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

NCT06471595 | Completed

• 2 other identifiers: Peau o le Vasa Phase 1OT2HL158287
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Weight loss intervention; CHWs; Community Health Workers; PILI Lifestyle Program; Curriculum; Social Determinants of Health (SDoH); U.S. Pacific Jurisdictions; Continental U.S.; Pacific; Hawai'i; Economic stability; Physical and Neighborhood Environment; Education; Food; Community and Social Context; Health Care System

Outcome Measures

Primary Outcomes (5)

• Hemoglobin A1c

  Hemoglobin A1c data will be collected using the A1cNow+ kit.

  Assessment data will be collected at baseline and 3-month follow-up.

• Blood Cholesterol

  Blood cholesterol measures will be obtained from a finger stick using the Cardiocheck Plus Analyzer. Total cholesterol, HDL, and LDL data will be collected.

  Assessment data will be collected at baseline and 3-month follow-up.

• Blood pressure

  Systolic and diastolic blood pressure will be measured by a digital blood pressure monitor device.

  Assessment data will be collected at baseline and 3-month follow up.

• Height

  Height data will be collected using a standardized portable stadiometer.

  Assessment data are collected at baseline.

• Weight

  Weight will be calculated using a standardized mobile medical flat scale.

  Assessment data will be collected at baseline and 3-month follow-up.

Secondary Outcomes (12)

• Dietary Questionnaire

  Assessment data will be collected at baseline and 3-month follow-up.

• Brief Physical Activity Questionnaire

  Assessment data will be collected at baseline and 3-month follow-up.

• Well-Being Questionnaire

  Assessment data will be collected at baseline and 3-month follow-up.

• Access to Health Care and Social Needs Form

  Assessment data will be collected at baseline and 3-month follow-up.

• Household Food Patterns Form

  Assessment data will be collected at baseline and 3-month follow-up.

Study Arms (2)

Intervention Group - PLP + SDoH

EXPERIMENTAL

Participants randomized to the Intervention Group will be engaged in a 3-month randomized controlled trial and receive the PLP+SDoH curriculum from a trained Community Health Worker (CHW). Each week during the 3 months, participants will meet for approximately 1-1.5 hours and be taught a PLP Lesson or engage in an SDoH activity. Participants will also be asked to undergo an assessment collection point at baseline recruitment and 3-month completion time.

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

Waitlist Control Group

NO INTERVENTION

Participants randomized to the Waitlist Control Group will receive nothing from the research group while the Intervention Group is underway. Participants will be asked to undergo an assessment collection point at baseline recruitment and 3-month completion time. After the Control Group's 3-month follow-up assessment, they will be offered the PLP+SDoH curriculum.

Interventions

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

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.

Intervention Group - PLP + SDoH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 \[BMI ≥ 25\])

Sponsors & Collaborators

• University of Hawaii: lead
• National Association of Pasifika Organizations: collaborator
• Papa Ola Lōkahi: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

National Association Of Pasifika Organizations

Fayetteville, Arkansas, 72704, United States

Location

Arkansas Coalition of Marshallese

Springdale, Arkansas, 72764, United States

Location

Papa Ola Lokahi

Honolulu, Hawaii, 96813, United States

Location

Ke Ola Mamo

Honolulu, Hawaii, 96817, United States

Location

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MeSH Terms

Conditions

Metabolic Syndrome; Hypertension; Dyslipidemias; Glucose Intolerance; Diabetes Mellitus, Type 2

Interventions

Social Determinants of Health; Elements

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Hyperglycemia; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Population Characteristics; Health; Inorganic Chemicals

Study Officials

• Joseph K Kaholokula, PhD

  University of Hawaii

  PRINCIPAL INVESTIGATOR

• Sheri Daniels, PhD

  Papa Ola Lokahi

  PRINCIPAL INVESTIGATOR

• Nia Aitaoto, PhD

  National Association of Pasifika Organizations

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm randomized controlled trial (RCT).

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 27, 2025

Record last verified: 2024-12

Locations

US (4)