Study Protocol: The Norfolk Diabetes Prevention Study [NDPS]: a 46 month multi - centre, randomised, controlled parallel group trial of a lifestyle intervention [with or without additional support from lay lifestyle mentors with Type 2 diabetes] to prevent transition to Type 2 diabetes in high risk groups with non - diabetic hyperglycaemia, or impaired fasting glucose.

BACKGROUND: This 7 year NIHR programme [2011-2018] 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. The NDPS programme recognizes the need to reduce intervention costs through group delivery and the use of lay mentors with T2DM, the realities of normal primary care, and the complexity of the current glycaemic categorisation of T2DM risk. METHODS: NDPS identifies people at highest risk of T2DM on the databases of 135 general practices in the East of England for further screening with 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 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 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).

Cost-effectiveness of a lifestyle intervention in preventing Type 2 diabetes.

OBJECTIVES: Previous research has suggested people with impaired fasting glucose (IFG) are less likely to develop Type 2 diabetes (T2DM) if they receive prolonged structured diet and exercise advice. This study examined the within-trial cost-effectiveness of such lifestyle interventions. METHODS: Screen-detected participants with either newly diagnosed T2DM or IFG were randomized 2:1 to intervention versus control (usual care) between February and December 2009, in Norfolk (UK). The intervention consisted of group based education, physiotherapy and peer support sessions, plus telephone contacts from T2DM volunteers. We monitored healthcare resource use, intervention costs, and quality of life (EQ-5D). The incremental cost per quality-adjusted life-year (QALY) gain (incremental cost effectiveness ratio [ICER]), and cost effectiveness acceptability curves (CEAC) were estimated. RESULTS: In total, 177 participants were recruited (118 intervention, 59 controls), with a mean follow-up of 7 months. Excluding screening and recruitment costs, the mean cost was estimated to be £551 per participant in the intervention arm, compared with £325 in the control arm. The QALY gains were -0.001 and -0.004, respectively. The intervention was estimated to have an ICER of £67,184 per QALY (16 percent probability of being cost-effective at the £20,000/QALY threshold). Cost-effectiveness estimates were more favorable for IFG participants and those with longer follow-up (≥ 4 months) (ICERs of £20,620 and £17,075 per QALY, respectively). CONCLUSIONS: Group sessions to prevent T2DM were not estimated to be within current limits of cost-effectiveness. However, there was a large degree of uncertainty surrounding these estimates, suggesting the need for further research.

A motivational peer support program for type 2 diabetes prevention delivered by people with type 2 diabetes: the UEA-IFG feasibility study.

PURPOSE: The purpose of this study was to develop a peer support program for individuals at high risk of type 2 diabetes as part of a novel Diabetes Prevention Programme (The UEA-IFG Study). Lay members of the public with existing type 2 diabetes volunteered as peer supporters (termed type 2 trainers) for participants at high risk of developing type 2 diabetes. The feasibility of type 2 trainer recruitment, training, and retention was tested. METHODS: Between January and September 2009, 1500 potential type 2 trainers with existing type 2 diabetes were contacted and 168 (11%) expressed an interest. From this group, 26 type 2 trainers were appointed to begin training. All completed 7 training seminars, covering diabetes prevention, nutrition, physical activity, listening skills, motivation, and goal planning. Motivational calls were made every 12 weeks to each study participant by each type 2 trainer in addition to health care professional-delivered education sessions. RESULTS: Twenty-six type 2 trainers were recruited to enter the program. One type 2 trainer withdrew before beginning their role. The retention rate was high, with 22 (89%) of the type 2 trainers continuing until study end (July 2010; 20 months), with a total of 240 phone calls made. CONCLUSION: The recruiting and training of lay volunteers with existing type 2 diabetes as type 2 trainers to support study participants at risk of developing the same condition was a cost-effective strategy in comparison to employing salaried health care professionals and warrants further investigation on health outcomes.