Ignite Creation Date:
2024-07-17 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-17
Brief Title:
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
Sponsor:
University of Hawaii
Organization:
University of Hawaii
Study Overview
Official Title:
Peau o le Vasa Accelerating the Currents of Health Equity for Pasifika People
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Native Hawaiians and Pacific Islanders NHPIs are defined as the descendants of the original peoples of Polynesia eg Hawaii Sāmoa and Tonga Melanesia eg Fiji and Micronesia eg Guam Chuuk and Marshall Islands Their history with the US 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 ie 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 PLPSDOH in improving the primary outcomes of hemoglobin A1c HbA1c systolic blood pressure cholesterol and weight in 180 adult NHPIs with pre-diabetestype 2 diabetes hypertension dyslipidemia andor overweightobesity
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 PLPSDOH in improving the primary outcomes of hemoglobin A1c HbA1c systolic blood pressure cholesterol and weight in 180 adult NHPIs with pre-diabetestype 2 diabetes hypertension dyslipidemia andor overweightobesity
Detailed Description:
Our target populations are Native Hawaiians and Pacific Islanders NHPIs defined as the descendants of the original peoples of Polynesia eg Hawaii Sāmoa and Tonga Melanesia eg Fiji and Micronesia eg Guam Chuuk and Marshall Islands Their history with the US 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 ie 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 eg 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 Programs 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 ie economically healthy eating and talking with participants doctor The lessons offer empirically supported strategies eg 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 15 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 overweightobese NHPIs with co-morbid cardiometabolic conditions
SDOH defined as the conditions in which people are born live learn work play and age affect a persons 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 US Census shows 227 of NHPIs live below the federal poverty level and 91 were uninsured compared to 103 and 63 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 US 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 overweightobesity 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 groups 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-eg 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 JobCareer - eg Support in job search and training PLP Lesson Of Whats Around You Battling Temptation Make Social Cues Work for You
SDOH activity Housing - eg Visit by the local housing authority low-income housing on rentaldeposit 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-eg Visit by local legal aid to assist with immigrationmigrant 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 PLPSDOH to eligible NHPIs 15 cohorts of 10-12 NHPI n160 participants 18 years of age with a self-reported cardiometabolic condition ie pre-diabetestype 2 diabetes hypertension dyslipidemia andor overweightobesity BMI 25 will be enrolled and randomized to either the PLPSDOH arm or to the waitlist control arm In cohorts of 10-12 participants at each of the 15 community settings a 11 randomization will be done immediately following baseline assessment so that 5-6 will be randomized to PLPSDOH and 5-6 to waitlist control per cohort Overall 80 participants will be randomized to PLPSDOH and 80 to waitlist control The investigators will conduct the pilot RCT and implement the PLPSDOH The participants randomized to PLPSDOH will immediately receive the intervention by a trained CHW Those randomized to control will receive nothing from us while the intervention arm is underway
To address the cardiometabolic health inequities in NHPIs the Diabetes Prevention Programs 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 ie economically healthy eating and talking with participants doctor The lessons offer empirically supported strategies eg 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 15 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 overweightobese NHPIs with co-morbid cardiometabolic conditions
SDOH defined as the conditions in which people are born live learn work play and age affect a persons 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 US Census shows 227 of NHPIs live below the federal poverty level and 91 were uninsured compared to 103 and 63 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 US 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 overweightobesity 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 groups 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-eg 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 JobCareer - eg Support in job search and training PLP Lesson Of Whats Around You Battling Temptation Make Social Cues Work for You
SDOH activity Housing - eg Visit by the local housing authority low-income housing on rentaldeposit 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-eg Visit by local legal aid to assist with immigrationmigrant 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 PLPSDOH to eligible NHPIs 15 cohorts of 10-12 NHPI n160 participants 18 years of age with a self-reported cardiometabolic condition ie pre-diabetestype 2 diabetes hypertension dyslipidemia andor overweightobesity BMI 25 will be enrolled and randomized to either the PLPSDOH arm or to the waitlist control arm In cohorts of 10-12 participants at each of the 15 community settings a 11 randomization will be done immediately following baseline assessment so that 5-6 will be randomized to PLPSDOH and 5-6 to waitlist control per cohort Overall 80 participants will be randomized to PLPSDOH and 80 to waitlist control The investigators will conduct the pilot RCT and implement the PLPSDOH The participants randomized to PLPSDOH will immediately receive the intervention by a trained CHW Those randomized to control will receive nothing from us while the intervention arm is underway
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OT2HL158287 | NIH | None | None |