NCT06526650

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,780

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
27mo left

Started Feb 2025

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Feb 2025Aug 2028

First Submitted

Initial submission to the registry

June 7, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

February 12, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

March 4, 2026

Status Verified

April 1, 2025

Enrollment Period

3.3 years

First QC Date

June 7, 2024

Last Update Submit

March 2, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Family Environment

    Three subscales, Cohesion, Expressiveness, and Conflict, assess the degree of commitment and support family members provide for one another, the extent to which family members are encouraged to express their feelings directly, and the amount of openly expressed anger and conflict among family members.

    Baseline, 1-year, 2-year, 3-year, 4-year

  • Nutrition Environment

    The perceived 9-item nutrition environment will be measured by the Gustafson Perceived Nutrition Environment Measures questionnaire, which examines perceived access and availability of healthy foods within \~1 mile of the participant's home, and the availability and affordability of produce in the participant's primary food store. The responses and scores vary depending on the question including 0- disagree, 1-agree, and 0-not important, 1-slightly important, 2-moderately important, 3- important, 4-very important. Higher scores indicate higher perceived access and availability of food.

    Baseline, 1-year, 2-year, 3-year, 4-year

  • Social Cohesionn

    4-item subscale of the neighborhood level stressors which asks about perceived shared values and trust.

    Baseline, 1-year, 2-year, 3-year, 4-year

Secondary Outcomes (3)

  • Diet Self-Efficacy

    Baseline, 1-year, 2-year, 3-year, 4-year

  • Food Literacy

    Baseline, 1-year, 2-year, 3-year, 4-year

  • Social Support

    Baseline, 1-year, 2-year, 3-year, 4-year

Other Outcomes (9)

  • Cultural Identity

    Baseline, 1-year, 2-year, 3-year, 4-year

  • Demographic Data- Date of Birth

    Baseline, 1-year, 2-year, 3-year, 4-year

  • Demographic Data- Biological Sex

    Baseline, 1-year, 2-year, 3-year, 4-year

  • +6 more other outcomes

Study Arms (1)

Aim 3: Community Level Intervention

OTHER

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.

Other: 'Ai Pono

Interventions

"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.

Aim 3: Community Level Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kula no na Poe Hawaii

Honolulu, Hawaii, 96813, United States

RECRUITING

Kapolei Community Development Coalition

Kapolei, Hawaii, 96707, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HypertensionDyslipidemiasOverweightObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Claire Ing, DrPH

    Principal Investigator

    PRINCIPAL INVESTIGATOR
  • Kulani DeSimone, B.S.

    Graduate Assistant

    STUDY CHAIR

Central Study Contacts

Claire Ing, DrPH

CONTACT

Ki'i Aweau

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2024

First Posted

July 30, 2024

Study Start

February 12, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

March 4, 2026

Record last verified: 2025-04

Locations