An interventional study of PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program in Cardiometabolic Conditions, Hypertension (HTN) and Dyslipidemia, sponsored by University of Hawaii. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by University of Hawaii · Not applicable, Interventional, and Treatment
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:
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).
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 400 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Hawaii is the lead sponsor of 97 studies on the registry; 21 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program
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.
Behavioral: PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program
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.
Also known as: PPP, PILI Pasifika Program, Partnership for Improving Lifestyle Intervention (PILI) + Social Determinants of Health Component
Hemoglobin A1C
A finger stick sample will be collected to measure hemoglobin A1C using the A1CNow+ kit.
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Lipid Panel
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.
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Blood Pressure
Systolic and diastolic blood pressure will both be measured by a digital blood pressure monitor device (Omron HEM-907XL IntelliSense).
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Weight
Weight will be calculated using a standardized mobile medical flat scale (Seca 876).
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Body Mass Index (BMI)
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.
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Dietary Questionnaire
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.
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Brief Physical Activity Questionnaire
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.
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Food Literacy Form
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.
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Well-Being Questionnaire
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.
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Food Insecurity Form
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.
Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.
Food Access Form
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.
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Food Access SDOH Form
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.
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Medical Care Access SDOH Form
A 5-item measure to assess medical healthcare access and utilization, source of care, insurance coverage, cost-related delays, provider availability, and health literacy.
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Dental Care SDOH Form
A 3-item measure to assess barriers to dental care.
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Housing SDOH Form
A 4-item measure to assess housing situation.
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Transportation and Environment SDOH Form
A 4-item measure to assess transportation access and neighborhood environment.
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Social and Emotional Health SDOH Form
A 4-item measure to assess psychosocial well-being, social connectedness, perceived stress, and perceived safety.
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Health Literacy SDOH Form
An 18-item measure to assess health literacy.
Time frame: Assessment data will be collected at baseline and 3-month follow-up.
Started May 2026 (actual). Primary completion is estimated for Sep 2028, 28 months after the start.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 28 months is above that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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University of Hawaii