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临床试验/NCT02620709
NCT02620709Unknown不适用

The KaHOLO Project: Preventing Cardiovascular Disease in Native Hawaiians

University of Hawaii2 个研究点 分布在 1 个国家目标入组 275 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
275
试验地点
2
主要终点
Change in participants' systolic blood pressure at each time frame from baseline

研究概览

简要总结

This project is a community-engaged, randomized control trial of hula, the indigenous dance form of Native Hawaiians (NH), among 250 NHs with hypertension living in Hawaii and Washington State. Investigators will compare the effects of a 6-month intervention, called the KaHOLO Program, delivered by trained peer educators to a wait-list control condition on blood pressure and 10-year cardiovascular risk. The intervention will be comprised of hula plus hypertension self-care education program. Investigators will also examine the mediating effects of health behaviors, self-regulation, psychosocial, and socio-cultural factors on blood pressure reduction. The ultimate goal is to develop and test a culturally-appropriate, acceptable, and effective intervention that can be delivered and sustained in community settings.

详细描述

Native Hawaiians (NH) have higher rates of chronic diseases, such as cardiovascular disease (CVD), diabetes, and cancer. Hypertension (HTN), an important modifiable risk factor for CVD, is 70% higher in Native Hawaiians (NH) than in Whites. In fact, NH are 3-4 times more likely to develop CVD conditions, such as stroke and coronary heart disease, and at a younger age. In addition to prescribed medication, improvements in HTN can be achieved through increased physical activity (PA) and self-management education (e.g. stress management, reduces sodium intake, weight-loss, and smoking cessation). Yet, many commonly prescribed PA, such as jogging and use of treadmills, are difficult for NH to initiate and maintain because of socioeconomic barriers and lack of alignment with NH preferred modes of living and cultural values (i.e. familial interdependence, group-based PA, cultural PA).

This research study uses hula, the traditional dance form of NH and hallmark of NH culture, as the PA basis for a culturally relevant and sustainable CVD prevention program targeting HTN management. Hula training is popular, not only Hawai'i, but across the U.S. through the 784 hālau hula (hula schools) found in most States. Using a community-based participatory research (CBPR) framework, a hula-based CVD health intervention was strongly endorsed by Kumu hula (hula experts and guardians of hula traditions), NH individuals, and communities. Further, hula was determined to yield metabolic equivalent of energy expenditure as a moderate and vigorous intensity PA. Data from a pilot CBPR randomized control trial (RCT) study found that 60 minutes of hula training twice a week for 12 weeks reduced systolic blood pressure (BP) by 7.5 mmHg (SD=16.5) more than the control group, but the long-term effects were mixed and the study did not assess CVD risk.

Interestingly, the pilot intervention also improved social functioning, reduced physical pain, and perceived racial discrimination, suggesting a possible psychosocial and socio-cultural mechanism by which the intervention affects BP. In this study a CBPR guided RCT of 250 NH with physician-diagnosed HTN in Hawai'i and Washington State is offered. The effects will be compared of a 6-month intervention that combines hula training and brief culturally-tailored HTN self-management education delivered by peer educators and Kumu hula to a wait-list control group in reducing systolic BP and CVD risk scores. It will also be determined the mediating effects of health behaviors (e.g., smoking), self-regulation, and psychosocial (e.g., social support), and socio-cultural factors (e.g., perceived racism) on blood pressure reduction. The goal is to build on the existing widespread infrastructure of hālau hula and NH organizations to deliver a sustainable, culturally-preferred CVD prevention program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Native Hawaiian ancestry
  • Physician diagnosed HTN
  • Continued SBP>140
  • Physicians approval to participate in moderate PA
  • No prior CVD history

排除标准

  • 未提供

结局指标

主要结局

Change in participants' systolic blood pressure at each time frame from baseline

时间窗: 3 months, 6 months, and 12 months

次要结局

  • Change in participants' Framingham Risk Score of 10 year CVD risk at each time frame from baseline(3 months, 6 months, and 12 months)

研究者

发起方
University of Hawaii
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph Keawe'aimoku Kaholokula

Chair and Associate Professor

University of Hawaii

研究点 (2)

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