Email updates

Keep up to date with the latest news and content from Cardiovascular Diabetology and BioMed Central.

Open Access Study protocol

Let’s prevent diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation

Laura J Gray1, Kamlesh Khunti1, Sian Williams2, Stephanie Goldby2, Jacqui Troughton2, Thomas Yates3, Alastair Gray4, Melanie J Davies35* and for the Let’s Prevent Collaborators

Author Affiliations

1 Department of Health Sciences, University of Leicester, Leicester, UK

2 Diabetes Research, University Hospitals of Leicester, Leicester, UK

3 Department of Cardiovascular Sciences, University of Leicester, Leicester, UK

4 Health Economics Research Centre, Department of Public Health, University of Oxford, Oxford, UK

5 Department of Cardiovascular Sciences, Leicester Diabetes Centre (Broadleaf), Leicester General Hospital, University of Leicester, Gwendolen Road, Leicester, LE5 4PW, UK

For all author emails, please log on.

Cardiovascular Diabetology 2012, 11:56  doi:10.1186/1475-2840-11-56

Published: 20 May 2012

Abstract

Background

The prevention of type 2 diabetes is a globally recognised health care priority, but there is a lack of rigorous research investigating optimal methods of translating diabetes prevention programmes, based on the promotion of a healthy lifestyle, into routine primary care. The aim of the study is to establish whether a pragmatic structured education programme targeting lifestyle and behaviour change in conjunction with motivational maintenance via the telephone can reduce the incidence of type 2 diabetes in people with impaired glucose regulation (a composite of impaired glucose tolerance and/or impaired fasting glucose) identified through a validated risk score screening programme in primary care.

Design

Cluster randomised controlled trial undertaken at the level of primary care practices. Follow-up will be conducted at 12, 24 and 36 months. The primary outcome is the incidence of type 2 diabetes. Secondary outcomes include changes in HbA1c, blood glucose levels, cardiovascular risk, the presence of the Metabolic Syndrome and the cost-effectiveness of the intervention.

Methods

The study consists of screening and intervention phases within 44 general practices coordinated from a single academic research centre. Those at high risk of impaired glucose regulation or type 2 diabetes are identified using a risk score and invited for screening using a 75 g-oral glucose tolerance test. Those with screen detected impaired glucose regulation will be invited to take part in the trial. Practices will be randomised to standard care or the intensive arm. Participants from intensive arm practices will receive a structured education programme with motivational maintenance via the telephone and annual refresher sessions. The study will run from 2009–2014.

Discussion

This study will provide new evidence surrounding the long-term effectiveness of a diabetes prevention programme conducted within routine primary care in the United Kingdom.

Trial registration

Clinicaltrials.gov NCT00677937

Keywords:
Type 2 diabetes; Prevention; Impaired glucose regulation; Cluster randomised controlled trial; Screening