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

NCT07387393 | Enrolling By Invitation

• 2 other identifiers: Peau o le Vasa Phase IIOT2HL158287
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cardiometabolic Conditions; Dyslipidemia; Pre-diabetes; Type 2 Diabetes Mellitus (T2DM); Overweight (BMI > 25); Weight Loss Trial; Hypertension (HTN)

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

Outcome Measures

Primary Outcomes (5)

• Hemoglobin A1C

  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

  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.

• Blood Pressure

  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.

• Weight

  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.

• 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.

  Assessment data will be collected at baseline and 3-month follow-up.

Secondary Outcomes (13)

• Dietary Questionnaire

  Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.

• Brief Physical Activity Questionnaire

  Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.

• Food Literacy Form

  Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.

• Well-Being Questionnaire

  Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.

• Food Insecurity Form

  Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.

Study Arms (2)

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.

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.

Behavioral: PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program

Interventions

PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program BEHAVIORAL

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.

Also known as: PPP, PILI Pasifika Program, Partnership for Improving Lifestyle Intervention (PILI) + Social Determinants of Health Component

PILI Pasifika Program - Clinical Setting; PILI Pasifika Program - Community (Non-Clinical) Setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identify as Native Hawaiian or Pacific Islander
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Hawaii: lead
• National Association of Pasifika Organizations: collaborator
• Papa Ola Lōkahi: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

National Association of Pasifika Organizations

Fayetteville, Arkansas, 72704, United States

Location

Papa Ola Lokahi

Honolulu, Hawaii, 96813, United States

Location

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MeSH Terms

Conditions

Hypertension; Dyslipidemias; Glucose Intolerance; Diabetes Mellitus, Type 2; Overweight

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Glucose Metabolism Disorders; Diabetes Mellitus; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph K Kaholokula, PhD

  University of Hawaii, Department of Native Hawaiian Health

  PRINCIPAL INVESTIGATOR

• Nia Aitaoto, PhD

  National Association of Pasifika Organizations

  PRINCIPAL INVESTIGATOR

• Sheri-Ann Daniels, EdD

  Papa Ola Lokahi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multisite, non-randomized, pragmatic implementation trial.

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-04

Locations

US (2)