HypertensionKaHOLONCT02620709
The KaHOLO Project: Preventing Cardiovascular Disease in Native Hawaiians
A study testing Hula intervention in people with Hypertension, run by University of Hawaii at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Hula intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Native Hawaiian ancestry
- Physician diagnosed HTN
- Continued SBP>140
- Physicians approval to participate in moderate PA
- No prior CVD history
Who cannot join
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hawaii, John A Burns School of Medicine, Department of Native Hawaiian Health
Honolulu, Hawaii, 96813
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Hula intervention
- Keywords
- Native Hawaiians, Community-based participatory research, Health disparities, Minority populations, Chronic disease
- Medical subject headings
- Hypertension, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hula interventionBehavioural
Hula and heart health education
| Study group | Role | What they receive |
|---|---|---|
| Hula intervention | Experimental | 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. Receives: Behavioral: Hula intervention |
| Wait-List Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in participants' systolic blood pressure at each time frame from baseline
Measured: 3 months, 6 months, and 12 months
Secondary outcomes (1)
Change in participants' Framingham Risk Score of 10 year CVD risk at each time frame from baseline
Measured: 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionMar 2019
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- I Ola Lahui, Inc., Ke Ola Mamo, University of Washington, Hui No Ke Ola Pono, Inc., Kula No Na Po'e Hawaii
- Responsible party
- Principal investigator, Joseph Keawe'aimoku Kaholokula, University of Hawaii
- Investigators
- Joseph K Kaholokula, PhD, Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620709
- Sponsor's protocol ID
- KaHOLO Project
- Acronym
- KaHOLO
- Status last verified
- Mar 2020
- First submitted
- 23 Nov 2015
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 34389923Kaholokula 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.
PubMed 28415975
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The KaHOLO Project: Preventing Cardiovascular Disease in Native Hawaiians
- ClinicalTrials.gov ID
- NCT02620709
- Acronym / sponsor ID
- KaHOLO / KaHOLO Project
- Conditions
- Hypertension
- Keywords
- Native Hawaiians, Community-based participatory research, Health disparities, Minority populations, Chronic disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- I Ola Lahui, Inc., Ke Ola Mamo, University of Washington, Hui No Ke Ola Pono, Inc., Kula No Na Po'e Hawaii
- Study start
- Jan 2016
- Primary completion
- Mar 2019 (actual)
- Study completion
- Jan 2021 (estimated)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hula intervention | Experimental | Behavioral: Hula interventionParticipants 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. |
| Wait-List Control | No intervention | –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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Native Hawaiian ancestry
- Physician diagnosed HTN
- Continued SBP>140
- Physicians approval to participate in moderate PA
- No prior CVD history
Key exclusion criteria (1 listed)
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hula interventionHula and heart health education | Behavioural | Hula intervention |
Primary outcome
Change in participants' systolic blood pressure at each time frame from baseline
Time frame: 3 months, 6 months, and 12 months
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 34389923Railey 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.
- Derived from this study: PubMed 28415975Kaholokula 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph K Kaholokula, PhD principal investigator
University of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hula intervention in people with Hypertension, run by University of Hawaii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participants' systolic blood pressure at each time frame from baseline (time frame: 3 months, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02620709, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.