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Clinical Trials/NCT06964633
NCT06964633Not yet recruitingNot Applicable

The Ku Ola Project

University of Hawaii1 site in 1 country600 target enrollmentStarted: November 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
600
Locations
1
Primary Endpoint
Surveys

Study Overview

Brief Summary

The Ku Ola Project: The goal of this study is to determine if community-based discussion groups and small educational sessions enhance health awareness and behaviors among Native Hawaiian men. The study will examine if these interventions improve participants' health knowledge, attitudes, and self-efficacy while fostering local networks to support ongoing health promotion. Participants will engage in group discussions and educational sessions designed to build capacity and encourage healthy lifestyle choices.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Inclusion Criteria Self-identified as male At least 18 years of age Hawaii residency Able to read and understand English

Exclusion Criteria

  • •Under 18 years of age Not proficient in English Any medical condition or situation that, in the investigator's judgment, would make continued participation not in the participant's best interest

Arms & Interventions

Educational & Behavioral Intervention

Experimental

Participants take part in Kū Ola kūkākūkā (discussion group) modules-each a 2-hour session integrating a health topic (e.g., colorectal, lung, oro/nasopharyngeal cancer) with Hawaiian cultural content-complete pre- and post-test surveys, draft a commitment contract, and, where applicable, undergo cancer screening and receive follow-up support.

Intervention: Kūkākūkā Discussion Sessions (Behavioral)

Outcomes

Primary Outcomes

Surveys

Time Frame: Pretest immediately before each module and post-test immediately after completion (within the same day).

Participants complete pretest and post-test surveys gathering demographic data and module-specific health information and knowledge to evaluate program effectiveness.

Commitment Contract

Time Frame: From immediately after the post-test survey to the six-month follow-up call.

After completing the post-test survey, participants draft a commitment contract proposing a specific health behavior change and leave their contact information so Kū Ola staff can follow up six months later to offer support and collect outcome data.

Evaluation:

Time Frame: Immediately following each session.

After each session, participants complete short-answer and multiple-choice evaluation questions assessing how well the session fostered health-related communication and their perceived learning.

Screening

Time Frame: Within six months of the commitment contract.

The proportion of eligible participants who complete their committed cancer screening test (e.g., FIT or PSA) as recorded by the PI and communicated to primary care physicians.

Discussion

Time Frame: At the end of each module session (each session is 2 hours long)

One-sentence description: Thematic analysis of anonymized audio-recorded group discussions and facilitator notes from each module, capturing key insights and participant engagement.

Tracking Groups and Facilitators

Time Frame: From the date the first participant completes their initial module session through six months after the last participant completes their post-test survey (estimated up to 12 months).

Aggregate counts of men reached, number of modules delivered, and number of facilitators trained, tracked continuously in the Kū Ola database.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Hawaii
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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