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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT00677937
First received: May 13, 2008
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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?


Condition Intervention
Type 2 Diabetes Mellitus
Behavioral: Modified DESMOND education and ongoing support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • Reduction in incidence of diabetes at 3 years [ Time Frame: 3 years from entry into the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in hba1c, fasting and post glucose levels, cardiovascular risk (framingham), presence of MetS (NCEP ATP III) [ Time Frame: 3 years from enrollment into the study ] [ Designated as safety issue: No ]

Enrollment: 748
Study Start Date: May 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intervention to include education and ongoing support
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
No Intervention: 2
Control to receive standard care

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677937

Locations
United Kingdom
University Hospitals of Leicester
Leicester, Leicestershire, United Kingdom, LE1 5WW
Sponsors and Collaborators
University Hospitals, Leicester
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Melanie Davies, MD, FRCP University Hospitals, Leicester
Principal Investigator: Kamlesh Khunti Univeristy of Leicester
  More Information

Additional Information:
No publications provided by University Hospitals, Leicester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT00677937     History of Changes
Other Study ID Numbers: UHL10564
Study First Received: May 13, 2008
Last Updated: September 4, 2012
Health Authority: UK: National Health Service

Keywords provided by University Hospitals, Leicester:
diabetes mellitus
prevention
education
impaired glucose tolerance
multi-ethnic

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014