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

ISRCTN ISRCTN19583050
DOI https://doi.org/10.1186/ISRCTN19583050
ClinicalTrials.gov number NCT00677937
Secondary identifying numbers UHLPRE01
Submission date
06/06/2008
Registration date
11/07/2008
Last edited
23/03/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Melanie Davies
Scientific

Leicester Diabetes Centre (Broadleaf)
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Phone +44 116 258 6481
Email melanie.davies@uhl-tr.nhs.uk

Study information

Study designParallel controlled cluster randomised trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)GP practice
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePrevention of diabetes using structured education and continuous support programme in those with pre-diabetes in a multi-ethnic population
Study acronymPREVENTION
Study objectivesStructured education and continuous support programme reduce the incidence of diabetes in a multi-ethnic population with pre-diabetes.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPre-diabetes
InterventionIntervention 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 typeBehavioural
Primary outcome measureReduction in the incidence of diabetes at three years
Secondary outcome measures1. 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 study start date01/09/2008
Completion date31/12/2012

Eligibility

Participant type(s)All
Age groupAdult
SexBoth
Target number of participants816
Key inclusion criteria1. Aged 40 - 70 years (if White European)
2. Aged 25 - 70 years (if South Asian)
3. Able to attend group education sessions
Key exclusion criteria1. Unable to give informed consent
2. Diagnosis of diabetes
Date of first enrolment01/09/2008
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre

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

Website http://www.uhl-tr.nhs.uk/
ROR logo "ROR" https://ror.org/02fha3693

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 20/05/2012 Yes No
Results article screening results 23/12/2014 Yes No
Results article baseline results 23/07/2015 Yes No

Editorial Notes

23/03/2018: Publication references added.
26/02/2016: No publications found, verifying study status with principal investigator.