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
NCT Number: NCT06471595
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Weight Loss Trial|Cardiometabolic Syndrome|Hypertension|Dyslipidemia|Pre-diabetes|Type 2 Diabetes Mellitus
Interventions: BEHAVIORAL: Partnership for Improving Lifestyle Intervention (PILI) Lifestyle Program + Social Determinants of Health (SDOH) Component
Sponsor: University of Hawaii
Collaborators: National Association of Pasifika Organizations|Papa Ola Lōkahi|National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 268
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-09-01
Locations: Arkansas Coalition of Marshallese, Springdale, Arkansas, 72764, United States|Hui Malama Ola Na 'Oiwi, Hilo, Hawaii, 96720, United States|Hawai'i Coalition for Immigrant Rights, Honolulu, Hawaii, 96813, United States|Papa Ola Lokahi, Honolulu, Hawaii, 96813, United States|Ke Ola Mamo, Honolulu, Hawaii, 96817, United States|Nurture Cultivate Inc, Honolulu, Hawaii, 96817, United States|Kapolei Community Development Corporation, Kapolei, Hawaii, 96707, United States|Ka'ū Rural Health Community Association, Pāhala, Hawaii, 96720, United States|Hui No Ke Ola Pono, Wailuku, Hawaii, 96793, United States

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.

Primary Outcome Measures: 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 Outcome Measures: 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., Assessment data will be collected at baseline and 3-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 and 3-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 and 3-month follow-up.|Access to Health Care and Social Needs Form, A 9-item form to evaluate access to health care places, insurance plan, length of appointment time, confidence in filling out medical forms, transportation issues, neighborhood physical activity level, housing situation and food management., Assessment data will be collected at baseline and 3-month follow-up.|Household Food Patterns Form, A 4-item questionnaire on household food patterns will be used to ask participants' household food patterns to assess the frequency of meal planning, using a shopping list, eating with other household members, and bringing prepared food home. The responses and scores range from 1- 1 day, 2- 2-3 days, 3- 4-5 days, 4- 6 days, 5- 7 days. Higher scores indicate greater household food patterns., Assessment data will be collected at baseline and 3-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 and 3-month follow-up.|Food Insecurity Form, A 19-item questionnaire on food insecurity will be used to measure household food supply. This form measures food security as high or marginal food security, low food security, and very low food security. Responses of "yes", "often true", "sometimes true", "every month", and "some months" are coded as affirmative. The higher the score, the lower the food security., Assessment data will be collected at baseline and 3-month follow-up.|Nutrition Environment Form, A 2-item scale to assess access and availability of transportation to food locations and travel time via walking., Assessment data will be collected at baseline and 3-month follow-up.|Social Cohesion Form, A 4-item form to assess social cohesion in the neighborhood environment. The items include question about willingness to help, harmony, trust, and shared values. The scoring is from 1 for strongly disagree, 3 for neutral, and 5 for strongly agree. A score is estimated by taking the average across all items within the scale. Higher score indicates greater social cohesion., Assessment data will be collected at baseline and 3-month follow-up.|Protocol for Responding to and Assessing Patient Assets, Risks, and Experiences (PRAPARE) Risk Assessment Tool, The national standardized PRAPARE assessment tool will be used to ask participants' social drivers of health., Assessment data will be collected at baseline and 3-month follow-up.|Information and Trust Questionnaire, A 10-item scale measuring perceptions of trust in resources to provide correct health information. The scoring ranges from Not at all, A little, A great deal, and Does not apply., Assessment data will be collected at baseline and 3-month follow-up.|Social Connection and Isolation, To assess how often social and emotional support is received. Responses range from Always, Usually, Sometimes, Rarely, and Never., Assessment data will be collected at baseline and 3-month follow-up.