NCT00677937

Brief 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
748

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

5.2 years

First QC Date

May 13, 2008

Last Update Submit

December 4, 2014

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes mellituspreventioneducationimpaired glucose tolerancemulti-ethnic

Outcome Measures

Primary Outcomes (1)

  • Reduction in incidence of diabetes at 3 years

    3 years from entry into the study

Secondary Outcomes (1)

  • change in hba1c, fasting and post glucose levels, cardiovascular risk (framingham), presence of MetS (NCEP ATP III)

    3 years from enrollment into the study

Study Arms (2)

1

EXPERIMENTAL

Intervention to include education and ongoing support

Behavioral: Modified DESMOND education and ongoing support

2

NO INTERVENTION

Control to receive standard care

Interventions

Modified DESMOND education and ongoing supportBEHAVIORAL

6 hours of education with 1 month of inclusion, 3 years of ongoing support including annual refresher sessions

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Leicester

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Related Publications (4)

  • Yates T, Gray LJ, Henson J, Edwardson CL, Khunti K, Davies MJ. Impact of Depression and Anxiety on Change to Physical Activity Following a Pragmatic Diabetes Prevention Program Within Primary Care: Pooled Analysis From Two Randomized Controlled Trials. Diabetes Care. 2019 Oct;42(10):1847-1853. doi: 10.2337/dc19-0400. Epub 2019 Aug 9.

    PMID: 31399440DERIVED

  • Yates T, Henson J, Edwardson C, Bodicoat DH, Davies MJ, Khunti K. Differences in levels of physical activity between White and South Asian populations within a healthcare setting: impact of measurement type in a cross-sectional study. BMJ Open. 2015 Jul 23;5(7):e006181. doi: 10.1136/bmjopen-2014-006181.

    PMID: 26204908DERIVED

  • Bodicoat DH, O'Donovan G, Dalton AM, Gray LJ, Yates T, Edwardson C, Hill S, Webb DR, Khunti K, Davies MJ, Jones AP. The association between neighbourhood greenspace and type 2 diabetes in a large cross-sectional study. BMJ Open. 2014 Dec 23;4(12):e006076. doi: 10.1136/bmjopen-2014-006076.

    PMID: 25537783DERIVED

  • Gray LJ, Khunti K, Williams S, Goldby S, Troughton J, Yates T, Gray A, Davies MJ; Let's Prevent Collaborators. 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. Cardiovasc Diabetol. 2012 May 20;11:56. doi: 10.1186/1475-2840-11-56.

    PMID: 22607160DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusGlucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Officials

  • Melanie Davies, MD, FRCP

    University Hospitals, Leicester

    PRINCIPAL INVESTIGATOR

  • Kamlesh Khunti

    Univeristy of Leicester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2008

First Posted

May 15, 2008

Study Start

May 1, 2009

Primary Completion

July 1, 2014

Study Completion

August 1, 2014

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

GB(1)