PILI Pasifika Program for Cardiometabolic Conditions
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a lifestyle program designed to help Native Hawaiian and Pacific Islander individuals manage weight, blood pressure, and other health conditions like diabetes and high cholesterol. The program, called the PILI Pasifika Program, includes weekly lessons and activities for three months, delivered by Community Health Workers. Researchers are testing it in two ways—Enhanced Facilitation and Standard Facilitation—to determine which is more effective and sustainable. Suitable participants have one or more conditions such as being overweight, having diabetes, high blood pressure, or high cholesterol, and can engage in moderate physical activity. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance community health programs.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What prior data suggests that the PILI Pasifika Program is safe for participants?
Research has shown that the PILI Pasifika Program (PPP) provides a safe way for Native Hawaiian and Pacific Islander participants to improve their lifestyle. This program encourages better eating and increased exercise, tailored to fit their culture with the assistance of community health workers.
Earlier studies tested the PPP, adapting it from a diabetes prevention program. Participants completed the program without serious health issues, indicating its safety and ease of use. Both the Enhanced and Standard versions effectively improved health habits, demonstrating their safety and benefits.
By focusing on lifestyle changes rather than medication, the program reduces the risk of negative side effects. Participants can expect a supportive and culturally relevant experience, with trained guides assisting them throughout the program.12345Why are researchers excited about this trial?
Researchers are excited about the PILI Pasifika Program because it offers a culturally tailored approach to managing cardiometabolic conditions, unlike standard options like medication and diet changes alone. The program involves community health workers who provide personalized support and activities that address social determinants of health, which can lead to more effective and sustainable lifestyle changes. The Enhanced Facilitation arm offers even more tailored guidance and problem-solving, aiming to improve the program's fit across diverse settings, potentially leading to better health outcomes for participants.
What evidence suggests that this trial's treatments could be effective for cardiometabolic conditions?
Research has shown that the PILI Pasifika Program (PPP) successfully helps Native Hawaiian and Pacific Islander (NHPI) communities improve their health. Studies have found that it aids in weight loss and enhances blood pressure, physical activity, and diet. The program stands out because Community Health Workers lead it, offering advice that respects cultural traditions. In this trial, participants will join either the Standard Facilitation or the Enhanced Facilitation group. In the Enhanced Facilitation, these workers receive extra support to assist participants more effectively. Overall, PPP has led to positive lifestyle and health changes, particularly in weight loss and physical abilities.12567
Who Is on the Research Team?
Joseph K Kaholokula, PhD
Principal Investigator
University of Hawaii, Department of Native Hawaiian Health
Sheri-Ann Daniels, EdD
Principal Investigator
Papa Ola Lokahi
Nia Aitaoto, PhD
Principal Investigator
National Association of Pasifika Organizations
Are You a Good Fit for This Trial?
This trial is for Native Hawaiian or Pacific Islander adults with conditions like obesity, pre-diabetes, diabetes, high blood pressure, or high cholesterol. Participants must be able to engage in moderate physical activity.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage in a 3-month PILI Pasifika Program with weekly lessons and SDoH activities
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PILI Pasifika Program - Enhanced Facilitation
- PILI Pasifika Program - Standard Facilitation
Trial Overview
The study tests the PILI Pasifika Program's effectiveness in improving lifestyle choices related to diet and exercise among participants at risk for cardiometabolic diseases. It compares standard versus enhanced facilitation methods over three years.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants in the Enhanced Facilitation group will engage in a 3-month PILI Pasifika Program (PPP) with a trained Community Health Worker (CHW). Each week during the 3-month period, participants will meet for approximately 1-1.5 hours to receive a Weekly Lesson or engage in an SDoH activity. CHWs managing participants in the Enhanced Facilitation group may receive additional support to strengthen program fit, problem-solving, and uptake across diverse settings, offering participants more tailored guidance. Participants will also complete an assessment at baseline, at 3-month program completion, and at the 9-month follow-up.
Participants in the Standard Facilitation 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Hawaii
Lead Sponsor
Papa Ola Lōkahi
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
National Association of Pasifika Organizations
Collaborator
Citations
Study Details | NCT07387393 | To Test the Effectiveness ...
In this study, the investigators are testing the effectiveness and implementation of the Community Health Workers (CHW)-delivered PILI Pasifika Program ...
PILI Pasifika Program for Cardiometabolic Conditions
The study tests the PILI Pasifika Program's effectiveness in improving lifestyle choices related to diet and exercise among participants at risk ...
The Impact of a Community Health Worker-Led Lifestyle ...
This study assessed the feasibility and effectiveness of the PILI Pasifika Program (PPP), a culturally grounded, community health worker ...
University of Hawai`i Office of Research Services PILI ` ...
Ultimately, the results were positive and showed that outcomes based on the measures of BMI reduction, weight reduction, improved physical functioning, blood ...
Effects of lifestyle interventions on weight amongst Pasifika ...
Qualitative and quantitative analysis show tailored lifestyle interventions has had an estimated small but beneficial effect on WL amongst Pasifika communities.
The PILI@Work Program: a translation of the diabetes ... - PMC
A previously translated Diabetes Prevention Program Lifestyle Intervention (DPP-LI) was adapted for delivery as a worksite-based intervention, called PILI@Work.
A Family and Community Focused Lifestyle Program...
A 6-month weight loss maintenance intervention designed for Pacific Islanders, called the PILI Lifestyle Program (PLP), was compared with a 6-month standard ...
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