'Ai Pono Cooking Demonstrations

NCT ID: NCT06526650

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1780 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-12
• Study Completion Date: 2028-03-13

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.

Detailed Description

In Years 1 - 5, the investigators will hold quarterly cooking demonstrations and cultural lessons for a total of 36 events. The lessons will be aimed at improving family and community eating environments of participants and social cohesion of these communities. Attendance at each lesson will be limited to 30 individuals. Attendees will register via REDCap using their names and email addresses. There is no limit to how many lessons an individual can attend, but after the first lesson the investigators reserve 15 of the 30 spots for people who have not attended previously, as identified by their registration information. At each quarterly event, the investigators survey participants to assess their reaction to the lesson, their vegetable and fruit intake, self-efficacy for healthy diet, and perceptions of community cohesion. Surveys will take ~5-10 minutes to complete. Additionally, the investigators will survey random samples of homestead households (n = 20 per homestead, total n = 140 per year) in Projects Years 1 - 5. Total sample for this activity is 700. Each sample will be selected independent of previous samples, and it is possible the same households will be sampled multiple times.

Conditions

Type 2 Diabetes; Hypertension; Dyslipidemias; Overweight and Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

'Ai Pono

Intervention Type: OTHER

"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.

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

American Heart Association

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire Ing, DrPH

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Kulani DeSimone, B.S.

Role: STUDY_CHAIR

Graduate Assistant

Locations

Kula no na Poe Hawaii

Honolulu, Hawaii, United States

Site Status: RECRUITING

Kapolei Community Development Coalition

Kapolei, Hawaii, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Claire Ing, DrPH

Role: CONTACT

clairemt@hawaii.edu

8086921042

Ki'i Aweau

Role: CONTACT

Facility Contacts

Meghan Kenney

Role: primary

meghan@kula-papakolea.org

8085208997

Chantal Keliihoomalu

Role: primary

executivedirector@kapoleiheritage.org

Other Identifiers

R01HL168858

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PILI 'Āina 3

Identifier Type: -

Identifier Source: org_study_id