Introduction Type 2 diabetes mellitus (T2DM) and its complications are more common among Māori and Pacific people compared with other ethnic groups in New Zealand. Comprehensive and sustained approaches that address social determinants of health are required to address this condition, including culturally specific interventions. Currently, New Zealand has no comprehensive T2DM management programme for Māori or Pacific people.
Methods and analysis The Mana Tū programme was developed by a Māori-led collaborative of primary healthcare workers and researchers, and codesigned with whānau (patients and their families) in order to address this gap. The programme is based in primary care and has three major components: a Network hub, Kai Manaaki (skilled case managers who work with whānau with poorly controlled diabetes) and a cross-sector network of services to whom whānau can be referred to address the wider determinants of health. The Network hub supports the delivery of the intervention through training of Kai Manaaki, referrals management, cross-sector network development and quality improvement of the programme. A two-arm cluster randomised controlled trial will be conducted to evaluate the effectiveness of the Mana Tū programme among Māori, Pacific people or those living in areas of high socioeconomic deprivation who also have poorly controlled diabetes (glycated haemoglobin, HbA1c, >65 mmol/mol (8%)), compared with being on a wait list for the programme. A total of 400 participants will be included from 10 general practices (5 practices per group, 40 participants per practice). The primary outcome is HbA1c at 12 months. Secondary outcomes include blood pressure, lipid levels, body mass index and smoking status at 12 months. This protocol outlines the proposed study design and analysis methods.
Ethics and dissemination Ethical approval for the trial has been obtained from the New Zealand Health and Disability Ethics Committee (17/NTB/249). Findings will be presented to practices and their patients at appropriate fora, and disseminated widely through peer-reviewed publications and conference presentations.
Trial registration number ACTRN12617001276347; Pre-result.
- general diabetes
- primary care
- clinical trials
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Contributors VS wrote the first draft of the manuscript. All authors reviewed and provided feedback on the draft. YJ estimated sample size. VS, MH and YJ designed the trial. MH is the principal investigator of the study. MH, TS, JR, TT and PC developed the intervention.
Funding This work was supported by the Health Research Council of New Zealand (grant number 16-736).
Disclaimer The Health Research Council of New Zealand (also the sponsor of the trial) had no role or ultimate authority in study design and will have no role or ultimate authority in any of the following: collection, management, analysis and interpretation of data; writing of the report and the decision to submit the report for publication.
Competing interests TS and TT are employees of, and MH is a contractor to, the National Hauora Coalition, a Māori-led Primary Health Organisation. The National Hauora Coalition is the recipient of a grant for the development, implementation and evaluation of the Mana Tū programme (from the Health Research Council of New Zealand, grant number 16-736). The Mana Tū programme is being implemented in the National Hauora Coalition and its associated general practices. The National Hauora Coalition will be the Network hub for the intervention and will employ the Kai Manaaki. All other authors have nothing to disclose.
Patient consent Not required.
Ethics approval Ethical approval for the trial has been obtained from the New Zealand Health and Disability Ethics Committee (17/NTB/249).
Provenance and peer review Not commissioned; externally peer reviewed.
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