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 (NCT)	NCT00677937
Protocol serial number	UHLPRE01
Sponsor	University Hospitals of Leicester NHS Trust (UK)
Funder	National Institute of Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RG-PG-0606-1272)

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

Primary study design	Interventional
Study design	Parallel controlled cluster randomised trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Prevention of diabetes using structured education and continuous support programme in those with pre-diabetes in a multi-ethnic population
Study acronym	PREVENTION
Study objectives	Structured 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) studied	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	Behavioural
Primary outcome measure(s)	Reduction in the incidence of diabetes at three years
Key secondary outcome measure(s)	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
Completion date	31/12/2012

Eligibility

Participant type(s)	All
Age group	Adult
Sex	All
Target sample size at registration	816
Key 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
Key exclusion criteria	1. Unable to give informed consent 2. Diagnosis of diabetes
Date of first enrolment	01/09/2008
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Leicester Diabetes Centre (Broadleaf)

Leicester
LE5 4PW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	screening results	23/12/2014		Yes	No
Results article	baseline results	23/07/2015		Yes	No
Protocol article	protocol	20/05/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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