Peau o le Vasa: Accelerating the Currents of Health Advances for Pasifika People
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
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:
- 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.
- 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.
- To evaluate the cost and cost-effectiveness of implementing the PPP across community settings.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program (Behavioral)
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.
干预措施: PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program (Behavioral)
结局指标
主要结局
Body Mass Index (BMI)
时间窗: 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.
Hemoglobin A1C
时间窗: 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.
Lipid Panel
时间窗: 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.
Blood Pressure
时间窗: 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).
Weight
时间窗: 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).
次要结局
- Well-Being Questionnaire(Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.)
- Food Access Form(Assessment data will be collected at baseline and 3-month follow-up.)
- Food Access SDOH Form(Assessment data will be collected at baseline and 3-month follow-up.)
- Medical Care Access SDOH Form(Assessment data will be collected at baseline and 3-month follow-up.)
- Dental Care SDOH Form(Assessment data will be collected at baseline and 3-month follow-up.)
- Housing SDOH Form(Assessment data will be collected at baseline and 3-month follow-up.)
- Transportation and Environment SDOH Form(Assessment data will be collected at baseline and 3-month follow-up.)
- Social and Emotional Health SDOH Form(Assessment data will be collected at baseline and 3-month follow-up.)
- Health Literacy SDOH Form(Assessment data will be collected at baseline and 3-month follow-up.)
- Food Insecurity Form(Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.)
- Dietary Questionnaire(Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.)
- Brief Physical Activity Questionnaire(Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.)
- Food Literacy Form(Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.)
- Social Connection and Isolation(Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.)