Natives Engaged in Alzheimers Research - 'Ike Kupuna (NEAR)

Natives Engaged in Alzheimers Research - 'Ike Kupuna (Elder Wisdom) Project

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment; Subjective Cognitive Impairment
• Intervention / Treatment: Behavioral: Ola Mau i ka Hula

Detailed Description

This study will conduct a pragmatic group-randomized trial (GRT) with NHPIs aged 50-75 years with at least 1 of 4 modifiable vascular risk factors for ADRD (hypertension, hyperglycemia, obesity, or dyslipidemia) and either SCI or MCI using a wait-list control design to test the effects of the hula-based intervention. The primary outcomes will be vascular risk factors for ADRD and subjective cognitive complaints. Secondary outcomes will include measures of cognitive performance, physical function, and mental health.

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janice K Worthington, MPH; Phone Number: 8086921023; Email: ikekupuna@gmail.com

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Recruiting
      • Kula No Na Po'e
      • Contact: Adrienne Dillard, PhD; Phone Number: 808-692-1023; Email: ikekupuna@gmail.com
    • Honolulu, Hawaii, United States, 96819
      • Recruiting
      • Kokua Kalihi Valley
      • Contact: Sheryl Yoshimura, RD; Phone Number: 808-692-1023; Email: ikekupuna@gmail.com
    • Wailuku, Hawaii, United States, 96793
      • Recruiting
      • Hui No Ke Ola Pono
      • Contact: Malia Purdy, PhD; Phone Number: 808-692-1023; Email: ikekupuna@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. self-reported Native Hawaiian or other Pacific Islander ancestry;
2. ages 50+ but not older than 75 (optimal age range for preventing future dementia in people with cognitive impairment, above 75 is not likely to benefit from this study given their advance age);
3. has subjective cognitive impairment (SCI) or mild cognitive impairment (MCI);
4. have a diagnosis of hypertension, diabetes, dyslipidemia, or obesity (body-mass-index ≥ 30 kg/m2);
5. physically able and willing to engage in moderate physical activity necessary for Hula; and
6. physician's approval to participate in moderate physical activity

Exclusion Criteria:

1. currently pregnant;
2. already actively practicing Hula at least once per week; or
3. clinical diagnosis of ADRD (mild to severe); or
4. current diagnosed major depressive disorder at moderate or greater stage, or moderate or greater depression on the Center for Epidemiological Studies Depression Scale (CES-D).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Ola Mau i ka Hula; 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.; Other Names: Ola Mau
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in participants' systolic blood pressure at each time frame from baseline	Vascular risk factor assessed using Omron©HEM-907XL	3 months, 8 months, 12 months
Change in participants' Hemoglobin A1c at each time frame from baseline	Vascular risk factor assessed using Alere Cholestech LDX® System	12 months
Change in participants' total cholesterol at each time frame from baseline	Vascular risk factor assessed using Alere Cholestech LDX® System	3 months, 8 months, 12 months
Change in participants' body mass index at each time frame from baseline	Vascular risk factor assessed using Tanita BWB800AS scale	3 months, 8 months, 12 months
Change in participants' Cognitive Change Index score at each time frame from baseline	Cognitive function assessed using Cognitive Change Index assessment	3 months, 8 months, 12 months
Change in participants' Number Symbol Coding Test score at each time frame from baseline	Cognitive function assessed using Number Symbol Coding Test	3 months, 8 months, 12 months
Change in participants' overall Cognivue score at each time frame from baseline	Cognitive function assessed using Cognivue device	3 months, 8 months, 12 months
Change in participants' overall Quick Dementia Rating System score at each time frame from baseline	Cognitive function assessed using Quick Dementia Rating System assessment	3 months, 8 months, 12 months

Collaborators and Investigators

• Sponsor: University of Hawaii
• Investigators: Principal Investigator: Joseph K Kaholokula, PhD, University of Hawaii

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: behavioral intervention; Alzheimer's disease; MCI; SCI; Vascular dementia; Alzheimer's disease and related dementias; ADRD; Native Hawaiian and Pacific Islander; NHPI; Hula; cultural based intervention
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 'Ike Kupuna

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No