跳至主要内容
临床试验/NCT07139132
NCT07139132招募中不适用

Transforming Risk Factors in a High Stroke Risk Native American Population Through a Cultural Nutritional Program

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2025年9月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
95
试验地点
2
主要终点
Change in incidence of stroke and transient ischemic attack (TIA)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
7 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •Not Native American

研究组 & 干预措施

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.

干预措施: Carotid ultrasound (Diagnostic Test)

Adult Native Americans

Experimental

Adults age 18-85

干预措施: Health Wellness Coaching (Behavioral)

Adult Native Americans

Experimental

Adults age 18-85

干预措施: Carotid ultrasound (Diagnostic Test)

Adult Native Americans

Experimental

Adults age 18-85

干预措施: Cognitive Testing (Diagnostic Test)

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.

干预措施: School-age nutritional education program (Behavioral)

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.

干预措施: Cognitive Testing (Diagnostic Test)

Adult Native Americans

Experimental

Adults age 18-85

干预措施: Blood work (Diagnostic Test)

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.

干预措施: Health Wellness Coaching (Behavioral)

结局指标

主要结局

Change in incidence of stroke and transient ischemic attack (TIA)

时间窗: 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.

时间窗: 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.

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: Baseline to 1 year

次要结局

  • Change in nutrition knowledge(Baseline to 1 year)
  • Change in plaque area(Baseline to 1 year)
  • Change in pulsatility index in carotid arteries(Baseline to 1 year)
  • Change in nutrition knowledge(Baseline to 1 year)
  • Change in plaque area(Baseline to 1 year)
  • Change in pulsatility index in carotid arteries(Baseline to 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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