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

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
University of Hawaii
Study ID
NCT07387393
Status
Enrolling By Invitation

Conditions

  • Cardiometabolic Conditions
  • Dyslipidemia
  • Hypertension (HTN)
  • Overweight (BMI > 25)
  • Pre-diabetes
  • Type 2 Diabetes Mellitus (T2DM)
  • Weight Loss Trial

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Sep 15, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PILI Pasifika Program - Clinical Setting
    Participants in this group will engage in a 3-month PILI Pasifika Program (PPP) with a trained Community Health Worker (CHW). Each week during the 3-months, participants will meet for approximately 1-1.5 hours to receive a Weekly Lesson or engage in an SDOH activity. Participants will also complete an assessment at baseline, at the 3-month program completion, and at the 9-month follow-up.
  • Experimental: PILI Pasifika Program - Community (Non-Clinical) Setting
    Participants in this group will engage in a 3-month PILI Pasifika Program (PPP) with a trained Community Health Worker (CHW). Each week during the 3-months, participants will meet for approximately 1-1.5 hours to receive a Weekly Lesson or engage in an SDOH activity. Participants will also complete an assessment at baseline, at the 3-month program completion, and at the 9-month follow-up.

Primary Outcome Measure

Hemoglobin A1C [ Time Frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up. ]

Locations (2)

FacilityCityStateZIPSite coordinators
National Association of Pasifika OrganizationsFayettevilleArkansas72704-
Papa Ola LokahiHonoluluHawaii96813-

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By research site
National Association of Pasifika Organizations· Fayetteville, ARPapa Ola Lokahi· Honolulu, HI

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