A Diabetes Prevention Study Targeting High Risk Individuals With Education and Ongoing Support

Type 2 Diabetes Mellitus Clinical Trial

— PREVENTION  

Official title:

A Randomised Controlled Trial to Investigate an Educational Programme and Continuous Monitoring to Prevent Diabetes in Individuals With Screen Detected Pre-diabetes in a Multi-ethnic Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677937
• Other study ID #: UHL10564
• Status: Completed
• Phase: N/A
• First received: May 13, 2008
• Last updated: December 4, 2014
• Start date: May 2009
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Health authority: UK: National Health Service
• Study type: Interventional

Clinical Trial Summary

The study aims to identify people at high diabetes risk within the local population and then implement and evaluate a pragmatic and low-cost diabetes prevention programme containing structured education on lifestyle, physical activity and food choices. An ongoing support framework will continue to reinforce and maintain the participant's individual goals to prevent the development of diabetes and reduce cardiovascular risk.

Therefore the principal question is: can we significantly reduce the incidence of diabetes through structured education in a high risk multi-ethnic UK population?

Description:

T2DM is an increasing chronic disease affecting over 2 million people in England alone, shortens life and consumes 10% of NHS resources. At diagnosis many have established complications involving damage to the eyes, kidneys, feet and heart. There is a need to focus efforts to prevent this devastating disease. One in 7 adults have Pre-diabetes (PDM) with 50% developing T2DM over the next 5-10 years. There is clear evidence that treating subjects with PDM with an intensive lifestyle modification programme (LSMP) dramatically reduces T2DM. These programmes are not cost effective, involve intensive use of resources and are unproven in the UK. Some minority ethnic groups have a higher risk of T2DM, any LSMP would need to be culturally sensitive. Our objective is to test if we can develop a low cost but effective LSMP for the UK. We will develop a training programme to skill healthcare professionals and non-professionals and so called 'lay' educators to deliver the LSMP. Benefits of lay educators are patient involvement in a patient centred service and the contribution to building capacity within the NHS workforce. We will develop a simple self-assessment tool to identify those at highest risk of T2DM. We will conduct a clinical trial, testing the LSMP in 50 practices and 816 patients. The practices will be randomised to either a control or intervention 'arm'. Control practices will give information to patients at risk in line with current best practice. Subjects in the Intervention practices will be invited to the LSMP and will receive 6 hours of group education over 3 months plus ongoing contact. Subjects will be followed for 3 years. The LSMP will encourage individuals to scrutinise information, ask questions, and self-manage their condition, using simple, non-technical language and visual aids. This approach has been effective in T2DM and we will use this model along with expertise in physical activity and lifestyle change, working with leading experts. The study is designed to show if we can significantly reduce the risk of developing T2DM, as well as the effect on weight, blood pressure, patients' quality of life, physical activity and dietary behaviours. We will demonstrate its cost effectiveness to ensure relevance to the NHS. The research team have international expertise in prevention of T2DM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 748
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Patients that will be included into the study if they have either / or

• Diagnosed with Pre-Diabetes (IGT or IFG)

• Aged 40 - 75 if English speaking European or 25 - 75 if South Asian

• Able to attend group education sessions

Exclusion Criteria:

Patients will be excluded from the study if they are:

• Unable to give consent

• Unable to attend group education sessions

• Diagnosis of diabetes at screening or during the study

• Require an interpreter for language other than South Asian

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Modified DESMOND education and ongoing support
6 hours of education with 1 month of inclusion, 3 years of ongoing support including annual refresher sessions

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester	Leicester	Leicestershire

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals, Leicester	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in incidence of diabetes at 3 years		3 years from entry into the study	No
Secondary	change in hba1c, fasting and post glucose levels, cardiovascular risk (framingham), presence of MetS (NCEP ATP III)		3 years from enrollment into the study	No

External Links

•   in-dept diabetes information site from University Hospitals of Leicester