Methods: We will discuss our CBPR approach used to develop a hypertension intervention based on hula, the traditional dance of Hawai‘i, as its core component that engaged both the kumu hula (keeper of the tradition tradition), other Native Hawaiian stakeholders, and clinicians. We will also discuss the process of selecting a study design that balanced both community concerns and the “gold standard” convention in intervention testing, which led us to a randomized controlled trial with a waitlist control (RCT-WC). The RCT-WC was used to test the efficacy of the 6-month hula-based intervention in reducing SBP and 10-year CVD risk in 150 adult Native Hawaiians with uncontrolled hypertension.
Results: Our CBPR approach led to the cultural acceptance of our hula-based intervention by the hula community as well as other Native Hawaiian stakeholders – an important aspect of culturally grounded approaches to intervention development. It also allowed for the standardization of our intervention while adhering to both Hawaiian cultural and Western scientific conventions. A RCT with waitlist control was found acceptable because every participant, regardless of randomization assignment, would eventually be offered the intervention. We exceeded our initial recruitment target of 250 to 277 participants, with 80% retention at 6-months in the intervention arm and 84% in the waitlist control arm. There were challenges to our RCT WC, such as potential cross-contamination and community members being uncomfortable with providing group assignment to participants. We anticipate being able to also report the final outcomes of our RCT WC design to link the process to its outcomes.
Conclusions: We successfully conducted the largest non-traditional RCT among Native Hawaiians to date. Our CBPR approach to intervention development led to a standardized culturally grounded intervention that met cultural and scientific standards. Our RCT WC design, embedded within a larger CBPR approach and partnership, yielded a high recruitment and retention rate of Native Hawaiian participants in a clinical trial, which challenges the prevailing assumption that it is difficult to recruit and retain Indigenous People in a RCT.