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

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.

Conditions

• Weight Loss Trial
• Cardiometabolic Syndrome
• Hypertension
• Dyslipidemia
• Pre-diabetes
• Type 2 Diabetes Mellitus

Interventions

BEHAVIORAL

Partnership for Improving Lifestyle Intervention (PILI) Lifestyle Program + Social Determinants of Health (SDOH) Component

The PILI Lifestyle Program (PLP) is an adapted 3-month behavioral lifestyle intervention focused on addressing and initiating weight loss in Native Hawaiians and Pacific Islanders (NHPIs). The PLP covers 8 lessons that offer empirically supported strategies (e.g., plate method, stimulus control) based on the social cognitive theory to improve healthy eating, physical activity, and time and stress management across the 3 months. In this study, the PLP will be enhanced with social determinants of health (SDOH) components that address challenges such as access to healthy foods, housing, and employment issues. There will be 4 SDOH activities relevant to participants' needs and lives. These activities will be delivered during the 3-month PLP.

Sponsors & Collaborators

• National Association of Pasifika Organizations

  collaborator UNKNOWN

• Papa Ola Lōkahi

  collaborator UNKNOWN

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Hawaii

  lead OTHER

Principal Investigators

• Joseph K Kaholokula, PhD · University of Hawaii

• Sheri Daniels, PhD · Papa Ola Lokahi

• Nia Aitaoto, PhD · National Association of Pasifika Organizations

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2025-09-01

Completion

2025-09-01

Countries

• United States

Study Locations