Effectiveness of a Pasifika Women's Diabetes Wellness Program (PWDWP): Protocol for a Pilot Intervention and Feasibility RCT Study.

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 behaviours through previous women's wellness programs have been shown to reduce 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 where intervention group having improved HbA1c clinical levels and diabetes self-management compared to control group from baseline (T0), week 12 (T1) to week 24 (T2) (post intervention) and (2) assesses the cultural adaptability, acceptability and feasibility of the pilot intervention for future studies.

METHODS: This study is a quasi-experimental design which involves a 24-week intervention. Fifty Māori and Pasifika women with type 2 diabetes (25 Intervention from the Southside of Brisbane and 25 Control from Northside of Brisbane) were recruited utilizing participatory talanoa methodologies. The intervention group participated in face-to-face and virtual whānau education workshops (5 weeks), 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, factsheets and health check passbook with tailored motivational text messages. An Advisory Committee (AC) 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 T0, T1, T2 with Haemoglobin A1c as primary outcome measure. Secondary outcomes measured changes in diabetes self-care and body composition (e.g body mass index (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 - December 2022. The final data collection including health check, focus group and survey data was completed in November 2023 and with data analysis and reporting 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 policy makers, practitioners when developing and implementing public health initiatives, particularly for communities with unique cultural nuances.

CLINICALTRIAL: Australian New Zealand Clinical Trials Registry (ANZCTR) Number: 12622001100785p.