Background This 7?year NIHR programme [2011C2018] tests the primary hypothesis that the NDPS diet and physical activity intervention will reduce the risk of transition to type 2 diabetes (T2DM) in groups at high risk of Type 2 diabetes. ab fasting plasma glucose and glycosylated haemoglobin [HbA1c]. Those with an elevated fasting plasma glucose [impaired fasting glucose or IFG] with or without an elevated HbA1c [non -diabetic hyperglycaemia; NDH] are randomised into three treatment arms: a control arm receiving no trial intervention, an arm receiving an intensive bespoke group-based diet and physical activity intervention, and an arm receiving the same intervention with enhanced support from people with T2DM trained as diabetes prevention mentors [DPM]. The primary end point is cumulative transition rates to T2DM between the two intervention groups, and between each intervention group and the control group at 46?months. Participants with screen detected T2DM are randomized into an equivalent prospective controlled trial with the same intervention and control arms with glycaemic control [HbA1c] at CHC 46?months as the primary end point. Participants with NDH and a normal fasting plasma glucose are randomised into an equivalent prospective controlled intervention trial with follow up for 40?months. The intervention comprises six education sessions for the first 12?weeks and then up to 15 maintenance sessions until intervention end, all delivered in groups, with additional support from a DPM in one treatment arm. Discussion The NDPS programme reports in 2018 and will provide trial outcome data for a group delivered diabetes prevention intervention, supported by lay mentors with CHC T2DM, with intervention in multiple at risk glycaemic categories, and that takes into account the realities of normal clinical practice. Trial registration ISRCTN34805606 (Retrospectively registered 16.3.16) Electronic supplementary material The online version of this article (doi:10.1186/s12889-016-3929-5) contains supplementary material, which is available to authorized users. with non -diabetic hyperglycaemia [NDH; HbA1c?42 to?<48?mmol/mol] and an elevated fasting plasma glucose [5.6 to?<6.1?mmol/l] randomised to our lifestyle intervention [standard intervention group], compared to a group randomised to this intervention enhanced by additional lay diabetes prevention mentor [DPM] input, or to a control group who do not receive any trial intervention. Project 3 hypothesis We can identify, recruit, train and retain 70 volunteers with known T2DM to become diabetes prevention mentors [DPM] to support one intervention arm in each of Projects 2 and 4. Project 4 hypothesis Mean HbA1c [as a measure of glycaemic control] will be significantly lower after 46?months intervention in participant groups with newly diagnosed screen detected T2DM [fasting plasma glucose?>7.0?mmol/l and/or HbA1c?>48?mmol/mol] randomised to the same intervention groups as CHC in Project 2 than in an equivalent control group who do not receive this trial intervention. Project 5 objective Health Rabbit Polyclonal to SPTA2 (Cleaved-Asp1185) economic analysis of all aspects of the programme. Project 6 objective To observe changes in mean HbA1c after 40?months in participants with non – diabetic hyperglycaemia [NDH; HbA1c?42 to?<48?mmol/mol] and a normal fasting plasma glucose [<5.6?mmol/l] randomised to an observational controlled trial of our standard intervention compared to a control group not receiving this intervention. Allocation into trial by glycaemic category is summarized in Table?1 Table 1 Glycaemic category [based on concordant paired baseline results] in project 1 and associated randomisation into trial Methods and design?: Description of intervention trials design Project 2 is a unblinded three - arm randomised parallel group 46?month clinical trial with randomisation of the target population at risk of T2DM (Table?1) to a control group who do not receive the research intervention, an intervention group who receive the 46?month diet and lifestyle intervention described below, an intervention group who recieve the 46?month lifestyle intervention enhanced with additional direct contact from DPM. Project 3 is a recruitment project for DPMs to service one intervention arm of Project 2. The DPM aid in the delivery of the intervention, but are themselves studied with additional observational baseline and prospective clinical and biochemical assessments at prespecified time points during their involvement. Project 4 is a three - arm randomised parallel group 46?month prospective clinical trial with randomisation of the target population with screen detected T2DM (Table?1) to a control group who do not receive the research intervention, an CHC intervention group who receive the 46?month diet and lifestyle intervention described below, an intervention group who recieve the 46?month lifestyle intervention enhanced with additional direct contact from trained volunteers with T2DM [DPM]. Project 6 is two arm randomised parallel group 40?month prospective pilot clinical trial with randomisation of the target population (Table?1) to a control group who do not receive the research intervention, an intervention group who receive the standard diet and lifestyle intervention described below. Randomisation and.