Type 2 DiabetesNCT06526650
'Ai Pono Cooking Demonstrations
A study testing 'Ai Pono in people with Type 2 Diabetes and Hypertension, run by University of Hawaii at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Hypertension, Dyslipidemias
- What is being tested?
- 'Ai Pono
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,780 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Feb 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No children
- Pregnancy
- Serious illness such as cancer or chronic pain that may contraindicate full participation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ki'i Aweau contact
United States2 sites, 2 recruiting
- Recruiting
Kula no na Poe Hawaii
Honolulu, Hawaii, 96813
Meghan Kenney, 8085208997, meghan@kula-papakolea.org
- Recruiting
Kapolei Community Development Coalition
Kapolei, Hawaii, 96707
Chantal Keliihoomalu, executivedirector@kapoleiheritage.org
About this study
Official title: The PILI 'Āina Project
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.
Read the 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
- Being tested
- 'Ai Pono
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Ai PonoOther
"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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 'Ai Pono |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1-year, 2-year, 3-year, 4-year
Secondary outcomes (3)
Diet Self-Efficacy
The 11-item Diet Self Efficacy Scale will measure self-efficacy in avoiding tempting high caloric food and managing social and internal cues and negative emotions. The responses and scores range from 1-strongly disagree, 2-somewhat disagree, 3-neutral, 4-somewhat agree, and 5-strongly agree. Higher scores indicate greater self-efficacy with diet.
Measured: Baseline, 1-year, 2-year, 3-year, 4-year
Food Literacy
Food literacy, defined as the ability to make healthy food choices in different settings and situations, will be assessed by the 11-item self-perceived food literacy scale, which encompasses knowledge, skills, and behaviors pertinent to planning, selecting, preparing, and eating healthy food. The responses and scores range from 1-not at all/never, 2-disagree, 3-slightly disagree, 4- slightly agree, 5-yes/always. Higher scores indicate greater food literacy.
Measured: Baseline, 1-year, 2-year, 3-year, 4-year
Social Support
Social support for a healthy diet will be measured as the perceived support that people who make dietary changes receive from family and friends. An 11-item questionnaire on social support will be used to ask participants' perceived level of support from friends and family regarding diet choices. The responses and scores range from 1-strongly disagree, 2-somewhat disagree, 3-neutral, 4-somewhat agree, and 5-strongly agree. Higher scores indicate greater social support.
Measured: Baseline, 1-year, 2-year, 3-year, 4-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start12 Feb 2025
- Primary completionJun 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), American Heart Association, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Claire Ing, DrPH, Principal investigator, Principal InvestigatorKulani DeSimone, B.S., Study chair, Graduate Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526650
- Sponsor's protocol ID
- PILI 'Āina 3
- Other IDs
- R01HL168858
- Status last verified
- Apr 2025
- First submitted
- 7 Jun 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PILI 'Āina Project
- ClinicalTrials.gov ID
- NCT06526650
- Acronym / sponsor ID
- PILI 'Āina 3
- Conditions
- Type 2 Diabetes, Hypertension, Dyslipidemias, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,780 participants (estimated)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), American Heart Association, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aim 3: Community Level Intervention | Other | Other: 'Ai PonoAim 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- No children
- Pregnancy
- Serious illness such as cancer or chronic pain that may contraindicate full participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| '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. | Other | Aim 3: Community Level Intervention |
Primary outcome
Family Environment
Time frame: Baseline, 1-year, 2-year, 3-year, 4-year
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.
Nutrition Environment
Time frame: Baseline, 1-year, 2-year, 3-year, 4-year
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.
Social Cohesionn
Time frame: Baseline, 1-year, 2-year, 3-year, 4-year
4-item subscale of the neighborhood level stressors which asks about perceived shared values and trust.
3 secondary outcomes
Diet Self-Efficacy
Time frame: Baseline, 1-year, 2-year, 3-year, 4-year
Food Literacy
Time frame: Baseline, 1-year, 2-year, 3-year, 4-year
Social Support
Time frame: Baseline, 1-year, 2-year, 3-year, 4-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ki'i Aweau contact
Claire Ing, DrPH principal investigator
Principal Investigator
Kulani DeSimone, B.S. study chair
Graduate Assistant
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Ai Pono in people with Type 2 Diabetes and Hypertension, run by University of Hawaii at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Ing, DrPH (8086921042, clairemt@hawaii.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Environment (time frame: Baseline, 1-year, 2-year, 3-year, 4-year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.