Condition category
Signs and Symptoms
Date applied
06/06/2008
Date assigned
11/07/2008
Last edited
26/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Melanie Davies

ORCID ID

Contact details

Leicester Diabetes Centre (Broadleaf)
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 116 258 6481
melanie.davies@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00677937

Protocol/serial number

UHLPRE01

Study information

Scientific title

Prevention of diabetes using structured education and continuous support programme in those with pre-diabetes in a multi-ethnic population

Acronym

PREVENTION

Study hypothesis

Structured education and continuous support programme reduce the incidence of diabetes in a multi-ethnic population with pre-diabetes.

Ethics approval

Not provided at time of registration

Study design

Parallel controlled, cluster randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pre-diabetes

Intervention

Intervention arm:
Six hours of education within one month of diagnosis, either as one full day, two half days, or 4 x 2 hours (delivered with interpreters for participants whose first language is not english); follow-up will be for three years with clinical assessments at 6, 12, 24, 23 months. Continuous support will be regular telephone contact, website and additional written material.

Control arm:
Standard care as per national guidelines currently general lifestyle advice and written material follow-up will be for three years with clinical assessments at 6, 12, 24, 23 months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Reduction in the incidence of diabetes at three years.

Secondary outcome measures

1. Reduction in cardiovascular disease (CVD) risk (assessed using the current Framingham risk equation, standard for CVD risk assessment for General Practice in the UK), measured at baseline and 6, 12, 24, 23 months
2. Reduction in HbA1c, fasting and two-hour glucose, measured at baseline and 6, 12, 24, 23 months

Overall trial start date

01/09/2008

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 40 - 70 years (if White European)
2. Aged 25 - 70 years (if South Asian)
3. Able to attend group education sessions

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

816

Participant exclusion criteria

1. Unable to give informed consent
2. Diagnosis of diabetes

Recruitment start date

01/09/2008

Recruitment end date

31/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester Diabetes Centre (Broadleaf)
Leicester
LE5 4PW
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

Trust Headquarters
Gwendolyn House
Gwendolyn Road
Leicester
LE5 4QF
United Kingdom

Sponsor type

Government

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RG-PG-0606-1272)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/02/2016: No publications found, verifying study status with principal investigator.