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A major new study looking at the prevention of Type 2 diabetes - Let’s Prevent

A Randomised Controlled Study for the Prevention of Diabetes using an Educational Intervention and Continuous Support Programme in those with Pre-Diabetes in a Multi Ethnic Population.

Let's Prevent is funded by a National Institute for Health Research (NIHR).  Programme Grant and is the first randomised controlled study looking at whether an educational lifestyle programme (of diet and exercise) can prevent those with a condition called pre-diabetes going on to develop diabetes. 

Diabetes and impaired glucose tolerance (IGT) are increasingly appearing in younger people and, before the onset of diabetes, most people will have some degree of abnormal glucose tolerance, as has been found in previous screening studies such as STAR & ADDITION. The most efficient way to address the problem of diabetes and its complications is to prevent diabetes from developing. 

Research on patients with impaired glucose tolerance has shown that prevention is possible, particularly using lifestyle modification interventions.

Aims of the study

The aim of the study is to establish whether the use of a structured lifestyle modification programme (based on theDESMOND curriculum) prevents those with pre-diabetes going on to develop diabetes.

Recruitment to Let' Prevent is only via GP practices and it is not possible for participants to volunteer directly for this study. 

The main aims of the study are to provide:

• A multi-disciplinary approach to reducing the progression to diabetes in high risk people
• An appropriate structured education programme to target lifestyle modification and behaviour change and a culturally sensitive structured education for the Black Minority and Ethnic (BME) community
• A support and motivational maintenance programme for the duration of the study

And to:  

• Evaluate the programme to provide a low cost solution for practical health improvement

Recruitment

We are recruiting approximately 45 GP practices to the study. A screening programme will be run on practice database to identify those 40-75 of European origin or aged 25-75 of South Asian origin or who have previous Impaired Fasting Glucose (IFG) or IGT.

A risk score is then applied (with weightings for gender, ethnicity, family history of diabetes and hypertension). The top 10% of those identified will receive a letter from their GP inviting them to attend a screening session to see if they have pre-diabetes.  

Screening Clinics

Screening clinics are held at the hospitals in Leicester and also at locations near to the GP practices for convenience. At the screening clinic, after obtaining Informed consent, the participants complete a range of tests and questionnaires including:

• Oral Glucose Tolerance Test (OGTT);
• blood tests (including lipids, U&E’s, HbA1c)
• BP
• height
• weight
• waist measurements
• questionnaires related to health status and food intake
• medical history
• smoking status
• family history of diabetes etc.

They are also asked to undertake a 7-day step count following the visit using a sealed pedometer. Only those participants diagnosed with pre-diabetes will enter into the study and all results are sent to both the GP and participant.

Each GP practice is randomised (like the toss of a coin) to either the educational intervention (structured lifestyle modification programme) or control arm of the study and the participants from the practice will receive treatment accordingly.  

Those participants in the practices randomised to the educational intervention will be invited to attend an educational session (one 6-hour or two 3-hour sessions for English language or 4 sessions for interpreted languages). The educational sessions are held in small groups and, if necessary, an interpreter and translated information is available (South Asian languages only). They focus on increasing activity, weight management, dietary advice and participants are also given a handbook supporting the information given during the educational session and a pedometer to encourage walking, along with the standard written pre-diabetes information. Participants in the educational intervention arm of the study also receive phone calls every 3 months from the nursing team to support and motivate action planning and lifestyle changes, and are also invited to yearly educational refresher sessions.

Participants in the practices randomised to the control arm will receive standard patient care and information, including support and advice as per routine patient care within primary care/GP practices for those with impaired fasting glucose and/or impaired glucose tolerance.

Participation in the study lasts 3 years, during which time all participants receive regular health checks and this information will be passed on to your GP for their records.  

Interested?

If you are a GP or Practice Manager who is interested in this study and require further information, please contact the project lead.

Documents

BME Newly Diagnosed and Foundation Programme

Information Leaflet

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