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

Completed · Not applicable

Conditions studied: Weight Loss Trial, Cardiometabolic Syndrome, Hypertension, Dyslipidemia, Pre-diabetes, Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID: NCT06471595
Run by: University of Hawaii
People needed: 242
Starts: 2024-09-01
Expected to finish: 2025-09-01
Last updated by the study team: 2025-10-27

Who can join

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

You may qualify if…

NHPI participants over 18 years of age with a self-reported (e.g., Have you been told by a physician that you have diabetes?) cardiometabolic condition (i.e., pre-diabetes/T2D, HTN, dyslipidemia, and/or overweight/obesity [BMI ≥ 25])

You may not qualify if…

Not NHPI, NHPI participants under 18 years of age, and without a self-reported (e.g., Have you been told by a physician that you have diabetes?) cardiometabolic condition (i.e., pre-diabetes/T2D, HTN, dyslipidemia, and/or overweight/obesity [BMI ≥ 25])

Where it is running

National Association Of Pasifika Organizations — Fayetteville, Arkansas, United States
Arkansas Coalition of Marshallese — Springdale, Arkansas, United States
Papa Ola Lokahi — Honolulu, Hawaii, United States
Ke Ola Mamo — Honolulu, Hawaii, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.