Type 2 Diabetes MellitusPREVENTIONNCT00677937
A Diabetes Prevention Study Targeting High Risk Individuals With Education and Ongoing Support
A study testing Modified DESMOND education and ongoing support in people with Type 2 Diabetes Mellitus, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
The study aims to identify people at high diabetes risk within the local population and then implement and evaluate a pragmatic and low-cost diabetes prevention programme containing structured education on lifestyle, physical activity and food choices. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Modified DESMOND education and ongoing support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 748 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2009to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients will be excluded from the study if they are:
- Unable to give consent
- Unable to attend group education sessions
- Diagnosis of diabetes at screening or during the study
- Require an interpreter for language other than South Asian
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Leicester
Leicester, Leicestershire, LE1 5WW
About this study
Official title: A Randomised Controlled Trial to Investigate an Educational Programme and Continuous Monitoring to Prevent Diabetes in Individuals With Screen Detected Pre-diabetes in a Multi-ethnic Population
The study aims to identify people at high diabetes risk within the local population and then implement and evaluate a pragmatic and low-cost diabetes prevention programme containing structured education on lifestyle, physical activity and food choices. An ongoing support framework will continue to reinforce and maintain the participant's individual goals to prevent the development of diabetes and reduce cardiovascular risk.
Therefore the principal question is: can we significantly reduce the incidence of diabetes through structured education in a high risk multi-ethnic UK population?
Read the detailed description
T2DM is an increasing chronic disease affecting over 2 million people in England alone, shortens life and consumes 10% of NHS resources. At diagnosis many have established complications involving damage to the eyes, kidneys, feet and heart. There is a need to focus efforts to prevent this devastating disease. One in 7 adults have Pre-diabetes (PDM) with 50% developing T2DM over the next 5-10 years. There is clear evidence that treating subjects with PDM with an intensive lifestyle modification programme (LSMP) dramatically reduces T2DM. These programmes are not cost effective, involve intensive use of resources and are unproven in the UK. Some minority ethnic groups have a higher risk of T2DM, any LSMP would need to be culturally sensitive. Our objective is to test if we can develop a low cost but effective LSMP for the UK. We will develop a training programme to skill healthcare professionals and non-professionals and so called 'lay' educators to deliver the LSMP. Benefits of lay educators are patient involvement in a patient centred service and the contribution to building capacity within the NHS workforce. We will develop a simple self-assessment tool to identify those at highest risk of T2DM. We will conduct a clinical trial, testing the LSMP in 50 practices and 816 patients. The practices will be randomised to either a control or intervention 'arm'. Control practices will give information to patients at risk in line with current best practice. Subjects in the Intervention practices will be invited to the LSMP and will receive 6 hours of group education over 3 months plus ongoing contact. Subjects will be followed for 3 years. The LSMP will encourage individuals to scrutinise information, ask questions, and self-manage their condition, using simple, non-technical language and visual aids. This approach has been effective in T2DM and we will use this model along with expertise in physical activity and lifestyle change, working with leading experts. The study is designed to show if we can significantly reduce the risk of developing T2DM, as well as the effect on weight, blood pressure, patients' quality of life, physical activity and dietary behaviours. We will demonstrate its cost effectiveness to ensure relevance to the NHS. The research team have international expertise in prevention of T2DM.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Modified DESMOND education and ongoing support
- Keywords
- diabetes mellitus, prevention, education, impaired glucose tolerance, multi-ethnic
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified DESMOND education and ongoing supportBehavioural
6 hours of education with 1 month of inclusion, 3 years of ongoing support including annual refresher sessions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention to include education and ongoing support Receives: Behavioral: Modified DESMOND education and ongoing support |
| 2 | No intervention | Control to receive standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in incidence of diabetes at 3 years
Measured: 3 years from entry into the study
Secondary outcomes (1)
change in hba1c, fasting and post glucose levels, cardiovascular risk (framingham), presence of MetS (NCEP ATP III)
Measured: 3 years from enrollment into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startMay 2009
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 748 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Melanie Davies, MD, FRCP, Principal investigator, University Hospitals, LeicesterKamlesh Khunti, Principal investigator, Univeristy of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677937
- Sponsor's protocol ID
- UHL10564
- Acronym
- PREVENTION
- Status last verified
- Dec 2014
- First submitted
- 13 May 2008
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yates T, Gray LJ, Henson J, Edwardson CL, Khunti K, Davies MJ. Impact of Depression and Anxiety on Change to Physical Activity Following a Pragmatic Diabetes Prevention Program Within Primary Care: Pooled Analysis From Two Randomized Controlled Trials. Diabetes Care. 2019 Oct;42(10):1847-1853. doi: 10.2337/dc19-0400. Epub 2019 Aug 9.
PubMed 31399440Yates T, Henson J, Edwardson C, Bodicoat DH, Davies MJ, Khunti K. Differences in levels of physical activity between White and South Asian populations within a healthcare setting: impact of measurement type in a cross-sectional study. BMJ Open. 2015 Jul 23;5(7):e006181. doi: 10.1136/bmjopen-2014-006181.
PubMed 26204908Bodicoat DH, O'Donovan G, Dalton AM, Gray LJ, Yates T, Edwardson C, Hill S, Webb DR, Khunti K, Davies MJ, Jones AP. The association between neighbourhood greenspace and type 2 diabetes in a large cross-sectional study. BMJ Open. 2014 Dec 23;4(12):e006076. doi: 10.1136/bmjopen-2014-006076.
PubMed 25537783Gray LJ, Khunti K, Williams S, Goldby S, Troughton J, Yates T, Gray A, Davies MJ; Let's Prevent Collaborators. Let's prevent diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation. Cardiovasc Diabetol. 2012 May 20;11:56. doi: 10.1186/1475-2840-11-56.
PubMed 22607160
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Investigate an Educational Programme and Continuous Monitoring to Prevent Diabetes in Individuals With Screen Detected Pre-diabetes in a Multi-ethnic Population
- ClinicalTrials.gov ID
- NCT00677937
- Acronym / sponsor ID
- PREVENTION / UHL10564
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes mellitus, prevention, education, impaired glucose tolerance, multi-ethnic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 748 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- May 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to identify people at high diabetes risk within the local population and then implement and evaluate a pragmatic and low-cost diabetes prevention programme containing structured education on lifestyle, physical activity and food choices. An ongoing support framework will continue to reinforce and maintain the participant's individual goals to prevent the development of diabetes and reduce cardiovascular risk.
Therefore the principal question is: can we significantly reduce the incidence of diabetes through structured education in a high risk multi-ethnic UK population?
Detailed description
T2DM is an increasing chronic disease affecting over 2 million people in England alone, shortens life and consumes 10% of NHS resources. At diagnosis many have established complications involving damage to the eyes, kidneys, feet and heart. There is a need to focus efforts to prevent this devastating disease. One in 7 adults have Pre-diabetes (PDM) with 50% developing T2DM over the next 5-10 years. There is clear evidence that treating subjects with PDM with an intensive lifestyle modification programme (LSMP) dramatically reduces T2DM. These programmes are not cost effective, involve intensive use of resources and are unproven in the UK. Some minority ethnic groups have a higher risk of T2DM, any LSMP would need to be culturally sensitive. Our objective is to test if we can develop a low cost but effective LSMP for the UK. We will develop a training programme to skill healthcare professionals and non-professionals and so called 'lay' educators to deliver the LSMP. Benefits of lay educators are patient involvement in a patient centred service and the contribution to building capacity within the NHS workforce. We will develop a simple self-assessment tool to identify those at highest risk of T2DM. We will conduct a clinical trial, testing the LSMP in 50 practices and 816 patients. The practices will be randomised to either a control or intervention 'arm'. Control practices will give information to patients at risk in line with current best practice. Subjects in the Intervention practices will be invited to the LSMP and will receive 6 hours of group education over 3 months plus ongoing contact. Subjects will be followed for 3 years. The LSMP will encourage individuals to scrutinise information, ask questions, and self-manage their condition, using simple, non-technical language and visual aids. This approach has been effective in T2DM and we will use this model along with expertise in physical activity and lifestyle change, working with leading experts. The study is designed to show if we can significantly reduce the risk of developing T2DM, as well as the effect on weight, blood pressure, patients' quality of life, physical activity and dietary behaviours. We will demonstrate its cost effectiveness to ensure relevance to the NHS. The research team have international expertise in prevention of T2DM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Modified DESMOND education and ongoing supportIntervention to include education and ongoing support |
| 2 | No intervention | –Control to receive standard care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Unable to give consent
- Unable to attend group education sessions
- Diagnosis of diabetes at screening or during the study
- Require an interpreter for language other than South Asian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified DESMOND education and ongoing support6 hours of education with 1 month of inclusion, 3 years of ongoing support including annual refresher sessions | Behavioural | 1 |
Primary outcome
Reduction in incidence of diabetes at 3 years
Time frame: 3 years from entry into the study
1 secondary outcome
change in hba1c, fasting and post glucose levels, cardiovascular risk (framingham), presence of MetS (NCEP ATP III)
Time frame: 3 years from enrollment into the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Derived from this study: PubMed 31399440Yates T, Gray LJ, Henson J, Edwardson CL, Khunti K, Davies MJ. Impact of Depression and Anxiety on Change to Physical Activity Following a Pragmatic Diabetes Prevention Program Within Primary Care: Pooled Analysis From Two Randomized Controlled Trials. Diabetes Care. 2019 Oct;42(10):1847-1853. doi: 10.2337/dc19-0400. Epub 2019 Aug 9.
- Derived from this study: PubMed 26204908Yates T, Henson J, Edwardson C, Bodicoat DH, Davies MJ, Khunti K. Differences in levels of physical activity between White and South Asian populations within a healthcare setting: impact of measurement type in a cross-sectional study. BMJ Open. 2015 Jul 23;5(7):e006181. doi: 10.1136/bmjopen-2014-006181.
- Derived from this study: PubMed 25537783Bodicoat DH, O'Donovan G, Dalton AM, Gray LJ, Yates T, Edwardson C, Hill S, Webb DR, Khunti K, Davies MJ, Jones AP. The association between neighbourhood greenspace and type 2 diabetes in a large cross-sectional study. BMJ Open. 2014 Dec 23;4(12):e006076. doi: 10.1136/bmjopen-2014-006076.
- Derived from this study: PubMed 22607160Gray LJ, Khunti K, Williams S, Goldby S, Troughton J, Yates T, Gray A, Davies MJ; Let's Prevent Collaborators. Let's prevent diabetes: study protocol for a cluster randomised controlled trial of an educational intervention in a multi-ethnic UK population with screen detected impaired glucose regulation. Cardiovasc Diabetol. 2012 May 20;11:56. doi: 10.1186/1475-2840-11-56.
- in-dept diabetes information site from University Hospitals of LeicesterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Davies, MD, FRCP principal investigator
University Hospitals, Leicester
Kamlesh Khunti principal investigator
Univeristy of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified DESMOND education and ongoing support in people with Type 2 Diabetes Mellitus, run by University Hospitals, Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in incidence of diabetes at 3 years (time frame: 3 years from entry into the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00677937, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.