NCT07581899招募中不适用
MIND Your Heart Study for American Indian Women
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Research assistants collecting research data
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention Group
Experimental
Intervention Group: 8-week culturally-adapted intervention
干预措施: Culturally-adapted intervention to improve cardiovascular health in American Indian women (Behavioral)
研究者
研究点 (1)
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