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

Official title

Peau o le Vasa: Accelerating the Currents of Health Advances for Pasifika People

Overview

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.

Detailed description

Native Hawaiians and Pacific Islanders (NHPIs) continue to disproportionally experience high rates of cardiometabolic conditions, including obesity, hypertension, type 2 diabetes, and cardiovascular disease. To address these inequities, the Diabetes Prevention Program's Lifestyle Intervention (DPP-LI) was developed and subsequently culturally and contextually adapted into the PILI Lifestyle Program (PLP). Through consolidation and collaboration with NHPIs to revamp the DPP-LI, the original 16 lessons were modified into 8 lessons delivered over a 3-month period. These lessons offer empirically supported strategies, based on the Social Cognitive Theory, to improve healthy eating, physical activity, and time and stress management.

Community Health Workers (CHWs) serve as frontline public health workers and trusted community resources who can effectively disseminate and implement cardiometabolic-related interventions across diverse settings. The trusting relationship CHWs have with communities enables them to serve as a liaison and intermediaries between health, social, and cultural services and the community, facilitating access to services and improving their quality and cultural competence. NHPI CHWs are uniquely positioned to deliver effective interventions that improve cardiometabolic health outcomes and address their social determinants.

The PLP was adapted to include a Social Determinants of Health (SDOH) component and evaluated for its effectiveness in ClinicalTrials NCT06471595, resulting in what is now known as the PILI Pasifika Program (PPP).

Interventions

• Behavioral PILI (Partnership for Improving Lifestyle Intervention) Pasifika Program
  The PILI Pasifika Program (PPP) is an adapted 3-month behavioral lifestyle intervention with an enhanced social determinants of health (SDOH) component focused on initiating weight loss and addressing social and cultural challenges, such as access to healthy foods, housing, and employment issues, among Native Hawaiians and Pacific Islanders (NHPIs). The 3-month PPP includes 8 lessons that offer empirically supported strategies (e.g., plate method, stimulus control), grounded in Social Cognitive

Primary outcome measures

• Hemoglobin A1C [Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.]
• Lipid Panel [Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.]
• Blood Pressure [Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.]
• Weight [Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.]
• Body Mass Index (BMI) [Time frame: Assessment data will be collected at baseline and 3-month follow-up.]

Secondary outcome measures (12)

• Dietary Questionnaire [Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.]
• Brief Physical Activity Questionnaire [Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.]
• Food Literacy Form [Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.]
• Well-Being Questionnaire [Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.]
• Food Insecurity Form [Time frame: Assessment data will be collected at baseline, 3-month follow-up, and 9-month follow-up.]
• Food Access Form [Time frame: Assessment data will be collected at baseline and 3-month follow-up.]
• Food Access SDOH Form [Time frame: Assessment data will be collected at baseline and 3-month follow-up.]
• Medical Care Access SDOH Form [Time frame: Assessment data will be collected at baseline and 3-month follow-up.]
• Dental Care SDOH Form [Time frame: Assessment data will be collected at baseline and 3-month follow-up.]
• Housing SDOH Form [Time frame: Assessment data will be collected at baseline and 3-month follow-up.]
• Transportation and Environment SDOH Form [Time frame: Assessment data will be collected at baseline and 3-month follow-up.]
• Social and Emotional Health SDOH Form [Time frame: Assessment data will be collected at baseline and 3-month follow-up.]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• National Association of Pasifika Organizations — Fayetteville
• Papa Ola Lokahi — Honolulu

Publications

• Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013 Dec 1;8:139. doi: 10.1186/1748-5908-8-139. PMID 24289295
• Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1. PMID 25889199
• Waltz TJ, Powell BJ, Matthieu MM, Damschroder LJ, Chinman MJ, Smith JL, Proctor EK, Kirchner JE. Use of concept mapping to characterize relationships among implementation strategies and assess their feasibility and importance: results from the Expert Recommendations for Implementing Change (ERIC) study. Implement Sci. 2015 Aug 7;10:109. doi: 10.1186/s13012-015-0295-0. PMID 26249843
• Kaholokula JK, Look M, Mabellos T, Ahn HJ, Choi SY, Sinclair KA, Wills TA, Seto TB, de Silva M. A Cultural Dance Program Improves Hypertension Control and Cardiovascular Disease Risk in Native Hawaiians: A Randomized Controlled Trial. Ann Behav Med. 2021 Oct 4;55(10):1006-1018. doi: 10.1093/abm/kaaa127. PMID 33677520
• DePue JD, Dunsiger S, Seiden AD, Blume J, Rosen RK, Goldstein MG, Nu'usolia O, Tuitele J, McGarvey ST. Nurse-community health worker team improves diabetes care in American Samoa: results of a randomized controlled trial. Diabetes Care. 2013 Jul;36(7):1947-53. doi: 10.2337/dc12-1969. Epub 2013 Feb 7. PMID 23393217
• Rouquette A, Falissard B. Sample size requirements for the internal validation of psychiatric scales. Int J Methods Psychiatr Res. 2011 Dec;20(4):235-49. doi: 10.1002/mpr.352. Epub 2011 Oct 24. PMID 22020761
• Kwan BM, McGinnes HL, Ory MG, Estabrooks PA, Waxmonsky JA, Glasgow RE. RE-AIM in the Real World: Use of the RE-AIM Framework for Program Planning and Evaluation in Clinical and Community Settings. Front Public Health. 2019 Nov 22;7:345. doi: 10.3389/fpubh.2019.00345. eCollection 2019. PMID 31824911
• Gupta N, Verma R, Dhiman RK, Rajsekhar K, Prinja S. Cost-Effectiveness Analysis and Decision Modelling: A Tutorial for Clinicians. J Clin Exp Hepatol. 2020 Mar-Apr;10(2):177-184. doi: 10.1016/j.jceh.2019.11.001. Epub 2019 Nov 26. PMID 32189934

Identifiers

NCT: NCT07387393 · Peau o le Vasa Phase II · OT2HL158287

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗