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

Enrolling by invitation · Not applicable

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

In brief

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.

Key facts

Study ID

NCT07387393

Run by

University of Hawaii

People needed

400

Starts

2026-05-01

Expected to finish

2028-10-31

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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)

Where it is running

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

Full record on ClinicalTrials.gov

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