Natives Engaged in Alzheimers Research - 'Ike Kupuna

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor
University of Hawaii
Study ID
NCT05534607
Status
Recruiting

Conditions

  • Mild Cognitive Impairment
  • Subjective Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Ola Mau i ka Hula — BEHAVIORAL
    The first 3 months of the hula-based intervention program was designed and standardized as a culturally-based physical activity (PA) that includes 15 minutes of ADRD education and intervention orientation with 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 8 participants, providing them with the opportunity to engage-in this social support network. For the remaining 5 months of the Ola Mau i ka Hula Program, hula lessons led by the kumu hula will be reduced to once a month for 60 min. In addition, the intervention group will meet with a community-peer educator weekly over this 5-month period. Each meeting will be 90 minutes in length with 60 minutes of hula practice following the same format as previous classes, and 30 minutes will cover the PILI Lifestyle Plan curriculum and cultural-based cognitive exercises, alternating weekly.

Study Details

This study will conduct a group randomized trial to test the effects of a hula-based intervention in improving vascular risk factors for ADRD and cognitive complaints and function over 12 months.

Key Dates

Start date
Sep 15, 2022
Status verified
Jul 2024
Primary completion
Jun 15, 2025
Completion
Apr 30, 2027

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention group
    The intervention group will immediately receive the Ola Mau i ka Hula intervention after randomization for 12 months. The intervention program is 8 months with a 4 month self-monitoring period.
  • No Intervention: Wait-list control group
    After baseline data collection, participants randomized to the wait-list control arm will not receive the Ola Mau i ka Hula Program while their counterparts who were randomized to the intervention arm are undergoing the intervention program. Thus, they will not be offered the intervention until after the intervention arm is completed and their 12-month follow-up data collection is completed. They will only receive the educational component of the intervention from us during this 12-month period but they will be instructed to continue with their routine medical care as usual. Wait-list control group will be offered the opportunity to receive intervention at the conclusion of 12 month assessment period, regardless of whether they were retained for the full 12 months of data collection.

Primary Outcome Measure

Change in participants' systolic blood pressure at each time frame from baseline [ Time Frame: 3 months, 8 months, 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Kokua Kalihi ValleyHonoluluHawaii96819
Sheryl Yoshimura, RD
808-692-1023
Kula No Na Po'eHonoluluHawaii96813
Adrienne Dillard, PhD
808-692-1023
Hui No Ke Ola PonoWailukuHawaii96793
Malia Purdy, PhD
808-692-1023

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