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
Scientific
Leicester Diabetes Centre (Broadleaf)
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
| Phone | +44 116 258 6481 |
|---|---|
| melanie.davies@uhl-tr.nhs.uk |
Study information
| Study design | Parallel controlled cluster randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/09/2008 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Leicester Diabetes Centre (Broadleaf)
Leicester
LE5 4PW
United Kingdom
LE5 4PW
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Trust Headquarters
Gwendolyn House
Gwendolyn Road
Leicester
LE5 4QF
England
United Kingdom
| Website | http://www.uhl-tr.nhs.uk/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
