- ICH GCP
- 米国臨床試験登録
- 臨床試験 NCT07139132
- オリジナルトライアル
Aha oneida研究
文化的栄養プログラムを通じて、脳卒中リスクの高いリスクのリスクの変換ネイティブアメリカンの人口
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Stephanie Wilbrand, PhD
- 電話番号:608-265-9248
- メール:wilbrand@neurosurgery.wisc.edu
研究場所
-
-
Wisconsin
-
Madison、Wisconsin、アメリカ、53705
- 募集
- University of Wisconsin - Madison
-
主任研究者:
- Robert Dempsey, MD
-
コンタクト:
- Stephanie Wilbrand, PhD
- 電話番号:608-265-9248
- メール:wilbrand@neurosurgery.wisc.edu
-
Oneida、Wisconsin、アメリカ、54155
- 募集
- Oneida Nation Reservation
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 7-85 years
- Receiving healthcare though the Oneida Comprehensive Health Division
Exclusion Criteria:
- Not Native American
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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. |
Health wellness coach will provide education and guidance about cultural nutrition Participants will undergo an ultrasound Educational program will teach students about healthy Native American food choices Participants will undergo a cognitive test. |
|
実験的:Adult Native Americans
Adults age 18-85 |
Health wellness coach will provide education and guidance about cultural nutrition Participants will undergo an ultrasound Participants will undergo a cognitive test. Participants will undergo blood work. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
栄養に関する構造化された文化的に有能な学校教育プログラムを通じて健康に関する知識の変化
時間枠:ベースラインから1年
|
ベースラインから1年
|
|
|
Change in incidence of stroke and transient ischemic attack (TIA)
時間枠:Baseline to 1 year
|
Number of incidences of stroke or TIA during the study |
Baseline to 1 year
|
|
Change in number of participants that meet American Heart Association (AHA) Simple Rules for Diastolic Blood Pressure.
時間枠: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. |
Baseline to 1 year
|
|
Change in number of participants that meet AHA's Simple Rules for Systolic Blood Pressure.
時間枠: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. |
Baseline to 1 year
|
|
Change in number of participants that meet AHA Simple Rules for Body Mass Index (BMI)
時間枠: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. |
Baseline to 1 year
|
|
Change in Montreal Cognitive Assessment (MoCA)
時間枠: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. |
Baseline to 1 year
|
|
Change in NIH Toolbox Score
時間枠:Baseline to 1 year
|
NIH Toolbox Cognition Battery consists of tests of multiple constructs to asses for cognitive, sensory, motor and emotional function |
Baseline to 1 year
|
|
Change in Native American Acculturation Scale (NAAS)
時間枠: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. |
Baseline to 1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in nutrition knowledge
時間枠:Baseline to 1 year
|
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 |
Baseline to 1 year
|
|
Change in plaque area
時間枠:Baseline to 1 year
|
Measured via carotid ultrasound. |
Baseline to 1 year
|
|
Change in pulsatility index in carotid arteries
時間枠:Baseline to 1 year
|
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. |
Baseline to 1 year
|
協力者と研究者
捜査官
- 主任研究者:Robert Dempsey, MD、University of Wisconsin, Madison
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2025-1171
- SMPH/NEURO SURG/NEURO SURG (その他の識別子:UW Madison)
- FA (その他の識別子:UW Madison)
- Protocol Version 10/23/26 (その他の識別子:UW Madison)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。