Clinical trial NCT06471595: 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
Official title: Peau o le Vasa: Accelerating the Currents of Health Equity for Pasifika People
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Weight Loss Trial
Cardiometabolic Syndrome
Hypertension
Dyslipidemia
Pre-diabetes
Type 2 Diabetes Mellitus
Keywords: Weight loss intervention
CHWs
Community Health Workers
PILI Lifestyle Program
Curriculum
Social Determinants of Health (SDoH)
U.S. Pacific Jurisdictions
Continental U.S.
Pacific
Hawai'i
Economic stability
Physical and Neighborhood Environment
Education
Food
Community and Social Context
Health Care System
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: National Association of Pasifika Organizations
name: Papa Ola Lōkahi
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-06-24
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized controlled trial (RCT).
Primary purpose: TREATMENT

Brief 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.

Detailed description: Our target populations are Native Hawaiians and Pacific Islanders (NHPIs) 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 (HTN), type 2 diabetes (T2D), and cardiovascular disease (CVD). 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 colonization of the Pacific and SDOH disadvantages led to the proliferation of sedentary lifestyles and calorie-dense, nutrient-poor foods (e.g., processed and fast foods) that were inexpensive, accessible, and have become part of the daily diet of many NHPIs and a big contributor to their chronic disease risk. NHPIs have higher rates of obesity, HTN, T2D, and CVD as well as chronic kidney disease, a consequence of HTN and T2D when compared to non-Hispanic Whites. NHPIs get many of these conditions at younger ages than non-Hispanic Whites and Asian Americans. They are more likely to be diagnosed with multiple chronic medical conditions and at later stages or greater severity, to be readmitted to the hospital, and to be frequent users of the emergency room and outpatient services. NHPIs have the lowest life expectancy (nearly ten years lower) compared to non-Hispanic Whites and Asian Americans.

To address the cardiometabolic health inequities in NHPIs, the Diabetes Prevention Program's Lifestyle Intervention (DPP-LI) was culturally and contextually adapted for them and called the PILI Lifestyle Program (PLP). Based on NHPI community engagement, the PLP consolidated the original 16 DPP-LI lessons into 8 lessons delivered over 3 months, with two additional community-identified topics added into these lessons (i.e., economically healthy eating and talking with participants' doctor). The lessons offer empirically supported strategies (e.g., plate method, stimulus control) based on the social cognitive theory to improve healthy eating, physical activity, and time and stress management. At each lesson, participants develop an individualized plan using SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) goals. The cultural adaptions included making food, exercise, and other lifestyle examples relevant to NHPIs. PLP was designed to be group-delivered (10-12 people) by a trained, community-based peer educator across different types of settings. Each lesson can be delivered between 1 hour and 1.5 hours, depending on the size of the group. The 3-month PLP has been found effective for improving weight loss, blood pressure, and physical activity frequency and functioning and reducing the consumption of dietary fat in overweight/obese NHPIs with co-morbid cardiometabolic conditions.

SDOH, defined as the conditions in which people are born, live, learn, work, play, and age, affect a person's ability to adopt and maintain healthier behaviors. SDOH are underlying drivers of unfair and avoidable differences in the risk for cardiometabolic-related conditions. They include income, food security, social norms, segregation, and language and literacy. NHPIs face many SDOH disadvantages that serve as barriers to accessing healthier lifestyles and quality healthcare. The 2020 U.S. Census shows 22.7% of NHPIs live below the federal poverty level and 9.1% were uninsured compared to 10.3% and 6.3% of non-Hispanic Whites, respectively. NHPIs are overrepresented as Supplemental Nutrition Assistance Program (SNAP) and Women Infants and Children (WIC) beneficiaries. Food insecurity is 3 times greater among NHPIs compared to non-Hispanic Whites. In terms of education attainment, only 24% of NHPIs have a college degree compared to 37% of students overall in the U.S. The investigators have already identified the major SDOH challenges faced by NHPIs, such as economic stability, physical and neighborhood environment, education, food, community and social context, and health care system. If adapted to address SDOH barriers, lifestyle interventions, like the PLP, can improve their long-term effects on adopting and maintaining healthier behaviors.

CHWs, serving as frontline public health workers and trusted community resources, can effectively disseminate and implement cardiometabolic-related interventions across different settings. The trusting relationship CHWs have with communities enables them to serve as a liaison, link, and intermediary between health and social services and the community to facilitate access to services and improve the quality and cultural and linguistic competence of these services. When it comes to addressing the health needs of NHPI communities, NHPI CHWs are uniquely positioned to deliver effective interventions to improve cardiometabolic health outcomes and their social determinants. Studies of NHPI CHWs have shown that they can effectively deliver interventions for primary and secondary prevention of cardiometabolic conditions among at-risk NHPIs. For example, they are effective in delivering culturally tailored lifestyle interventions to improve overweight/obesity, hemoglobin A1c (HbA1c) in those with T2D, and blood pressure control in those with uncontrolled HTN. The authors of a 2015 systemic review of Asian American and NHPI CHW programs concluded that CHWs from these communities serve an important role in improving outcomes for these underserved communities because they are uniquely positioned to provide culturally and linguistically tailored disease management strategies and peer support. They also found a need to increase efforts in documenting and evaluating core competency-based training of CHW in Asian American and NHPI communities.

Thus, this project will test the efficacy of a 3-month PLP + SDOH curriculum. the investigators will enhance the PLP by adding an SDOH component. Following is a list of the lessons and potential SDOH activities. However, the specific activity may vary based on the group's participants and the CHW.

PLP Lesson: The Benefits of Lifestyle Change; Setting Goals; Ways to Stay Motivated.

PLP Lesson: Being Active; Exercising Safely; Three Ways to Eat Less Fat. PLP Lesson: Get Moving; Tracking Progress; Being a Fat Detective (Finding Hidden Fats); Move Those Muscles.

PLP Lesson: Healthy Eating with the Plate Method; 3 Right Ways to Healthy Eating Out; Heart-Strengthening Activities.

SDOH activity: Accessing healthier foods-e.g., Visit by Land Grant program to develop home gardens or vegetable boxes for apartment dwellers.

PLP Lesson: Tip the Calorie Balance; Economics of Healthy Eating (Meal Planning).

SDOH activity: Job/Career - e.g., Support in job search and training. PLP Lesson: Of What's Around You (Battling Temptation); Make Social Cues Work for You.

SDOH activity: Housing - e.g., Visit by the local housing authority (low-income housing) on rental/deposit assistance for low earners, housing co-op, etc.

PLP Lesson: Problem-Solving Skills (Exploring Options); Talking with the Doctor (General Skills for Effective Communication).

SDOH activity: Legal-e.g., Visit by local legal aid to assist with immigration/migrant issues and legal support services.

PLP Lesson: Managing Negative Thoughts and Emotions; Controlling Stress; Review of Lessons.

Fifteen experienced CHWs from our network will deliver the PLP+SDOH to eligible NHPIs. 15 cohorts of 10-12 NHPI (n=160) participants ≥18 years of age with a self-reported cardiometabolic condition (i.e., pre-diabetes/type 2 diabetes, hypertension, dyslipidemia, and/or overweight/obesity \[BMI ≥ 25\]) will be enrolled and randomized to either the PLP+SDOH arm or to the waitlist control arm. In cohorts of 10-12 participants at each of the 15 community settings, a 1:1 randomization will be done immediately following baseline assessment so that 5-6 will be randomized to PLP+SDOH and 5-6 to waitlist control per cohort. Overall, 80 participants will be randomized to PLP+SDOH and 80 to waitlist control. The investigators will conduct the pilot RCT and implement the PLP+SDOH. The participants randomized to PLP+SDOH will immediately receive the intervention by a trained CHW. Those randomized to control will receive nothing from us while the intervention arm is underway.

Eligibility criteria: Inclusion Criteria:

* NHPI participants over 18 years of age with a self-reported (e.g., Have you been told by a physician that you have diabetes?) cardiometabolic condition (i.e., pre-diabetes/T2D, HTN, dyslipidemia, and/or overweight/obesity \[BMI ≥ 25\])

Exclusion Criteria:

* Not NHPI, NHPI participants under 18 years of age, and without a self-reported (e.g., Have you been told by a physician that you have diabetes?) cardiometabolic condition (i.e., pre-diabetes/T2D, HTN, dyslipidemia, and/or overweight/obesity \[BMI ≥ 25\])

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: Assessment data will be collected at baseline and 3-month follow-up.
measure: Blood Cholesterol
timeFrame: Assessment data will be collected at baseline and 3-month follow-up.
measure: Blood pressure
timeFrame: Assessment data will be collected at baseline and 3-month follow up.
measure: Height
timeFrame: Assessment data are collected at baseline.
measure: Weight
timeFrame: Assessment data will be collected at baseline and 3-month follow-up.
Secondary outcomes:
measure: Dietary Questionnaire
timeFrame: Assessment data will be collected at baseline and 3-month follow-up.
measure: Brief Physical Activity Questionnaire
timeFrame: Assessment data will be collected at baseline and 3-month follow-up.
measure: Well-Being Questionnaire
timeFrame: Assessment data will be collected at baseline and 3-month follow-up.
measure: Access to Health Care and Social Needs Form
timeFrame: Assessment data will be collected at baseline and 3-month follow-up.
measure: Household Food Patterns Form
timeFrame: Assessment data will be collected at baseline and 3-month follow-up.
measure: Food Literacy Form
timeFrame: Assessment data will be collected at baseline and 3-month follow-up.
measure: Food Insecurity Form
timeFrame: Assessment data will be collected at baseline and 3-month follow-up.
measure: Nutrition Environment Form
timeFrame: Assessment data will be collected at baseline and 3-month follow-up.
measure: Social Cohesion Form
timeFrame: Assessment data will be collected at baseline and 3-month follow-up.
measure: Protocol for Responding to and Assessing Patient Assets, Risks, and Experiences (PRAPARE) Risk Assessment Tool
timeFrame: Assessment data will be collected at baseline and 3-month follow-up.
measure: Information and Trust Questionnaire
timeFrame: Assessment data will be collected at baseline and 3-month follow-up.
measure: Social Connection and Isolation
timeFrame: Assessment data will be collected at baseline and 3-month follow-up.
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: National Association Of Pasifika Organizations
state: Arkansas
city: Springdale
country: United States
facility: Arkansas Coalition of Marshallese
state: Arkansas
city: Honolulu
country: United States
facility: Papa Ola Lokahi
state: Hawaii
city: Honolulu
country: United States
facility: Ke Ola Mamo
state: Hawaii
Study officials:
affiliation: University of Hawaii
name: Joseph K Kaholokula, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Papa Ola Lokahi
name: Sheri Daniels, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Association of Pasifika Organizations
name: Nia Aitaoto, PhD
role: PRINCIPAL_INVESTIGATOR
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