- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02620709
The KaHOLO Project: Preventing Cardiovascular Disease in Native Hawaiians (KaHOLO)
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- University of Hawaii, John A Burns School of Medicine, Department of Native Hawaiian Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hula intervention
Participants randomized to the intervention arm will receive the 6-month KaHOLO Program within 1 week of baseline data collection. The first 3 months of the KaHOLO was designed and standardized as a culturally-based PA, which includes 12 weeks of hula lessons. These hula lessons consist of two 60 minute classes per week over 12 weeks. Each hula lesson will consist of 15 participants, providing with the opportunity to engage in social support network. The last three months of the program will be reduced to once a week sessions. One week will consist of hula lessons for 60 minutes. The remaining 3 weeks will consist of the intervention group meeting for 45 minutes with the community-peer educator. |
Hula and heart health education
|
No Intervention: Wait-List Control
After baseline data collection and education, participants randomized to the wait-list control arm will not receive the KaHOLO Program while their counterparts who were randomized to the intervention arm are undergoing the intervention program.
Thus, they will not receive the intervention for 6 months until after the intervention arm is completed and their 6 month follow-up data collection is completed.
They will not receive any other intervention from us during the 6 month period but they will be instructed to continue with their routine medical care as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in participants' systolic blood pressure at each time frame from baseline
Time Frame: 3 months, 6 months, and 12 months
|
3 months, 6 months, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in participants' Framingham Risk Score of 10 year CVD risk at each time frame from baseline
Time Frame: 3 months, 6 months, and 12 months
|
3 months, 6 months, and 12 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with decreased scores on the Perceived Ethnic Discrimination Scale
Time Frame: 3 months, 6 months, and 12 months
|
3 months, 6 months, and 12 months
|
Number of Participants with improved monthly physical activity levels as assessed by the Physical Activity Questionnaire
Time Frame: 3 months, 6 months, and 12 months
|
3 months, 6 months, and 12 months
|
Number of participants with increased scores on the Medical Outcomes Study (MOS) 36-item Social Support Survey
Time Frame: 3 months, 6 months, and 12 months
|
3 months, 6 months, and 12 months
|
Number of participants with decreased scores on the Perceived Stress Scale
Time Frame: 3 months, 6 months, and 12 months
|
3 months, 6 months, and 12 months
|
Number of participants with increased scores of the Exercise Self-Efficacy Scale
Time Frame: 3 months, 6 months, and 12 months
|
3 months, 6 months, and 12 months
|
Number of participants with increased scores on the Native Hawaiian Identity Scale
Time Frame: 3 months, 6 months, and 12 months
|
3 months, 6 months, and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph K Kaholokula, PhD, University of Hawaii
Publications and helpful links
General Publications
- Railey AF, Muller C, Noonan C, Schmitter-Edgecombe M, Sinclair K, Kim C, Look M, Kaholokula JK. Cost Effectiveness of a Cultural Physical Activity Intervention to Reduce Blood Pressure Among Native Hawaiians with Hypertension. Pharmacoecon Open. 2022 Jan;6(1):85-94. doi: 10.1007/s41669-021-00291-6. Epub 2021 Aug 13.
- Kaholokula JK, Look MA, Wills TA, de Silva M, Mabellos T, Seto TB, Ahn HJ, Sinclair KA, Buchwald D; Ka-HOLO Project. Ka-HOLO Project: a protocol for a randomized controlled trial of a native cultural dance program for cardiovascular disease prevention in Native Hawaiians. BMC Public Health. 2017 Apr 17;17(1):321. doi: 10.1186/s12889-017-4246-3.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KaHOLO Project
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Completed
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
Clinical Trials on Hula intervention
-
University of HawaiiCompletedCervical Cancer | Breast Cancer | Physical Activity | Ovarian Cancer | Endometrial CancerUnited States
-
University of HawaiiCompleted
-
University of HawaiiRecruitingMild Cognitive Impairment | Subjective Cognitive ImpairmentUnited States
-
Biolux Research Holdings, Inc.TerminatedOrthodontic Tooth MovementCanada
-
University of California, San FranciscoNational Cancer Institute (NCI)CompletedColorectal Carcinoma | Healthy Subject | Health Status UnknownUnited States
-
University of FloridaCompletedSensitivityUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Institute on Minority Health and...RecruitingHuman Papillomavirus InfectionUnited States
-
Ohio State University Comprehensive Cancer CenterCompleted
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnCancer Survivor | Peripheral Sensory Neuropathy
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityRecruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Prognostic... and other conditionsUnited States