Cardiometabolic ConditionsNCT07387393

To Test the Effectiveness and Implementation Approach of a 3-month PILI Pasifika Program Lifestyle Program With Components of Social Determinants of Health Activities in Real-world Settings (Clinical and Non-clinical Settings) Across 3 Years

A study testing PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program in people with Cardiometabolic Conditions and Hypertension (HTN), run by University of Hawaii at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiometabolic Conditions, Hypertension (HTN), Dyslipidemia
What is being tested?: PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 2 sitesUnited States
Study dates: 1 May 2026to 31 Oct 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
No healthy volunteers
Adult, Older adult

Who may be able to join

Self-identify as Native Hawaiian or Pacific Islander
18 years of age or older
Have at least one of the following self-reported cardiometabolic conditions (Overweight or obesity defined as BMI ≥ 25, pre-diabetes or diabetes, high blood pressure, and/or high cholesterol)
Able to do a moderate level of physical activity or exercise

Who cannot join

Do not identify as Native Hawaiian or Pacific Islander
Under 18 years of age
Currently a student
Do not have any of the following conditions (overweight/obesity, pre-diabetes/diabetes, high blood pressure, or high cholesterol)
Have special dietary needs/dietary restrictions (due to cultural reasons and/or told by a healthcare provider)
Pregnant women
Have physical activity limitations/restrictions (told by a healthcare provider)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites

National Association of Pasifika Organizations
Fayetteville, Arkansas, 72704
Papa Ola Lokahi
Honolulu, Hawaii, 96813

Other trials in United States

About this study

Official title: Peau o le Vasa: Accelerating the Currents of Health Advances for Pasifika People

In this study, the investigators are conducting a Type 3 hybrid effectiveness-implementation trial to evaluate the implementation of the Community Health Workers (CHW)-delivered PILI Pasifika Program (PPP) across 3 regions, the U.S. Affiliated Pacific Islands (USAPI), the continental U.S., and Hawai'i, among 400 Native Hawaiian and Pacific Islander (NHPI) participants in two settings, (clinical and non-clinical) over a 3-year period. The PPP is a 3-month lifestyle intervention that includes a Social Determinants of Health (SDOH) component and was NHPI-adapted from the Diabetes Prevention Program's Lifestyle Program, renamed to the PILI Lifestyle Program (PLP), which demonstrated effectiveness in improving weight, blood pressure, physical activity, and diet among NHPIs. The PPP consists of 8 lifestyle lessons and 4 SDOH activities delivered over a 3-month period.

The aims of this study are threefold:

To evaluate the implementation of the PPP across multiple community sites using a Type 3 hybrid effectiveness-implementation design guided by established frameworks such as RE-AIM and PRISM.
To examine participant-level outcomes associated with PPP implementation, including changes in cardiometabolic risk factors, health behaviors, and SDOH factors from baseline to 3 and 9-month follow-up.
To evaluate the cost and cost-effectiveness of implementing the PPP across community settings.

Read the detailed description

Native Hawaiians and Pacific Islanders (NHPIs) continue to disproportionally experience high rates of cardiometabolic conditions, including obesity, hypertension, type 2 diabetes, and cardiovascular disease. To address these inequities, the Diabetes Prevention Program's Lifestyle Intervention (DPP-LI) was developed and subsequently culturally and contextually adapted into the PILI Lifestyle Program (PLP). Through consolidation and collaboration with NHPIs to revamp the DPP-LI, the original 16 lessons were modified into 8 lessons delivered over a 3-month period. These lessons offer empirically supported strategies, based on the Social Cognitive Theory, to improve healthy eating, physical activity, and time and stress management.

Community Health Workers (CHWs) serve as frontline public health workers and trusted community resources who can effectively disseminate and implement cardiometabolic-related interventions across diverse settings. The trusting relationship CHWs have with communities enables them to serve as a liaison and intermediaries between health, social, and cultural services and the community, facilitating access to services and improving their quality and cultural competence. NHPI CHWs are uniquely positioned to deliver effective interventions that improve cardiometabolic health outcomes and address their social determinants.

The PLP was adapted to include a Social Determinants of Health (SDOH) component and evaluated for its effectiveness in ClinicalTrials NCT06471595, resulting in what is now known as the PILI Pasifika Program (PPP).

Conditions: Cardiometabolic Conditions, Hypertension (HTN), Dyslipidemia, Pre-diabetes, Type 2 Diabetes Mellitus (T2DM), Overweight (BMI > 25)
Being tested: PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program
Keywords: Weight Loss Intervention, CHWs, Community Health Workers, PILI Lifestyle Program, Social Determinants of Health, U.S. Pacific Jurisdictions, Continental U.S., Pacific Islands, Hawai'i, Education, Lifestyle Intervention, Community-Based Participatory Research (CBPR), Academic and Community Partnership, Native Hawaiians, Pacific Islanders, PILI Pasifika Program, PPP
Medical subject headings: Hypertension, Dyslipidemias, Glucose Intolerance, Diabetes Mellitus, Type 2, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PILI (Partnership for Improving Lifestyle Intervention) Pasifika ProgramBehavioural
Also called PPP, PILI Pasifika Program, Partnership for Improving Lifestyle Intervention (PILI) + Social Determinants of Health Component
The PILI Pasifika Program (PPP) is an adapted 3-month behavioral lifestyle intervention with an enhanced social determinants of health (SDOH) component focused on initiating weight loss and addressing social and cultural challenges, such as access to healthy foods, housing, and employment issues, among Native Hawaiians and Pacific Islanders (NHPIs). The 3-month PPP includes 8 lessons that offer empirically supported strategies (e.g., plate method, stimulus control), grounded in Social Cognitive Theory, to improve healthy eating, physical activity, and time and stress management, as well as 4 SDOH activities that guide community needs, such as food access, transportation, and housing throughout the program.

Study groups in NCT07387393
Study group	Role	What they receive
PILI Pasifika Program - Clinical Setting	Experimental	Participants in this group will engage in a 3-month PILI Pasifika Program (PPP) with a trained Community Health Worker (CHW). Each week during the 3-months, participants will meet for approximately 1-1.5 hours to receive a Weekly Lesson or engage in an SDOH activity. Participants will also complete an assessment at baseline, at the 3-month program completion, and at the 9-month follow-up. Receives: Behavioral: PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program
PILI Pasifika Program - Community (Non-Clinical) Setting	Experimental	Participants in this group will engage in a 3-month PILI Pasifika Program (PPP) with a trained Community Health Worker (CHW). Each week during the 3-months, participants will meet for approximately 1-1.5 hours to receive a Weekly Lesson or engage in an SDOH activity. Participants will also complete an assessment at baseline, at the 3-month program completion, and at the 9-month follow-up. Receives: Behavioral: PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemoglobin A1C
A finger stick sample will be collected to measure hemoglobin A1C using the A1CNow+ kit.
Measured: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Lipid Panel
A fingerstick sample will be collected to measure Total Cholesterol, High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides using the CardioChek Plus Analyzer.
Measured: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Blood Pressure
Systolic and diastolic blood pressure will both be measured by a digital blood pressure monitor device (Omron HEM-907XL IntelliSense).
Measured: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Weight
Weight will be calculated using a standardized mobile medical flat scale (Seca 876).
Measured: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Body Mass Index (BMI)
Height data will be measured at baseline using a standardized portable stadiometer. Weight will be measured using a standardized mobile medical flat scale. BMI will be calculated.
Measured: Assessment data will be collected at baseline and 3-month follow-up.

Secondary outcomes (13)

Dietary Questionnaire
A 5-item will be used to estimate the frequency and types of food a participant consumed in the past month. Taken directly from Common Survey IV, the dietary questionnaire consists of 5 items, documenting how many times per week in the past month participants have consumed specific types of food. The responses range from Never, 1-2 times per week, 3-4 times per week, 5-6 times per week, More than 6 times per week, and Don't know.
Measured: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Brief Physical Activity Questionnaire
A 2-item physical activity questionnaire will be used to briefly assess average physical activity behavior per week and the duration of the physical activity.
Measured: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Food Literacy Form
An 11-item questionnaire on food literacy will be used to ask participants' food literacy in regard to planning, managing, selecting, preparing, and eating healthy foods. 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: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Well-Being Questionnaire
A 6-item questionnaire used to briefly assess satisfaction of well-being in standard of living, health, past and present achievements in life, personal relationships, safety, and feeling of belonging.
Measured: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Food Insecurity Form
A 7-item questionnaire on food literacy will be used to assess participants' food literacy in regard to planning, managing, selecting, preparing, and eating healthy foods. 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: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Food Access Form
An 11-item food access questionnaire will be used to assess household food access and the frequency with which households experience food-related challenges. Responses of "All the time (every day)", "Pretty often (3-6x per week)", "Once in a while (1-2x per week)", "Hardly at all (<1x per week)", and "Never". Higher scores indicate lower levels of food access.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Food Access SDOH Form
A 5-item form on food access will be used to assess household food access over the past 12 months, including food availability, affordability, and ability to obtain balanced meals.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Medical Care Access SDOH Form
A 5-item measure to assess medical healthcare access and utilization, source of care, insurance coverage, cost-related delays, provider availability, and health literacy.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Dental Care SDOH Form
A 3-item measure to assess barriers to dental care.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Housing SDOH Form
A 4-item measure to assess housing situation.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Transportation and Environment SDOH Form
A 4-item measure to assess transportation access and neighborhood environment.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Social and Emotional Health SDOH Form
A 4-item measure to assess psychosocial well-being, social connectedness, perceived stress, and perceived safety.
Measured: Assessment data will be collected at baseline and 3-month follow-up.
Health Literacy SDOH Form
An 18-item measure to assess health literacy.
Measured: Assessment data will be collected at baseline and 3-month follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202631 Oct 2028

First posted4 Feb 2026
Study start1 May 2026
Primary completion15 Sep 2028 (estimated)
Study completion31 Oct 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (40)Papers the sponsor has linked to this study.
Other trials for Cardiometabolic ConditionsStudies 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: Non-randomised
Intervention model: Parallel groups
Model description: A multisite, non-randomized, pragmatic implementation trial.
Masking: None (open label)
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07387393
Sponsor's protocol ID: Peau o le Vasa Phase II
Other IDs: OT2HL158287
Status last verified: Apr 2026
First submitted: 27 Jan 2026
Last updated: 9 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013 Dec 1;8:139. doi: 10.1186/1748-5908-8-139.
PubMed 24289295
Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1.
PubMed 25889199
Waltz TJ, Powell BJ, Matthieu MM, Damschroder LJ, Chinman MJ, Smith JL, Proctor EK, Kirchner JE. Use of concept mapping to characterize relationships among implementation strategies and assess their feasibility and importance: results from the Expert Recommendations for Implementing Change (ERIC) study. Implement Sci. 2015 Aug 7;10:109. doi: 10.1186/s13012-015-0295-0.
PubMed 26249843
Kaholokula JK, Look M, Mabellos T, Ahn HJ, Choi SY, Sinclair KA, Wills TA, Seto TB, de Silva M. A Cultural Dance Program Improves Hypertension Control and Cardiovascular Disease Risk in Native Hawaiians: A Randomized Controlled Trial. Ann Behav Med. 2021 Oct 4;55(10):1006-1018. doi: 10.1093/abm/kaaa127.
PubMed 33677520
DePue JD, Dunsiger S, Seiden AD, Blume J, Rosen RK, Goldstein MG, Nu'usolia O, Tuitele J, McGarvey ST. Nurse-community health worker team improves diabetes care in American Samoa: results of a randomized controlled trial. Diabetes Care. 2013 Jul;36(7):1947-53. doi: 10.2337/dc12-1969. Epub 2013 Feb 7.
PubMed 23393217
Rouquette A, Falissard B. Sample size requirements for the internal validation of psychiatric scales. Int J Methods Psychiatr Res. 2011 Dec;20(4):235-49. doi: 10.1002/mpr.352. Epub 2011 Oct 24.
PubMed 22020761
Kwan BM, McGinnes HL, Ory MG, Estabrooks PA, Waxmonsky JA, Glasgow RE. RE-AIM in the Real World: Use of the RE-AIM Framework for Program Planning and Evaluation in Clinical and Community Settings. Front Public Health. 2019 Nov 22;7:345. doi: 10.3389/fpubh.2019.00345. eCollection 2019.
PubMed 31824911
Gupta N, Verma R, Dhiman RK, Rajsekhar K, Prinja S. Cost-Effectiveness Analysis and Decision Modelling: A Tutorial for Clinicians. J Clin Exp Hepatol. 2020 Mar-Apr;10(2):177-184. doi: 10.1016/j.jceh.2019.11.001. Epub 2019 Nov 26.
PubMed 32189934
Narcisse MR, Felix H, Long CR, Hudson T, Payakachat N, Bursac Z, McElfish PA. Frequency and predictors of health services use by Native Hawaiians and Pacific Islanders: evidence from the U.S. National Health Interview Survey. BMC Health Serv Res. 2018 Jul 21;18(1):575. doi: 10.1186/s12913-018-3368-3.
PubMed 30031403
Panapasa SV, Mau MK, Williams DR, McNally JW. Mortality patterns of Native Hawaiians across their lifespan: 1990-2000. Am J Public Health. 2010 Nov;100(11):2304-10. doi: 10.2105/AJPH.2009.183541. Epub 2010 Sep 23.
PubMed 20864716
Palafox NA, Reichhardt M, Taitano JR, Nitta M, Garstang H, Riklon S, Taulung L, Buenconsejo-Lum LE. A Socio-Ecological Framework for Cancer Control in the Pacific: A Community Case Study of the US Affiliated Pacific Island Jurisdictions 1997-2017. Front Public Health. 2018 Nov 13;6:313. doi: 10.3389/fpubh.2018.00313. eCollection 2018.
PubMed 30483488
Wu Y, Braun K, Onaka AT, Horiuchi BY, Tottori CJ, Wilkens L. Life Expectancies in Hawai'i: A Multi-ethnic Analysis of 2010 Life Tables. Hawaii J Med Public Health. 2017 Jan;76(1):9-14.
PubMed 28090398
Nakagawa K, Koenig MA, Seto TB, Asai SM, Chang CW. Racial disparities among Native Hawaiians and Pacific Islanders with intracerebral hemorrhage. Neurology. 2012 Aug 14;79(7):675-80. doi: 10.1212/WNL.0b013e3182608c6f. Epub 2012 Jul 18.
PubMed 22815551
McElfish PA, Purvis RS, Esquivel MK, Sinclair KA, Townsend C, Hawley NL, Haggard-Duff LK, Kaholokula JK. Diabetes Disparities and Promising Interventions to Address Diabetes in Native Hawaiian and Pacific Islander Populations. Curr Diab Rep. 2019 Mar 18;19(5):19. doi: 10.1007/s11892-019-1138-1.
PubMed 30887399
Mau MK, Keawe'aimoku Kaholokula J, West MR, Leake A, Efird JT, Rose C, Palakiko DM, Yoshimura S, Kekauoha PB, Gomes H. Translating diabetes prevention into native Hawaiian and Pacific Islander communities: the PILI 'Ohana Pilot project. Prog Community Health Partnersh. 2010 Spring;4(1):7-16. doi: 10.1353/cpr.0.0111.
PubMed 20364073

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
Not yet recruitingPhase 4
Comparing Different Medication Regimens to Maintaining Weight Loss Among Adults With Obesity Using GLP-1s
Obesity & Overweight, Cardiometabolic Health Indicators
Recruiting
The Sleep2BWell Trial
Blood Pressure, Sleep Health
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Active, not recruiting
E-Bike Commuting and Health in Overweight College Students
Obesity &Amp; Overweight, Sedentary Behaviors

All Cardiometabolic Conditions trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Peau o le Vasa: Accelerating the Currents of Health Advances for Pasifika People
ClinicalTrials.gov ID: NCT07387393
Acronym / sponsor ID: Peau o le Vasa Phase II
Conditions: Cardiometabolic Conditions, Hypertension (HTN), Dyslipidemia, Pre-diabetes, Type 2 Diabetes Mellitus (T2DM), Overweight (BMI > 25)
Keywords: Weight Loss Intervention, CHWs, Community Health Workers, PILI Lifestyle Program, Social Determinants of Health, U.S. Pacific Jurisdictions, Continental U.S., Pacific Islands
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 400 participants (estimated)
Lead sponsor: University of HawaiiUniversity, hospital or other
Collaborators: National Association of Pasifika Organizations, Papa Ola Lōkahi, National Heart, Lung, and Blood Institute (NHLBI)
Study start: 1 May 2026 (actual)
Primary completion: 15 Sep 2028 (estimated)
Study completion: 31 Oct 2028 (estimated)
First posted: 4 Feb 2026 (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.

The aims of this study are threefold:

To evaluate the implementation of the PPP across multiple community sites using a Type 3 hybrid effectiveness-implementation design guided by established frameworks such as RE-AIM and PRISM.
To examine participant-level outcomes associated with PPP implementation, including changes in cardiometabolic risk factors, health behaviors, and SDOH factors from baseline to 3 and 9-month follow-up.
To evaluate the cost and cost-effectiveness of implementing the PPP across community settings.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: A multisite, non-randomized, pragmatic implementation trial.

Arm	Type	Receives
PILI Pasifika Program - Clinical Setting	Experimental	Behavioral: PILI (Partnership for Improving Lifestyle Intervention) Pasifika ProgramParticipants in this group will engage in a 3-month PILI Pasifika Program (PPP) with a trained Community Health Worker (CHW). Each week during the 3-months, participants will meet for approximately 1-1.5 hours to receive a Weekly Lesson or engage in an SDOH activity. Participants will also complete an assessment at baseline, at the 3-month program completion, and at the 9-month follow-up.
PILI Pasifika Program - Community (Non-Clinical) Setting	Experimental	Behavioral: PILI (Partnership for Improving Lifestyle Intervention) Pasifika ProgramParticipants in this group will engage in a 3-month PILI Pasifika Program (PPP) with a trained Community Health Worker (CHW). Each week during the 3-months, participants will meet for approximately 1-1.5 hours to receive a Weekly Lesson or engage in an SDOH activity. Participants will also complete an assessment at baseline, at the 3-month program completion, and at the 9-month follow-up.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Self-identify as Native Hawaiian or Pacific Islander
18 years of age or older
Have at least one of the following self-reported cardiometabolic conditions (Overweight or obesity defined as BMI ≥ 25, pre-diabetes or diabetes, high blood pressure, and/or high cholesterol)
Able to do a moderate level of physical activity or exercise

Key exclusion criteria (7 listed)

Do not identify as Native Hawaiian or Pacific Islander
Under 18 years of age
Currently a student
Do not have any of the following conditions (overweight/obesity, pre-diabetes/diabetes, high blood pressure, or high cholesterol)
Have special dietary needs/dietary restrictions (due to cultural reasons and/or told by a healthcare provider)

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
PILI (Partnership for Improving Lifestyle Intervention) Pasifika ProgramAlso: PPP, PILI Pasifika Program, Partnership for Improving Lifestyle Intervention (PILI) + Social Determinants of Health ComponentThe PILI Pasifika Program (PPP) is an adapted 3-month behavioral lifestyle intervention with an enhanced social determinants of health (SDOH) component focused on initiating weight loss and addressing social and cultural challenges, such as access to healthy foods, housing, and employment issues, among Native Hawaiians and Pacific Islanders (NHPIs). The 3-month PPP includes 8 lessons that offer empirically supported strategies (e.g., plate method, stimulus control), grounded in Social Cognitive Theory, to improve healthy eating, physical activity, and time and stress management, as well as 4 SDOH activities that guide community needs, such as food access, transportation, and housing throughout the program.	Behavioural	PILI Pasifika Program - Clinical Setting, PILI Pasifika Program - Community (Non-Clinical) Setting

Primary outcome

Hemoglobin A1C
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
A finger stick sample will be collected to measure hemoglobin A1C using the A1CNow+ kit.
Lipid Panel
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
A fingerstick sample will be collected to measure Total Cholesterol, High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides using the CardioChek Plus Analyzer.
Blood Pressure
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Systolic and diastolic blood pressure will both be measured by a digital blood pressure monitor device (Omron HEM-907XL IntelliSense).
Weight
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Weight will be calculated using a standardized mobile medical flat scale (Seca 876).
Body Mass Index (BMI)
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Height data will be measured at baseline using a standardized portable stadiometer. Weight will be measured using a standardized mobile medical flat scale. BMI will be calculated.

13 secondary outcomes

Dietary Questionnaire
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Brief Physical Activity Questionnaire
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Food Literacy Form
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Well-Being Questionnaire
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Food Insecurity Form
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Food Access Form
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Food Access SDOH Form
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Medical Care Access SDOH Form
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Dental Care SDOH Form
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Housing SDOH Form
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Transportation and Environment SDOH Form
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Social and Emotional Health SDOH Form
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Health Literacy SDOH Form
Time frame: Assessment data will be collected at baseline and 3-month follow-up.

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 9 Jun 2026.
Background: PubMed 24289295Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013 Dec 1;8:139. doi: 10.1186/1748-5908-8-139.
Background: PubMed 25889199Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1.
Background: PubMed 26249843Waltz TJ, Powell BJ, Matthieu MM, Damschroder LJ, Chinman MJ, Smith JL, Proctor EK, Kirchner JE. Use of concept mapping to characterize relationships among implementation strategies and assess their feasibility and importance: results from the Expert Recommendations for Implementing Change (ERIC) study. Implement Sci. 2015 Aug 7;10:109. doi: 10.1186/s13012-015-0295-0.
Background: PubMed 33677520Kaholokula JK, Look M, Mabellos T, Ahn HJ, Choi SY, Sinclair KA, Wills TA, Seto TB, de Silva M. A Cultural Dance Program Improves Hypertension Control and Cardiovascular Disease Risk in Native Hawaiians: A Randomized Controlled Trial. Ann Behav Med. 2021 Oct 4;55(10):1006-1018. doi: 10.1093/abm/kaaa127.
Background: PubMed 23393217DePue JD, Dunsiger S, Seiden AD, Blume J, Rosen RK, Goldstein MG, Nu'usolia O, Tuitele J, McGarvey ST. Nurse-community health worker team improves diabetes care in American Samoa: results of a randomized controlled trial. Diabetes Care. 2013 Jul;36(7):1947-53. doi: 10.2337/dc12-1969. Epub 2013 Feb 7.
Background: PubMed 22020761Rouquette A, Falissard B. Sample size requirements for the internal validation of psychiatric scales. Int J Methods Psychiatr Res. 2011 Dec;20(4):235-49. doi: 10.1002/mpr.352. Epub 2011 Oct 24.
Background: PubMed 31824911Kwan BM, McGinnes HL, Ory MG, Estabrooks PA, Waxmonsky JA, Glasgow RE. RE-AIM in the Real World: Use of the RE-AIM Framework for Program Planning and Evaluation in Clinical and Community Settings. Front Public Health. 2019 Nov 22;7:345. doi: 10.3389/fpubh.2019.00345. eCollection 2019.
Background: PubMed 32189934Gupta N, Verma R, Dhiman RK, Rajsekhar K, Prinja S. Cost-Effectiveness Analysis and Decision Modelling: A Tutorial for Clinicians. J Clin Exp Hepatol. 2020 Mar-Apr;10(2):177-184. doi: 10.1016/j.jceh.2019.11.001. Epub 2019 Nov 26.
Background: PubMed 30031403Narcisse MR, Felix H, Long CR, Hudson T, Payakachat N, Bursac Z, McElfish PA. Frequency and predictors of health services use by Native Hawaiians and Pacific Islanders: evidence from the U.S. National Health Interview Survey. BMC Health Serv Res. 2018 Jul 21;18(1):575. doi: 10.1186/s12913-018-3368-3.
Background: PubMed 20864716Panapasa SV, Mau MK, Williams DR, McNally JW. Mortality patterns of Native Hawaiians across their lifespan: 1990-2000. Am J Public Health. 2010 Nov;100(11):2304-10. doi: 10.2105/AJPH.2009.183541. Epub 2010 Sep 23.
Background: PubMed 30483488Palafox NA, Reichhardt M, Taitano JR, Nitta M, Garstang H, Riklon S, Taulung L, Buenconsejo-Lum LE. A Socio-Ecological Framework for Cancer Control in the Pacific: A Community Case Study of the US Affiliated Pacific Island Jurisdictions 1997-2017. Front Public Health. 2018 Nov 13;6:313. doi: 10.3389/fpubh.2018.00313. eCollection 2018.
Background: PubMed 28090398Wu Y, Braun K, Onaka AT, Horiuchi BY, Tottori CJ, Wilkens L. Life Expectancies in Hawai'i: A Multi-ethnic Analysis of 2010 Life Tables. Hawaii J Med Public Health. 2017 Jan;76(1):9-14.

Related trials for Cardiometabolic Conditions

RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
Not yet recruitingPhase 4
Comparing Different Medication Regimens to Maintaining Weight Loss Among Adults With Obesity Using GLP-1s
Obesity & Overweight, Cardiometabolic Health Indicators
Recruiting
The Sleep2BWell Trial
Blood Pressure, Sleep Health
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Active, not recruiting
E-Bike Commuting and Health in Overweight College Students
Obesity &Amp; Overweight, Sedentary Behaviors

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.

Joseph K Kaholokula, PhD principal investigator

University of Hawaii, Department of Native Hawaiian Health

Nia Aitaoto, PhD principal investigator

National Association of Pasifika Organizations

Sheri-Ann Daniels, EdD principal investigator

Papa Ola Lokahi

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 9 Jun 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin A1C (time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07387393, which also lists 40 linked publications.

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 9 Jun 2026.