The KaHOLO Project: Preventing Cardiovascular Disease in Native Hawaiians

NCT02620709 | Unknown DMC

• 1 other identifier: KaHOLO Project
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Native Hawaiians; Community-based participatory research; Health disparities; Minority populations; Chronic disease

Outcome Measures

Primary Outcomes (1)

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

  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

  3 months, 6 months, and 12 months

Other Outcomes (6)

• Number of Participants with decreased scores on the Perceived Ethnic Discrimination Scale

  3 months, 6 months, and 12 months

• Number of Participants with improved monthly physical activity levels as assessed by the Physical Activity Questionnaire

  3 months, 6 months, and 12 months

• Number of participants with increased scores on the Medical Outcomes Study (MOS) 36-item Social Support Survey

  3 months, 6 months, and 12 months

Study Arms (2)

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.

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.

Interventions

Hula intervention BEHAVIORAL

Hula and heart health education

Hula intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant

Sponsors & Collaborators

• University of Hawaii: lead
• I Ola Lahui, Inc.: collaborator
• Ke Ola Mamo: collaborator
• University of Washington: collaborator
• Hui No Ke Ola Pono, Inc.: collaborator
• Kula No Na Po'e Hawaii: collaborator

Study Sites (1)

University of Hawaii, John A Burns School of Medicine, Department of Native Hawaiian Health

Honolulu, Hawaii, 96813, United States

Location

Related Publications (2)

• 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.

  PMID: 34389923 DERIVED

• 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.

  PMID: 28415975 DERIVED

MeSH Terms

Conditions

Hypertension; Chronic Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph K Kaholokula, PhD

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Associate Professor

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 3, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: January 1, 2021
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

US (1)