The KaHOLO Project: Preventing Cardiovascular Disease in Native Hawaiians

Hypertension Clinical Trial

— KaHOLO  

Official title:

The KaHOLO Project: Preventing Cardiovascular Disease in Native Hawaiians

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02620709
• Other study ID #: KaHOLO Project
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2021

Study information

• Verified date: March 2020
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 275
• Est. completion date: January 2021
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Native Hawaiian ancestry

• Physician diagnosed HTN

• Continued SBP>140

• Physicians approval to participate in moderate PA

• No prior CVD history

Exclusion Criteria:

• Pregnant

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension

Intervention

Behavioral:
• Hula intervention
Hula and heart health education

Locations

Country	Name	City	State
United States	University of Hawaii, John A Burns School of Medicine, Department of Native Hawaiian Health	Honolulu	Hawaii

Sponsors (6)

Lead Sponsor	Collaborator
University of Hawaii	Hui No Ke Ola Pono, Inc., I Ola Lahui, Inc., Ke Ola Mamo, Kula No Na Po'e Hawaii, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with decreased scores on the Perceived Ethnic Discrimination Scale		3 months, 6 months, and 12 months
Other	Number of Participants with improved monthly physical activity levels as assessed by the Physical Activity Questionnaire		3 months, 6 months, and 12 months
Other	Number of participants with increased scores on the Medical Outcomes Study (MOS) 36-item Social Support Survey		3 months, 6 months, and 12 months
Other	Number of participants with decreased scores on the Perceived Stress Scale		3 months, 6 months, and 12 months
Other	Number of participants with increased scores of the Exercise Self-Efficacy Scale		3 months, 6 months, and 12 months
Other	Number of participants with increased scores on the Native Hawaiian Identity Scale		3 months, 6 months, and 12 months
Primary	Change in participants' systolic blood pressure at each time frame from baseline		3 months, 6 months, and 12 months
Secondary	Change in participants' Framingham Risk Score of 10 year CVD risk at each time frame from baseline		3 months, 6 months, and 12 months