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

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. 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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• National Association of Pasifika Organizations

  collaborator UNKNOWN

• Papa Ola Lōkahi

  collaborator UNKNOWN

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Hawaii

  lead OTHER

Principal Investigators

• Joseph K Kaholokula, PhD · University of Hawaii, Department of Native Hawaiian Health

• Nia Aitaoto, PhD · National Association of Pasifika Organizations

• Sheri-Ann Daniels, EdD · Papa Ola Lokahi

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2028-09-15

Completion

2028-10-31

Countries

• United States

Study Locations