Effectiveness of the Pasifika Women's Diabetes Wellness Program (PWDWP): Protocol for a Pilot Intervention and Feasibility Randomized Controlled Trial.

Background: Type 2 diabetes poses public health challenges for Māori and Pasifika communities in Australia. The women of these communities face a greater burden from type 2 diabetes-related mortality and comorbidities. Lifestyle modification behaviors through previous women's wellness programs have been shown to reduce the risk of developing complications in established type 2 diabetes. The Pasifika Women's Diabetes Wellness Program (PWDWP) pilot study, co-designed with Māori and Pasifika communities, was aimed at addressing late hospital presentations from diabetes-related complications.

Objective: This study (1) examines the efficacy of women with type 2 diabetes in the intervention group for improved glycated hemoglobin (HbA) clinical levels and diabetes self-management compared with the control group from baseline (T) to week 12 (T) and week 24 (T; postintervention) and (2) assesses the cultural adaptability, acceptability, and feasibility of the pilot intervention for future studies.

Methods: This study uses a quasiexperimental design that involves a 24-week intervention. We recruited 50 Māori and Pasifika women with type 2 diabetes (25 in the intervention group from the south side of Brisbane and 25 in the control group from the north side of Brisbane) using participatory talanoa methodologies. The intervention group participated in face-to-face and virtual whānau education workshops (5 weeks) and had access to individual coaching and virtual support delivered by trained Māori and Pasifika health professionals and community health workers. The control group received usual care with their identified health provider. Both groups received copies of the PWDWP journal, fact sheets, and a health check passbook with tailored motivational text messages. An advisory committee was set up to oversee the program implementation, including protocols of engagement, health checks, and data collection in community settings. The quantitative data were collected at T T, and T with HbA as the primary outcome measure. Secondary outcomes measured changes in diabetes self-care and body composition (eg, BMI, waist circumference). Qualitative data will ascertain the program's feasibility and cultural adaptability using talanoa focus groups.

Results: This pilot study was approved by the Queensland University of Technology Human Ethic Research Committee (5609) and began in January 2023 after participant recruitment between July 2022 and December 2022. The final data collection including the health check, focus group, and survey data was completed in November 2023, and data analysis and reporting are expected to conclude in 2024.

Conclusions:  This study provides a blueprint for PWDWP. Collaborative partnerships with community organizations and stakeholders are crucial for program success and suggest a potential model for targeting diabetes management for Māori and Pasifika communities, emphasizing the need for culturally relevant interventions. The findings will have significant implications for policymakers and practitioners when developing and implementing public health initiatives, particularly for communities with unique cultural nuances.

Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12622001100785p; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384470&isReview=true.

International Registered Report Identifier (irrid): DERR1-10.2196/55435.