AI Article Synopsis
- This study focuses on understanding the outcomes of a 6-month dietary intervention for participants with pre-diabetes and excess weight, assessing who reverts to normal glucose levels, who remains pre-diabetic, and who develops type 2 diabetes (T2DM) after two years.
- Four hundred participants from New Zealand will undergo a structured dietary program led by primary care nurses and will have their clinical data, lifestyle factors, and health-related quality of life measured over two years.
- The study has received ethical approval and aims to share findings through participant presentations, peer-reviewed publications, and conferences to help inform future health strategies.
Article 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/m 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.
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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6924756 | PMC |
| http://dx.doi.org/10.1136/bmjopen-2019-033358 | DOI Listing |
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