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 — BEHAVIORALThe 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 groupThe 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 groupAfter 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
- Janice K Worthington, MPH8086921023
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Kokua Kalihi Valley | Honolulu | Hawaii | 96819 | |
| Kula No Na Po'e | Honolulu | Hawaii | 96813 | |
| Hui No Ke Ola Pono | Wailuku | Hawaii | 96793 |
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