Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-22 @ 5:24 PM
Study NCT ID:
NCT07139132
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The AHA Oneida Study
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Transforming Risk Factors in a High Stroke Risk Native American Population Through a Cultural Nutritional Program
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: