Document Type
Journal Article
Publication Title
BMJ Open
Publisher
BMJ Publishing Group
School
School of Nursing and Midwifery
RAS ID
31008
Funders
Health Research Council of New Zealand.
Abstract
Introduction Pre-diabetes is a high-risk state for the development of type 2 diabetes mellitus (T2DM) and cardiovascular disease. Regression to normoglycaemia, even if transient, significantly reduces the risk of developing T2DM. The primary aim of this mixed-methods study is to determine if there are clinically relevant differences among those with pre-diabetes and excess weight who regress to normoglycaemia, those who have persistent pre-diabetes and those who progress to T2DM following participation in a 6-month primary care nurse-delivered pre-diabetes dietary intervention. Incidence of T2DM at 2 years will be examined.
Methods and analysis Four hundred participants with pre-diabetes (New Zealand definition glycated haemoglobin 41–49 mmol/mol) and a body mass index >25 kg/m2 will be recruited through eight primary care practices in Hawke’s Bay, New Zealand. Trained primary care nurses will deliver a 6-month structured dietary intervention, followed by quarterly reviews for 18 months post-intervention. Clinical data, data on lifestyle factors and health-related quality of life (HR-QoL) and blood samples will be collected at baseline, 6 months, 12 months and 24 months. Sixty participants purposefully selected will complete a semi-structured interview following the 6-month intervention. Poisson regression with robust standard errors and clustered by practice will be used to identify predictors of regression or progression at 6 months, and risk factors for developing T2DM at 2 years. Qualitative data will be analysed thematically. Changes in HR-QoL will be described and potential cost savings will be estimated from a funder’s perspective at 2 years.
Ethics and dissemination This study was approved by the Northern A Health and Disability Ethics Committee, New Zealand (Ethics Reference: 17/NTA/24). Study results will be presented to participants, published in peer-reviewed journals and presented at relevant conferences.
Trial registration number ACTRN12617000591358; Pre-results.
DOI
10.1136/bmjopen-2019-033358
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License
Comments
Coppell, K., Freer, T., Abel, S., Whitehead, L., Tipene-Leach, D., Gray, A. R., ... Perreault, L. (2019). What predicts regression from pre-diabetes to normal glucose regulation following a primary care nurse-delivered dietary intervention? A study protocol for a prospective cohort study. BMJ Open, 9(12). Available here