To Test the Effectiveness and Implementation Approach of a 3-month PILI Pasifika Program Lifestyl… (NCT07387393) | Clinical Trial Compass
By InvitationNot Applicable
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
United States400 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is the PILI Pasifika Program specifically designed for Pacific Islander communities and focuses on real-world settings over 3 years, would my doctor think this kind of community-based lifestyle program is a good fit for managing my specific cardiometabolic condition right now?
2This trial is measuring things like my A1C, blood pressure, lipid panel, and BMI — how does my doctor think my current numbers compare to what this type of program is designed to help, and would standard clinical care alone be a better starting point for me?
3The trial runs for 3 years and takes place across both clinical and non-clinical settings — can my doctor help me understand what that time commitment and involvement would actually look like in practice, and whether it's realistic given my current health situation?
4Since the trial is enrolling by invitation rather than open enrollment, can my doctor find out whether I or my family would be eligible to be considered, and who is coordinating referrals into the program?
5This program includes activities around social determinants of health, not just medical treatment — how does my doctor think that broader approach fits alongside any medications or clinical treatments I'm already receiving for conditions like hypertension or pre-diabetes?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hemoglobin A1C
Timeframe: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
2
Lipid Panel
Timeframe: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
3
Blood Pressure
Timeframe: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
4
Weight
Timeframe: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
5
Body Mass Index (BMI)
Timeframe: Assessment data will be collected at baseline and 3-month follow-up.