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
Cluster randomised trial
Trial setting
GP practices
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
Behavioural
Phase
Drug names
Primary outcome measure
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 (if study stopped)
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
All
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
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
Basic results (scientific)
Publication list
2012 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/22607160
2014 screening results in: https://www.ncbi.nlm.nih.gov/pubmed/25537783
2015 baseline results in: https://www.ncbi.nlm.nih.gov/pubmed/26204908