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

Abstract

IntroductionPre-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 analysisFour 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 disseminationThis 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 numberACTRN12617000591358; Pre-results.

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The effectiveness of goal setting on glycaemic control for people with type 2 diabetes and prediabetes: A systematic review and meta‐analysis

“…A description of the approach to goal setting, training and preparation of the participant, the process of goal selection, and information on how goals are intended to influence behaviour and clinical practice should be included (Levack et al, 2015). A practical example would be the development of a training manual to facilitate treatment fidelity and the replication of studies (Coppell et al, 2019).…”