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Mind Your Heart Intervention for American Indian Women (MYH)

2026年6月22日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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

研究类型

介入性

注册 (估计的)

70

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • North Carolina
      • Pembroke、North Carolina、美国、28372
        • 招聘中
        • UNC Health Primary and Specialty Care at Pembroke
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Intervention Group
Intervention Group: 8-week culturally-adapted intervention
行为的：Culturally-adapted intervention to improve cardiovascular health in American Indian women
A culturally-adapted cardiovascular health promotion intervention delivered for 8-weeks with American Indian women at risk for cardiovascular disease
无干预：Regular Care
Control Group: receives no intervention during the study

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Blood pressure
大体时间：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
Change in Heart rate variability (HRV)
大体时间：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
大体时间：Baseline and Month 3
Collection of high-sensitivity C-reactive protein (Hs-CRP) to measure inflammation.
Baseline and Month 3
Change in Interleukin-6 (IL-6)
大体时间：Baseline and Month 3
Collection of IL-6 to measure inflammation.
Baseline and Month 3
Change in Hemoglobin A1c
大体时间：Baseline and Month 3
Collection of hemoglobin A1c to measure metabolic function.
Baseline and Month 3
Change in Lipid panel
大体时间：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)
大体时间：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
大体时间：Baseline, Week 8, and Month 3
Collection of body fat measurements using a handheld bioelectrical impedance device.
Baseline, Week 8, and Month 3

次要结果测量

结果测量
措施说明
大体时间
Change in contextualized stress: burden
大体时间：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
Change in perceived stress
大体时间：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
大体时间：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
Change in positive emotions
大体时间：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
大体时间：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
Change in carotenoid concentration
大体时间：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.
Baseline, Week 8, and Month 3
Change in physical activity
大体时间：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.
Baseline, Week 8, and Month 3
Change in mindfulness self-regulation
大体时间：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
Change in eating self-efficacy
大体时间：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
Change in exercise self-efficacy
大体时间：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
Change in contextualized stress: stress states
大体时间：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
Change in Super Woman Schema (SWS)
大体时间：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.
Baseline, Week 8, and Month 3

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of North Carolina, Chapel Hill

合作者

National Heart, Lung, and Blood Institute (NHLBI)

调查人员

  • 首席研究员：Jada Brooks、University of North Carolina, Chapel Hill

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月7日

初级完成 (估计的)

2026年7月1日

研究完成 (估计的)

2026年7月1日

研究注册日期

首次提交

2026年5月5日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年6月25日

上次提交的符合 QC 标准的更新

2026年6月22日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 21-1762
  • 5R34HL158947-03 (美国 NIH 拨款/合同)
  • 5R34HL158947-02 (美国 NIH 拨款/合同)
  • 1R34HL158947-01 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

IPD 共享时间框架

beginning 9 and continuing for 24 months

IPD 共享访问标准

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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