{"rowid": 96, "title": "[\"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\"]", "DOI": "10.1136/bmjopen-2019-033358", "URL": "http://dx.doi.org/10.1136/bmjopen-2019-033358", "created": "2019-12-10T05:19:18Z", "subject": "[\"General Medicine\"]", "references-count": "0", "is-referenced-by-count": "0", "ISSN": "[\"2044-6055\", \"2044-6055\"]", "container-title": "BMJ Open", "abstract": "<jats:sec><jats:title>Introduction</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>Four hundred participants with pre-diabetes (New Zealand definition glycated haemoglobin 41\u201349\u2009mmol/mol) and a body mass index <jats:underline>&gt;</jats:underline>25\u2009kg/m<jats:sup>2</jats:sup> will be recruited through eight primary care practices in Hawke\u2019s 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\u2019s perspective at 2 years.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p>ACTRN12617000591358; Pre-results.</jats:p></jats:sec>", "author_number": "10", "orcids": "[\"http://orcid.org/0000-0003-0996-2874\"]", "names": "[\"Kirsten Coppell\", \"Trish Freer\", \"Sally Abel\", \"Lisa Whitehead\", \"David Tipene-Leach\", \"Andrew R Gray\", \"Tony Merriman\", \"Trudy Sullivan\", \"Jeremy Krebs\", \"Leigh Perreault\"]", "award_numbers": "[\"16/344\"]", "funder_names": "[\"Health Research Council of New Zealand\"]", "funder_dois": "[\"10.13039/501100001505\"]"}