Cultural Nutrition Program for Stroke and Cognitive Decline Risk in Native Americans

Recruiting at 1 trial location

Overseen By Stephanie Wilbrand, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Not Native American

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

85 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a cultural nutrition program can reduce stroke risks and prevent cognitive decline among Native Americans. Participants will receive health coaching and participate in a school-age nutritional education program. The study includes tests such as a carotid ultrasound, cognitive assessments, and blood work. It targets Native Americans aged 7-85 who receive healthcare from the Oneida Comprehensive Health Division. Participants will engage in the study for about a year. As an unphased trial, this study provides a unique opportunity to contribute to culturally tailored health solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this cultural nutritional program is safe?

Research has shown that the school-age nutritional education program is well-received by Native American participants, with no major side effects reported. This program educates young people on healthy eating habits, aiding them in making better food choices throughout their lives. Such education has proven effective in developing healthier eating patterns.

Regarding health wellness coaching, studies suggest it safely reduces stroke risk factors. The coaching helps individuals understand and manage their health more effectively. No evidence of serious negative effects has been found from this approach in similar settings. Overall, these programs emphasize education and lifestyle changes, which are generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cultural Nutrition Program because it focuses on education to reduce stroke and cognitive decline risk, specifically in Native American communities. Unlike standard treatments that often rely on medications or lifestyle changes after a health issue is identified, this program proactively targets younger generations with nutritional knowledge, potentially preventing issues before they arise. By involving both school-age children and adults, the program aims to create a supportive, health-conscious community, fostering long-term habits that could lead to significant health improvements across generations.

What evidence suggests that this cultural nutrition program is effective for reducing stroke and cognitive decline risk in Native Americans?

Research has shown that cultural nutrition programs can improve health in Native American communities, particularly regarding stroke risk and memory problems. Studies have found that emphasizing traditional Native foods and reducing sugary drinks leads to better health outcomes. This trial will evaluate two approaches: a school-age nutritional education program and health wellness coaching. The school-age nutritional education program educates young Native Americans about nutrition, while health wellness coaching informs communities about stroke risk. Both methods address specific health issues faced by Native American populations, potentially lowering stroke rates and enhancing brain health. ^{1 2 3 4 6}

Who Is on the Research Team?

Robert Dempsey, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for Native Americans, specifically from the Oneida Nation. It's designed to see if a cultural nutritional program and school education can improve health outcomes related to stroke risk and cognitive decline.

Inclusion Criteria

Receiving healthcare through the Oneida Comprehensive Health Division

I am between 7 and 85 years old.

Exclusion Criteria

Not Native American

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo carotid ultrasound, cognitive testing, health assessment, and blood work

1-2 weeks

1 visit (in-person)

Intervention

Participants receive health wellness coaching and participate in a cultural nutritional program

12 months

Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for changes in stroke risk factors, cognitive decline, and nutritional knowledge

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Health Wellness Coaching
• School-age nutritional education program

Trial Overview Participants will receive health wellness coaching and take part in a school-age nutritional education program. They'll also undergo cognitive testing, blood work, and carotid ultrasound to monitor changes over the course of one year.

How Is the Trial Designed?

Group I: School-age Native Americans Experimental Treatment 4 Interventions

Participants who are age 7-17 and live with adult parent or guardian will answer a 10 question nutritional knowledge questionnaire.

Group II: Adult Native Americans Experimental Treatment 4 Interventions

Adults age 18-85

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

American Heart Association (AHA)

Collaborator

Trials

2

Recruited

530+

Citations

1. karger.com karger.com/ned/article/58/4/300/894858/Methods-in-Stroke-Prevention-in-the-Wisconsin

Methods in Stroke Prevention in the Wisconsin Native ... The aim of this study was to determine stroke risk factors that are most prevalent in Wisconsin Native Americans and to examine how education at ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38295773/

Methods in Stroke Prevention in the Wisconsin Native ... The aim of this study was to determine stroke risk factors that are most prevalent in Wisconsin Native Americans and to examine how education at the community ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04382963

Stroke Prevention in the Wisconsin Native American ... Intention to treat analysis will estimate the efficacy of health coaching ... Vascular cognitive decline is a risk factor for stroke, but also is modifiable.

4. wpp.med.wisc.edu wpp.med.wisc.edu/funded-project/stroke-prevention-native-american-population/

Stroke Prevention in the Wisconsin Native American Population Stroke is the fifth leading cause of death in Native Americans, and stroke incidence is 14 percent higher in this population than in other ...

5. researchgate.net researchgate.net/publication/377859811_Methods_in_'Stroke_Prevention_in_the_Wisconsin_Native_American_Population'

Methods in 'Stroke Prevention in the Wisconsin Native ... The aim of this study is to determine stroke risk factors that are most prevalent in Wisconsin Native Americans and to examine how education at the community ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/brb3.2671

Exploring facilitators and barriers to long‐term behavior ... This study aimed to explore the experiences of people at risk of stroke after receiving HWC for stroke prevention, specifically the facilitators and barriers ...