Recruiting

Observational Study

Sponsor:

University of Hawaii

Code:

NCT06526650

Conditions

Type 2 Diabetes

Hypertension

Dyslipidemias

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

'Ai Pono

Study Details

Brief summary:

Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.

Conditions

Type 2 Diabetes

Hypertension

Dyslipidemias

Overweight and Obesity

Study ID

NCT06526650

Start date

Feb 12, 2025

Status verified date

Apr, 2025

Completion date

Aug, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 18+ (looking for older adults)
  • Native Hawaiian resident in a participating homestead
  • Overweight or obese (BMI ≥ 25 kg/m\^2)
  • Prior diagnosis of type 2 diabetes or pre-diabetes, hypertension, and/or dyslipidemia (LDL cholesterol ≥ 130 mg/dL)
  • Capable of 150 minutes of moderate physical activity (e.g., brisk walking) per week
  • Willing and able to participate in all aspects of the individual and household-level intervention
  • Fluent in written and spoken English

Exclusion Criteria:

  • No children
  • Pregnancy
  • Serious illness such as cancer or chronic pain that may contraindicate full participation

Study Design

Enrollment

1780 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Aim 3: Community Level Intervention

Aim 3 is community-driven, supports the overall goal of the PILI 'Āina project, allows all members of the community to benefit, and is strongly promoted within the community. The investigators will design and implement 'Ai Pono, a community-level component that can operate in tandem with PILI 'Āina. This component will not be tested in the group-randomized trial. Instead, all 7 communities will implement 'Ai Pono for the full study period.

Interventions

'Ai Pono

"Hands-on Cooking and Cultural Lessons" These lessons will be widely advertised. Each 2-hour presentation will involve hands-on cooking demonstrations and tastings, accompanied by lessons on the cultural significance of featured food items. Demonstrations will link the consumption of vegetables (e.g., sweet potato, breadfruit, kalo) to Native Hawaiian (NH) history and traditional beliefs to help participants rediscover their heritage through the meals they prepare.

Primary outcome measure

  • Family Environment [ Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year ]
  • Nutrition Environment [ Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year ]
  • Social Cohesionn [ Time Frame: Baseline, 1-year, 2-year, 3-year, 4-year ]

Central Contacts and Locations

Central contacts

Claire Ing, DrPH

8086921042clairemt@hawaii.edu

Locations

Kula no na Poe Hawaii

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Meghan Kenney

8085208997meghan@kula-papakolea.org

Kapolei Community Development Coalition

Recruiting

Kapolei, Hawaii, United States, 96707

Contacts

Chantal Keliihoomalu

executivedirector@kapoleiheritage.org

More Information

Sponsor

University of Hawaii

Last update posted

Mar 4, 2026

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by University of Hawaii on 2026-03-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.