal Investigator:

Robert Dempsey, MD

Oneida Nation Reservation

Recruiting

Oneida, Wisconsin, United States, 54155

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-07-29.