O estudo AHA ONIDA
Transformando fatores de risco em um alto risco de riscos na população nativa americana por meio de um programa nutricional cultural
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Stephanie Wilbrand, PhD
- Número de telefone: 608-265-9248
- E-mail: wilbrand@neurosurgery.wisc.edu
Locais de estudo
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-
Wisconsin
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Madison, Wisconsin, Estados Unidos, 53705
- Recrutamento
- University of Wisconsin - Madison
-
Investigador principal:
- Robert Dempsey, MD
-
Contato:
- Stephanie Wilbrand, PhD
- Número de telefone: 608-265-9248
- E-mail: wilbrand@neurosurgery.wisc.edu
-
Oneida, Wisconsin, Estados Unidos, 54155
- Recrutamento
- Oneida Nation Reservation
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age 7-85 years
- Receiving healthcare though the Oneida Comprehensive Health Division
Exclusion Criteria:
- Not Native American
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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. |
|
Experimental: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mudança no conhecimento da saúde por meio de programas de educação escolar culturalmente competente estruturada sobre nutrição
Prazo: Linha de base para 1 ano
|
Linha de base para 1 ano
|
|
|
Change in incidence of stroke and transient ischemic attack (TIA)
Prazo: 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.
Prazo: 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.
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in nutrition knowledge
Prazo: 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
Prazo: Baseline to 1 year
|
Measured via carotid ultrasound. |
Baseline to 1 year
|
|
Change in pulsatility index in carotid arteries
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Robert Dempsey, MD, University of Wisconsin, Madison
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025-1171
- SMPH/NEURO SURG/NEURO SURG (Outro identificador: UW Madison)
- FA (Outro identificador: UW Madison)
- Protocol Version 10/23/26 (Outro identificador: UW Madison)
Plano para dados de participantes individuais (IPD)
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