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Enrolling By Invitation NCT07387393

To Test the Effectiveness and Implementation Approach of a 3-month PILI Pasifika Program Lifestyle Program With Components of Social Determinants of Health Activities in Real-world Settings (Clinical and Non-clinical Settings) Across 3 Years

Conditions: Cardiometabolic Conditions, Hypertension (HTN), Dyslipidemia, Pre-diabetes, Type 2 Diabetes Mellitus (T2DM), Overweight (BMI > 25), Weight Loss Trial

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 400
Sponsor: University of Hawaii

Location: National Association of Pasifika Organizations Fayetteville Arkansas

Summary

In this study, the investigators are conducting a Type 3 hybrid effectiveness-implementation trial to evaluate the implementation of the Community Health Workers (CHW)-delivered PILI Pasifika Program (PPP) across 3 regions, the U.S. Affiliated Pacific Islands (USAPI), the continental U.S., and Hawai'i, among 400 Native Hawaiian and Pacific Islander (NHPI) participants in two settings, (clinical and non-clinical) over a 3-year period. The PPP is a 3-month lifestyle intervention that includes a Social Determinants of Health (SDOH) component and was NHPI-adapted from the Diabetes Prevention Program's Lifestyle Program, renamed to the PILI Lifestyle Program (PLP), which demonstrated effectiveness in improving weight, blood pressure, physical activity, and diet among NHPIs. The PPP consists of 8 lifestyle lessons and 4 SDOH activities delivered over a 3-month period. The aims of this study are threefold: 1. To evaluate the implementation of the PPP across multiple community sites using a Type 3 hybrid effectiveness-implementation design guided by established frameworks such as RE-AIM and PRISM. 2. To examine participant-level outcomes associated with PPP implementation, including changes in cardiometabolic risk factors, health behaviors, and SDOH factors from baseline to 3 and 9-month follow-up. 3. To evaluate the cost and cost-effectiveness of implementing the PPP across community settings.

Eligibility Criteria

Inclusion Criteria: * Self-identify as Native Hawaiian or Pacific Islander * 18 years of age or older * Have at least one of the following self-reported cardiometabolic conditions (Overweight or obesity defined as BMI ≥ 25, pre-diabetes or diabetes, high blood pressure, and/or high cholesterol) * Able to do a moderate level of physical activity or exercise Exclusion Criteria: * Do not identify as Native Hawaiian or Pacific Islander * Under 18 years of age * Currently a student * Do not have any of the following conditions (overweight/obesity, pre-diabetes/diabetes, high blood pressure, or high cholesterol) * Have special dietary needs/dietary restrictions (due to cultural reasons and/or told by a healthcare provider) * Pregnant women * Have physical activity limitations/restrictions (told by a healthcare provider)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07387393). StuddyBuddy aggregates publicly available trial information.