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| ID | Type | Description | Link |
|---|---|---|---|
| OT2HL158287 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Association of Pasifika Organizations | UNKNOWN |
| Papa Ola Lōkahi | UNKNOWN |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PILI Pasifika Program - Clinical Setting | Experimental | 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. |
|
| PILI Pasifika Program - Community (Non-Clinical) Setting | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C | A finger stick sample will be collected to measure hemoglobin A1C using the A1CNow+ kit. | 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. | 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). | 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). | 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. | Assessment data will be collected at baseline and 3-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph K Kaholokula, PhD | University of Hawaii, Department of Native Hawaiian Health | Principal Investigator |
| Nia Aitaoto, PhD | National Association of Pasifika Organizations | Principal Investigator |
| Sheri-Ann Daniels, EdD | Papa Ola Lokahi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Association of Pasifika Organizations | Fayetteville | Arkansas | 72704 | United States | ||
| Papa Ola Lokahi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24289295 | Background | Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013 Dec 1;8:139. doi: 10.1186/1748-5908-8-139. | |
| 25889199 | Background | Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1. |
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A multisite, non-randomized, pragmatic implementation trial.
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Assessment data will be collected at baseline and 3-month follow-up. |
| Housing SDOH Form | A 4-item measure to assess housing situation. | 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. | 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. | Assessment data will be collected at baseline and 3-month follow-up. |
| Health Literacy SDOH Form | An 18-item measure to assess health literacy. | Assessment data will be collected at baseline and 3-month follow-up. |
| Honolulu |
| Hawaii |
| 96813 |
| United States |
| 26249843 | Background | Waltz TJ, Powell BJ, Matthieu MM, Damschroder LJ, Chinman MJ, Smith JL, Proctor EK, Kirchner JE. Use of concept mapping to characterize relationships among implementation strategies and assess their feasibility and importance: results from the Expert Recommendations for Implementing Change (ERIC) study. Implement Sci. 2015 Aug 7;10:109. doi: 10.1186/s13012-015-0295-0. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| D018149 | Glucose Intolerance |
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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