Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06471595 · ClinicalTrials.gov registry record · NA
Peau o le Vasa: Analysis of the Efficacy and Feasibility of the PILI Lifestyle Program (PLP) + Social Determinants of Health (SDOH) Intervention and Adaptation of SDOH Measures Pilot Study
A NA study, sponsored by University of Hawaii.
- Completed
- Registry status
- NA
- Development phase
- 242
- Enrollment target
NCT06471595 is a NA study that has completed, run by University of Hawaii. The registered enrollment target is 242 participants.
The verdict
NCT06471595, a NA study, has completed, sponsored by University of Hawaii.
- COMPLETED
- Registry status
- NA
- Development phase
- 242 participants
- Enrollment target
Study Summary
Native Hawaiians and Pacific Islanders (NHPIs) are defined as the descendants of the original peoples of Polynesia (e.g., Hawai'i, Sāmoa, and Tonga), Melanesia (e.g., Fiji), and Micronesia (e.g., Guam, Chuuk, and Marshall Islands). Their history with the U.S. parallels that of American Indians and Alaska Natives. Before Western contact, NHPIs had thriving societies with rich cultural traditions. After contact, NHPI communities were decimated to near extinction by infectious diseases, exploited for their cultural and natural resources, displaced from their ancestral lands, forced to assimilate to Western ways, and marginalized through legislative acts and compulsory assimilation policies (i.e., banning native language). The consequences have been high rates of cardiometabolic medical conditions, such as obesity, hypertension, type 2 diabetes, and cardiovascular disease. These medical conditions are, in part, a result of cultural disruptions and displacement that altered the traditional practices of NHPI and led to poor social determinants of health (SDOH). The basic premise of our project is that Community Health Workers (CHWs) can accelerate health equity for NHPI communities by disseminating and implementing culturally responsive, evidence-based interventions to prevent cardiometabolic medical conditions and improve their SDOH. The purpose of this project is to test the potential efficacy of the PILI Lifestyle Program (PLP) with integrated social determinants of health (SDOH) components and have it delivered by NHPI Community Health Workers (CHWs) to NHPIs with cardiometabolic-related conditions in a two-arm pilot randomized controlled trial (RCT) using a waitlist control. The investigators will evaluate the efficacy of the PLP+SDOH in improving the primary outcomes of hemoglobin A1c (HbA1c), systolic blood pressure, cholesterol, and weight in 180 adult NHPIs with pre-diabetes/type 2 diabetes, hypertension, dyslipidemia, and/or overweight/obesity.
Interventions
- BEHAVIORAL Partnership for Improving Lifestyle Intervention (PILI) Lifestyle Program + Social Determinants of Health (SDOH) Component
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2024-09-01 |
| Est. Completion | 2025-09-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06471595
The ClinicalTrials.gov registry entry for NCT06471595 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 242 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Hawaii, which has 77 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Partnership for Improving Lifestyle Intervention (PILI) Lifestyle Program + Social Determinants of Health (SDOH) Component is the first listed.
NCT06471595 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06471595 about?
NCT06471595 is a clinical study titled "Peau o le Vasa: Analysis of the Efficacy and Feasibility of the PILI Lifestyle Program (PLP) + Social Determinants of Health (SDOH) Intervention and Adaptation of SDOH Measures Pilot Study". Native Hawaiians and Pacific Islanders (NHPIs) are defined as the descendants of the original peoples of Polynesia (e.g., Hawai'i, Sāmoa, and Tonga), Melanesia (e.g., Fiji), and Micronesia (e.g., Guam, Chuuk, and Marshall Islands). Their history with the U.S. parallels that of American Indians and A...
What is the current status of trial NCT06471595?
This trial is currently completed. It is a NA study. The enrollment target is 242 participants. The study started on 2024-09-01. Estimated completion is 2025-09-01.
What interventions are being tested in trial NCT06471595?
The interventions under investigation include: Partnership for Improving Lifestyle Intervention (PILI) Lifestyle Program + Social Determinants of Health (SDOH) Component (BEHAVIORAL).
Who is sponsoring clinical trial NCT06471595?
This trial is sponsored by University of Hawaii, which has 77 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.