Natives Engaged in Alzheimers Research - 'Ike Kupuna

NCT ID: NCT05534607

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-15

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mild Cognitive Impairment Subjective Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study uses a wait list control design, where the wait-list control group is offered the intervention at the completion of the intervention group's 12-month intervention and assessment period.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ola Mau i ka Hula

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Ola Mau

Eligibility Criteria

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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).
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Hawaii

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph K Kaholokula, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii

Locations

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Kula No Na Po'e

Honolulu, Hawaii, United States

Site Status RECRUITING

Kokua Kalihi Valley

Honolulu, Hawaii, United States

Site Status RECRUITING

Hui No Ke Ola Pono

Wailuku, Hawaii, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Janice K Worthington, MPH

Role: CONTACT

8086921023

Facility Contacts

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Adrienne Dillard, PhD

Role: primary

808-692-1023

Sheryl Yoshimura, RD

Role: primary

808-692-1023

Malia Purdy, PhD

Role: primary

808-692-1023

Other Identifiers

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'Ike Kupuna

Identifier Type: -

Identifier Source: org_study_id

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