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.
Keywords:
diet therapy; indigenous populations; pre-diabetes; primary care nursing; qualitative research; weight loss.
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Publication types
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Clinical Trial Protocol
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Research Support, Non-U.S. Gov't
MeSH terms
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Diabetes Mellitus / prevention & control*
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Diet, Healthy / nursing
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Humans
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Infant, Newborn, Diseases / prevention & control*
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New Zealand
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Obesity / complications
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Obesity / diet therapy*
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Obesity / nursing
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Pilot Projects
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Pragmatic Clinical Trials as Topic
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Prediabetic State / complications
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Prediabetic State / diet therapy*
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Prediabetic State / nursing
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Primary Care Nursing / methods*
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Prospective Studies
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Qualitative Research
Supplementary concepts
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Diabetes Mellitus, Transient Neonatal, 1
Associated data
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ANZCTR/ACTRN12617000591358