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Behavioral Intervention

Lifestyle Program for Type 2 Diabetes

N/A

Waitlist Available

Led By Joseph K Kaholokula, 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

No Placebo-Only Group

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessment data will be collected at baseline and 3-month follow-up. for reporting.

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 more

Secondary study objectives

Access to Health Care and Social Needs Form

Brief Physical Activity Questionnaire

Dietary Questionnaire

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 1Eligibility criteria met