NCT07387393Enrolling by invitation
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
Peau o le Vasa: Accelerating the Currents of Health Advances for Pasifika People
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 27 Jan 2026
- Start date
- May 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- University of Hawaii
- Diseases
- High blood pressure, Type 2 diabetes
- NCT number
- NCT07387393
What you commit to
- Study type: Interventional
- Planned participants: 400
- From May 2026 to the primary completion date, Sept 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Do not have any of the following conditions (overweight/obesity, pre-diabetes/diabetes, high blood pressure, or high cholesterol)
Age
- Under 18 years of age
Other
- Do not identify as Native Hawaiian or Pacific Islander
- Currently a student
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Association of Pasifika Organizations Coordinator of this site? Confirm its status | Fayetteville | United States | Unknown status |
| Papa Ola Lokahi Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.