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

April 16, 2026 updated by: University of Hawaii

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:

  1. 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.
  2. 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.
  3. To evaluate the cost and cost-effectiveness of implementing the PPP across community settings.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PILI Pasifika Program - Clinical Setting
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.
Behavioral: PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program
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.
Other Names:
  • PPP
  • PILI Pasifika Program
  • Partnership for Improving Lifestyle Intervention (PILI) + Social Determinants of Health Component
Experimental: PILI Pasifika Program - Community (Non-Clinical) Setting
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.
Behavioral: PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program
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.
Other Names:
  • PPP
  • PILI Pasifika Program
  • Partnership for Improving Lifestyle Intervention (PILI) + Social Determinants of Health Component

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
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.
Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
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).
Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
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).
Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
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.
Assessment data will be collected at baseline and 3-month follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary Questionnaire
Time Frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
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.
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.
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.
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.
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.
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.
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.
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.
An 11-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.
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.
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.
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.
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.
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.
A 5-item measure to assess medical healthcare access and utilization, source of care, insurance coverage, cost-related delays, provider availability, and health literacy.
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.
A 3-item measure to assess barriers to dental care.
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.
A 4-item measure to assess housing situation.
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.
A 4-item measure to assess transportation access and neighborhood environment.
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.
A 4-item measure to assess psychosocial well-being, social connectedness, perceived stress, and perceived safety.
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.
An 18-item measure to assess health literacy.
Assessment data will be collected at baseline and 3-month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hawaii

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Association of Pasifika Organizations
Papa Ola Lōkahi

Investigators

  • Principal Investigator: Nia Aitaoto, PhD, National Association of Pasifika Organizations
  • Principal Investigator: Joseph K Kaholokula, PhD, University of Hawaii, Department of Native Hawaiian Health
  • Principal Investigator: Sheri-Ann Daniels, EdD, Papa Ola Lokahi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

September 15, 2028

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Peau o le Vasa Phase II
  • OT2HL158287 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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