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. Issue 12 (9th December 2019)

• Record Type: Journal Article
• Authors: Coppell, Kirsten; Freer, Trish; Abel, Sally; Whitehead, Lisa; Tipene-Leach, David; Gray, Andrew R; Merriman, Tony; Sullivan, Trudy; Krebs, Jeremy; Perreault, Leigh
• Is Part Of: BMJ open. Volume 9:Issue 12(2019)
• Publication Date: 2019-12-09
• Subjects: diet therapy -- indigenous populations -- pre-diabetes -- primary care nursing -- qualitative research -- weight loss; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2019-033358
• Languages: English
• ISSNs: 2044-6055

Abstract

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 2 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.