Oneida Nation MembersNCT07139132
The AHA Oneida Study
A study testing Health Wellness Coaching, Carotid ultrasound and School-age nutritional education program in people with Oneida Nation Members, run by University of Wisconsin, Madison at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Oneida Nation Members
- What is being tested?
- Health Wellness Coaching, Carotid ultrasound and School-age nutritional education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 7-85 years
- Receiving healthcare though the Oneida Comprehensive Health Division
Who cannot join
- Not Native American
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53705
Stephanie Wilbrand, PhD, 608-265-9248, wilbrand@neurosurgery.wisc.edu
Robert Dempsey, MD
- Recruiting
Oneida Nation Reservation
Oneida, Wisconsin, 54155
About this study
Official title: 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.
Read the 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.
- Conditions
- Oneida Nation Members
- Being tested
- Health Wellness Coaching, Carotid ultrasound, School-age nutritional education program, Cognitive Testing, Blood work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Wellness CoachingBehavioural
Health wellness coach will provide education and guidance about cultural nutrition
Carotid ultrasoundDiagnostic test
Participants will undergo an ultrasound
School-age nutritional education programBehavioural
Educational program will teach students about healthy Native American food choices
Cognitive TestingDiagnostic test
Participants will undergo a cognitive test.
Blood workDiagnostic test
Participants will undergo blood work.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Health Wellness Coaching; Diagnostic Test: Carotid ultrasound; Diagnostic Test: Cognitive Testing; Diagnostic Test: Blood work |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in incidence of stroke and transient ischemic attack (TIA)
Number of incidences of stroke or TIA during the study
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline to 1 year
Change in knowledge of health through a structured culturally competent school education programs about nutrition
Measured: Baseline to 1 year
Secondary outcomes (3)
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
Measured: Baseline to 1 year
Change in plaque area
Measured via carotid ultrasound.
Measured: 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.
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start11 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oneida Nation MembersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Robert Dempsey, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139132
- Sponsor's protocol ID
- 2025-1171
- Other IDs
- SMPH/NEURO SURG/NEURO SURG, FA, Protocol Version 7/21/26
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Risk Factors in a High Stroke Risk Native American Population Through a Cultural Nutritional Program
- ClinicalTrials.gov ID
- NCT07139132
- Acronym / sponsor ID
- 2025-1171
- Conditions
- Oneida Nation Members
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School-age Native Americans | Experimental | Behavioral: Health Wellness Coaching, Diagnostic Test: Carotid ultrasound, Behavioral: School-age nutritional education program, Diagnostic Test: Cognitive TestingParticipants who are age 7-17 and live with adult parent or guardian will answer a 10 question nutritional knowledge questionnaire. |
| Adult Native Americans | Experimental | Behavioral: Health Wellness Coaching, Diagnostic Test: Carotid ultrasound, Diagnostic Test: Cognitive Testing, Diagnostic Test: Blood workAdults age 18-85 |
Who may qualify
- Ages
- 7 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age 7-85 years
- Receiving healthcare though the Oneida Comprehensive Health Division
Key exclusion criteria (1 listed)
- Not Native American
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Wellness CoachingHealth wellness coach will provide education and guidance about cultural nutrition | Behavioural | Adult Native Americans, School-age Native Americans |
| Carotid ultrasoundParticipants will undergo an ultrasound | Diagnostic test | Adult Native Americans, School-age Native Americans |
| School-age nutritional education programEducational program will teach students about healthy Native American food choices | Behavioural | School-age Native Americans |
| Cognitive TestingParticipants will undergo a cognitive test. | Diagnostic test | Adult Native Americans, School-age Native Americans |
| Blood workParticipants will undergo blood work. | Diagnostic test | Adult Native Americans |
Primary outcome
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
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.
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.
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.
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.
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
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.
Change in knowledge of health through a structured culturally competent school education programs about nutrition
Time frame: Baseline to 1 year
3 secondary outcomes
Change in nutrition knowledge
Time frame: Baseline to 1 year
Change in plaque area
Time frame: Baseline to 1 year
Change in pulsatility index in carotid arteries
Time frame: Baseline to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Dempsey, MD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Wellness Coaching, Carotid ultrasound and School-age nutritional education program in people with Oneida Nation Members, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Wilbrand, PhD (608-265-9248, wilbrand@neurosurgery.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in incidence of stroke and transient ischemic attack (TIA) (time frame: Baseline to 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.