Mind Your Heart Intervention for American Indian Women (MYH)
22 de junho de 2026 atualizado por: University of North Carolina, Chapel Hill
MIND Your Heart Study for American Indian Women
The goal of this clinical trial is to learn if a culturally-adapted intervention can improve cardiovascular health in American Indian women.
The main questions it aims to answer are:
- Can this intervention realistically work for American Indian women?
- Do American Indian women find the intervention acceptable?
- Does the intervention help improve cardiovascular health in American Indian women? Researchers will compare the intervention group to a control group (a group that does not receive the intervention) to see whether the cardiovascular health of the intervention group improves.
Participants will:
- Attend 3 data collections over 3 months.
- Be randomly assigned to either the intervention group or a control group.
- (Intervention group participants) attend 8 weekly classes.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
Conduct a 3-month randomized controlled pilot study to examine feasibility, acceptability, and initial efficacy of an 8-week, culturally-adapted intervention in American Indian women at risk for cardiovascular disease on the following outcomes:
Primary cardiovascular health outcomes:
- blood pressure
- heart rate variability
- inflammatory markers
- metabolic function
Secondary outcomes:
- stress
- positive psychological well-being
- health behaviors (diet, exercise)
- self-regulation
- self-efficacy
Tipo de estudo
Intervencional
Inscrição (Estimado)
70
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Jada Brooks
- Número de telefone: 919-966-4260
- E-mail: jada@email.unc.edu
Locais de estudo
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North Carolina
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Pembroke, North Carolina, Estados Unidos, 28372
- Recrutamento
- UNC Health Primary and Specialty Care at Pembroke
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Contato:
- Practice Manager
- Número de telefone: 910-775-9027
- E-mail: Paula.Mclean@unchealth.unc.edu
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Women 18-55 years old who self-identify as Lumbee Indian and
Have one or more risk factors for cardiovascular disease:
- overweight/obese, defined as BMI >25 kg/m^2
- hypertensive as measured by study staff
- physical inactivity
- Willing and able to follow study procedures
Exclusion Criteria:
- Women currently enrolled in an organized weight-loss or mindfulness program
- Pregnant women or women planning to become pregnant during the study period
Conditions that exclude study enrollment include:
- heart murmur
- congenital heart disease
- family history of sudden death
- or orthopedic limitations or health conditions precluding exercise
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention Group
Intervention Group: 8-week culturally-adapted intervention
|
A culturally-adapted cardiovascular health promotion intervention delivered for 8-weeks with American Indian women at risk for cardiovascular disease
|
|
Sem intervenção: Regular Care
Control Group: receives no intervention during the study
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Blood pressure
Prazo: Baseline, Week 8, and Month 3
|
Blood pressure will be measured three times during each appointment.
The first blood pressure will be discarded, and the second and third measures will be averaged.
Participants will rest 1 to 2 minutes between each reading.
|
Baseline, Week 8, and Month 3
|
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Change in Heart rate variability (HRV)
Prazo: Baseline and Month 3
|
HRV will be measured using a dual wireless electrocardiogram portable device for 10 minutes while the participant is resting in a seated position.
|
Baseline and Month 3
|
|
Change in Hs-CRP
Prazo: Baseline and Month 3
|
Collection of high-sensitivity C-reactive protein (Hs-CRP) to measure inflammation.
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Baseline and Month 3
|
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Change in Interleukin-6 (IL-6)
Prazo: Baseline and Month 3
|
Collection of IL-6 to measure inflammation.
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Baseline and Month 3
|
|
Change in Hemoglobin A1c
Prazo: Baseline and Month 3
|
Collection of hemoglobin A1c to measure metabolic function.
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Baseline and Month 3
|
|
Change in Lipid panel
Prazo: Baseline and Month 3
|
Collection of a fasting lipid panel to measure total cholesterol, high-density lipoprotein, triglycerides, and low-density lipoprotein to measure metabolic function.
|
Baseline and Month 3
|
|
Change in body mass index (BMI)
Prazo: Baseline, Week 8, and Month 3
|
Collection of weight and height to calculate BMI.
Weight and height will be collected two times during each visit and averaged.
The average weight and height will be calculated to determine BMI.
BMI is calculated as weight (kg) / height (m^2).
|
Baseline, Week 8, and Month 3
|
|
Change in body fat percentage
Prazo: Baseline, Week 8, and Month 3
|
Collection of body fat measurements using a handheld bioelectrical impedance device.
|
Baseline, Week 8, and Month 3
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in contextualized stress: burden
Prazo: Baseline, Week 8, and Month 3
|
The investigators will measure burden (as a subscale of contextualized stress) using the Jackson, Hogue, Phillips (JHP) Contextualized Stress Measure (Gendered and Financial Stress) Burden Subscale.
17-item subscale of the JHP Contextualized Stress measure assessing chronic exposure to gendered and racialized stress.
The burden subscale uses a 6-point Likert scale (1=Strongly Agree to 5=Strongly Disagree; 6=Not Applicable).
Scores range from 17-102 with higher scores reflect a better outcome.
|
Baseline, Week 8, and Month 3
|
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Change in perceived stress
Prazo: Baseline, Week 8, and Month 3
|
Perceived stress will be measured using the Perceived Stress Scale (PSS), a 10-item scale assessing stress experiences over the preceding month.
The PSS measures the frequency of feelings and thoughts using a 5-point Likert scale, where positive responses are scored in reverse.
The PSS score is determined by totaling all responses and ranges from 0 to 40 with lower scores reflecting a better outcome.
|
Baseline, Week 8, and Month 3
|
|
Change in positive psychological well-being
Prazo: Baseline, Week 8, and Month 3
|
Mental Health Continuum - Short Form (MHC-SF) measures positive emotions and comprises 14 items, representing emotional well-being, psychosocial well-being, and social well-being.
On a 6-point Likert scale (0 = never; 5 = everyday), respondents indicate how often they felt various positive feelings in the past month and the extent of their agreement or disagreement with various statements indicative of psychosocial and social well-being.
Possible scores for the MHC-SF range from 0 - 70.
Higher scores reflect a better outcome.
|
Baseline, Week 8, and Month 3
|
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Change in positive emotions
Prazo: Baseline, Week 8, and Month 3
|
The Modified Differential Emotions Scale (mDES) will be used to capture a broader array of emotions.
Respondents rate the frequency of their experiences of 20 different emotions over the past two weeks, using a 5-point scale (0 = not at all; 4 = most of the time).
Items are summed for both positive and negative emotions (both ranging from 0 - 40).
Higher scores on the positive subscale indicate more positive emotions.
|
Baseline, Week 8, and Month 3
|
|
Change in negative emotions
Prazo: Baseline, Week 8, and Month 3
|
The Modified Differential Emotions Scale (mDES) will be used to capture a broader array of emotions.
Respondents rate the frequency of their experiences of 20 different emotions over the past two weeks, using a 5-point scale (0 = not at all; 4 = most of the time).
Items are summed for both positive and negative emotions (both ranging from 0 - 40).
Higher scores on the negative subscale indicate more negative emotions.
|
Baseline, Week 8, and Month 3
|
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Change in carotenoid concentration
Prazo: Baseline, Week 8, and Month 3
|
As a proxy for fruit and vegetable (F/V) intake, carotenoid concentrations in the skin will be measured using a portable, non-invasive, pressure-mediated reflection spectroscopy device called the Veggie Meter.
The Veggie Meter produces a score from 0 to 800, with higher scores indicating greater skin carotenoid levels, which suggest a greater intake of fruits and vegetables.
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Baseline, Week 8, and Month 3
|
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Change in physical activity
Prazo: Baseline, Week 8, and Month 3
|
Physical activity will be measured by total time being active.
Investigators will collect activity data over a 7-day span using an accelerometer worn on the wrist.
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Baseline, Week 8, and Month 3
|
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Change in mindfulness self-regulation
Prazo: Baseline, Week 8, and Month 3
|
Mindfulness self-regulation will be measured using the Five Facet Mindfulness Questionnaire (FFMQ), a 39-item, self-administered measure that assesses various aspects of mindfulness.
Responses range from 1 (never/very rarely true) to 5 (almost always/always true) and are summed for a final score.
Higher scores indicate greater mindfulness.
Total scores range from 39 - 195.
|
Baseline, Week 8, and Month 3
|
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Change in eating self-efficacy
Prazo: Baseline, Week 8, and Month 3
|
Eating self-efficacy will be measured using the Eating Self-Efficacy Scale, a 25-item tool asking respondents to rate their difficulty in controlling eating from 1 (no difficulty) to 7 (most difficultly).
Scores range from 25 - 175 with higher total scores indicating lower self-efficacy.
|
Baseline, Week 8, and Month 3
|
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Change in exercise self-efficacy
Prazo: Baseline, Week 8, and Month 3
|
Exercise self-efficacy will be measured using the Self-Efficacy for Exercise Scale (SEE), which records the strength of efficacy beliefs by 9 questions on a 11-point scale from 0 (cannot do at all) to 10 (certain can do).
Scores range from 0 - 90 with higher scores indicating greater exercise self-efficacy.
|
Baseline, Week 8, and Month 3
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Change in contextualized stress: stress states
Prazo: Baseline, Week 8, and Month 3
|
The investigators will measure stress states (as a subscale of contextualized stress) using the Jackson, Hogue, Phillips (JHP) Contextualized Stress Measure (Gendered and Financial Stress) Stress States Subscale.
4-item subscale of the JHP Contextualized Stress assessing chronic exposure to gendered and racialized stress.
The stress states subscale uses a 6-point Likert scale (1=Strongly Agree to 5=Strongly Disagree; 6=Not Applicable).
Higher scores indicate greater stress.
|
Baseline, Week 8, and Month 3
|
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Change in Super Woman Schema (SWS)
Prazo: Baseline, Week 8, and Month 3
|
35-item measures 5 dimensions of internalized strength, emotion suppression, vulnerability resistance, motivation, and caretaking.
Items are summed using a Likert scale (0=not true to 4=true all the time).
Low SWS = 0-36; Moderate SWS = 36-70; High SWS = 71-105.
Higher scores indicate closer alignment to the schema.
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Baseline, Week 8, and Month 3
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jada Brooks, University of North Carolina, Chapel Hill
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
7 de abril de 2026
Conclusão Primária (Estimado)
1 de julho de 2026
Conclusão do estudo (Estimado)
1 de julho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
5 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de maio de 2026
Primeira postagem (Real)
12 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de junho de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 21-1762
- 5R34HL158947-03 (Concessão/Contrato do NIH dos EUA)
- 5R34HL158947-02 (Concessão/Contrato do NIH dos EUA)
- 1R34HL158947-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Deidentified individual data that supports the results will be shared beginning 9 and continuing for 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Prazo de Compartilhamento de IPD
beginning 9 and continuing for 24 months
Critérios de acesso de compartilhamento IPD
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .