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. 2019 Dec 9;9(12):e033358. doi: 10.1136/bmjopen-2019-033358.


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.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Diabetes Mellitus / prevention & control*
  • Diet, Healthy / nursing
  • Humans
  • Infant, Newborn, Diseases / prevention & control*
  • New Zealand
  • Obesity / complications
  • Obesity / diet therapy*
  • Obesity / nursing
  • Pilot Projects
  • Pragmatic Clinical Trials as Topic
  • Prediabetic State / complications
  • Prediabetic State / diet therapy*
  • Prediabetic State / nursing
  • Primary Care Nursing / methods*
  • Prospective Studies
  • Qualitative Research

Supplementary concepts

  • Diabetes Mellitus, Transient Neonatal, 1

Associated data

  • ANZCTR/ACTRN12617000591358