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Behavioral Intervention
Lifestyle Program for Type 2 Diabetes
N/A
Waitlist Available
Led By Sheri Daniels, PhD
Research Sponsored by University of Hawaii
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
NHPI participants under 18 years of age and without a self-reported cardiometabolic condition including pre-diabetes/T2D, HTN, dyslipidemia, and/or overweight/obesity (BMI ≥ 25)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessment data will be collected at baseline and 3-month follow-up.
Awards & highlights
Summary
This trial aims to test a program called the PILI Lifestyle Program (PLP) with integrated social determinants of health components, delivered by Community Health Workers (CHWs) from Native Hawaiian and Pacific
Who is the study for?
This trial is for adult Native Hawaiians and Pacific Islanders with conditions like pre-diabetes, type 2 diabetes, high blood pressure, dyslipidemia, or overweight/obesity. It's designed to help improve their health by addressing both lifestyle factors and social determinants of health.
What is being tested?
The PILI Lifestyle Program combined with a Social Determinants of Health component is being tested. Delivered by Community Health Workers, this study aims to see if the program can lower hemoglobin A1c levels, blood pressure, cholesterol levels, and weight in participants.
What are the potential side effects?
Since this intervention involves lifestyle changes rather than medication or medical procedures, side effects are not typical as seen in drug trials but may include discomfort from new diet or exercise routines.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18, of NHPI descent, and do not have any heart or metabolic conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessment data will be collected at baseline and 3-month follow-up.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessment data will be collected at baseline and 3-month follow-up.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood Cholesterol
Blood pressure
Height
+2 moreSecondary study objectives
Access to Health Care and Social Needs Form
Brief Physical Activity Questionnaire
Dietary Questionnaire
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Group - PLP + SDoHExperimental Treatment1 Intervention
Participants randomized to the Intervention Group will be engaged in a 3-month randomized controlled trial and receive the PLP+SDoH curriculum from a trained Community Health Worker (CHW). Each week during the 3 months, participants will meet for approximately 1-1.5 hours and be taught a PLP Lesson or engage in an SDoH activity. Participants will also be asked to undergo an assessment collection point at baseline recruitment and 3-month completion time.
Group II: Waitlist Control GroupActive Control1 Intervention
Participants randomized to the Waitlist Control Group will receive nothing from the research group while the Intervention Group is underway. Participants will be asked to undergo an assessment collection point at baseline recruitment and 3-month completion time. After the Control Group's 3-month follow-up assessment, they will be offered the PLP+SDoH curriculum.
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Who is running the clinical trial?
University of HawaiiLead Sponsor
119 Previous Clinical Trials
56,694 Total Patients Enrolled
National Association of Pasifika OrganizationsUNKNOWN
Papa Ola LōkahiUNKNOWN
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