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Enrolling by Invitation

NCT Number: NCT07387393

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

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.

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Key information

Conditions

CARDIOMETABOLIC CONDITIONS Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hypertension Hypertension (HTN) Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Overweight (BMI > 25) Pathological Conditions, Signs and Symptoms Pre-diabetes Signs and Symptoms Type 2 Diabetes Mellitus (T2DM) Vascular Diseases Weight Loss Trial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Association of Pasifika Organizations, Fayetteville, Arkansas, United States

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About this study

Native Hawaiians and Pacific Islanders (NHPIs) continue to disproportionally experience high rates of cardiometabolic conditions, including obesity, hypertension, type 2 diabetes, and cardiovascular disease. To address these inequities, the Diabetes Prevention Program's Lifestyle Intervention (DPP-LI) was developed and subsequently culturally and contextually adapted into the PILI Lifestyle Program (PLP). Through consolidation and collaboration with NHPIs to revamp the DPP-LI, the original 16 lessons were modified into 8 lessons delivered over a 3-month period. These lessons offer empirically supported strategies, based on the Social Cognitive Theory, to improve healthy eating, physical activity, and time and stress management.

Community Health Workers (CHWs) serve as frontline public health workers and trusted community resources who can effectively disseminate and implement cardiometabolic-related interventions across diverse settings. The trusting relationship CHWs have with communities enables them to serve as a liaison and intermediaries between health, social, and cultural services and the community, facilitating access to services and improving their quality and cultural competence. NHPI CHWs are uniquely positioned to deliver effective interventions that improve cardiometabolic health outcomes and address their social determinants.

The PLP was adapted to include a Social Determinants of Health (SDOH) component and evaluated for its effectiveness in ClinicalTrials NCT06471595, resulting in what is now known as the PILI Pasifika Program (PPP).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program

Behavioral

The PILI Pasifika Program (PPP) is an adapted 3-month behavioral lifestyle intervention with an enhanced social determinants of health (SDOH) component focused on initiating weight loss and addressing social and cultural challenges, such as access to healthy foods, housing, and employment issues, among Native Hawaiians and Pacific Islanders (NHPIs). The 3-month PPP includes 8 lessons that offer empirically supported strategies (e.g., plate method, stimulus control), grounded in Social Cognitive Theory, to improve healthy eating, physical activity, and time and stress management, as well as 4 SDOH activities that guide community needs, such as food access, transportation, and housing throughout the program.

Other names: PPP, PILI Pasifika Program, Partnership for Improving Lifestyle Intervention (PILI) + Social Determinants of Health Component

Primary outcomes

  1. Hemoglobin A1C

    Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.

    A finger stick sample will be collected to measure hemoglobin A1C using the A1CNow+ kit.

  2. Lipid Panel

    Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.

    A fingerstick sample will be collected to measure Total Cholesterol, High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides using the CardioChek Plus Analyzer.

  3. Blood Pressure

    Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.

    Systolic and diastolic blood pressure will both be measured by a digital blood pressure monitor device (Omron HEM-907XL IntelliSense).

  4. Weight

    Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.

    Weight will be calculated using a standardized mobile medical flat scale (Seca 876).

  5. Body Mass Index (BMI)

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

    Height data will be measured at baseline using a standardized portable stadiometer. Weight will be measured using a standardized mobile medical flat scale. BMI will be calculated.

Secondary outcomes

  1. Dietary Questionnaire

    Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.

    A 5-item will be used to estimate the frequency and types of food a participant consumed in the past month. Taken directly from Common Survey IV, the dietary questionnaire consists of 5 items, documenting how many times per week in the past month participants have consumed specific types of food. The responses range from Never, 1-2 times per week, 3-4 times per week, 5-6 times per week, More than 6 times per week, and Don't know.

  2. Brief Physical Activity Questionnaire

    Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.

    A 2-item physical activity questionnaire will be used to briefly assess average physical activity behavior per week and the duration of the physical activity.

  3. Food Literacy Form

    Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.

    An 11-item questionnaire on food literacy will be used to ask participants' food literacy in regard to planning, managing, selecting, preparing, and eating healthy foods. The responses and scores range from 1-not at all/never, 2-disagree, 3-slightly disagree, 4-slightly agree, 5-yes/always. Higher scores indicate greater food literacy.

  4. Well-Being Questionnaire

    Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.

    A 6-item questionnaire used to briefly assess satisfaction of well-being in standard of living, health, past and present achievements in life, personal relationships, safety, and feeling of belonging.

  5. Food Insecurity Form

    Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.

    A 7-item questionnaire on food literacy will be used to assess participants' food literacy in regard to planning, managing, selecting, preparing, and eating healthy foods. The responses and scores range from 1-not at all/never, 2-disagree, 3-slightly disagree, 4-slightly agree, 5-yes/always. Higher scores indicate greater food literacy.

  6. Food Access Form

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

    An 11-item food access questionnaire will be used to assess household food access and the frequency with which households experience food-related challenges. Responses of "All the time (every day)", "Pretty often (3-6x per week)", "Once in a while (1-2x per week)", "Hardly at all (<1x per week)", and "Never". Higher scores indicate lower levels of food access.

  7. Food Access SDOH Form

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

    A 5-item form on food access will be used to assess household food access over the past 12 months, including food availability, affordability, and ability to obtain balanced meals.

  8. Medical Care Access SDOH Form

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

    A 5-item measure to assess medical healthcare access and utilization, source of care, insurance coverage, cost-related delays, provider availability, and health literacy.

  9. Dental Care SDOH Form

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

    A 3-item measure to assess barriers to dental care.

  10. Housing SDOH Form

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

    A 4-item measure to assess housing situation.

  11. Transportation and Environment SDOH Form

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

    A 4-item measure to assess transportation access and neighborhood environment.

  12. Social and Emotional Health SDOH Form

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

    A 4-item measure to assess psychosocial well-being, social connectedness, perceived stress, and perceived safety.

  13. Health Literacy SDOH Form

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

    An 18-item measure to assess health literacy.

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • National Association of Pasifika Organizations
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Papa Ola Lōkahi

Registry information

Official study title

Peau o le Vasa: Accelerating the Currents of Health Advances for Pasifika People

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 4, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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