A community based primary prevention programme for type 2 diabetes integrating identification and lifestyle intervention for prevention: the Let's Prevent Diabetes cluster randomised controlled trial

Abstract

Aims: Prevention of type 2 diabetes (T2DM) is a priority in healthcare, but there is a lack of evidence investigating how to effectively translate prevention research into a UK primary care setting. We assessed whether a structured education programme targeting lifestyle and behaviour change was effective at preventing progression to T2DM in people with prediabetes.. Materials and methods:44 General Practices were randomised to receive either standard care or a six hour group structured education programme with an annual refresher course, and regular phone contact. Participants were followed up for 3 years. The primary outcome was progression to T2DM.Results: Eight hundred and eighty participants were included (36% female, mean age 64 years, 16% ethnic minority group); 131 participants developed T2DM. There was a nonsignificant 26% reduced risk of developing T2DM in the intervention arm compared to standard care (HR 0.74, 95%CI 0.48, 1.14, p=0.18). The reduction in T2DM risk when excluding those who did not attend the initial education session was also non-significant (HR 0.65, 0.41, 1.03, p=0.07). There were statistically significant improvements in HbA1c (-0.06, -0.11, -0.01), LDL cholesterol (-0.08, -0.15, -0.01), sedentary time (-26.29, -45.26, -7.32) and step count (498.15, 162.10, 834.20) when data were analysed across all time points. Conclusions:This study suggests that a relatively low resource, pragmatic diabetes prevention programme resulted in modest benefits to biomedical, lifestyle and psychosocial outcomes, however the reduction to the risk of T2DM did not reach significance. The findings have important implications for future research and primary care.Trial Registration: ISRCTN80605705

Clinical impact of lifestyle interventions for the prevention of diabetes: an overview of systematic reviews

“…We have not systematically searched for more recent primary studies not included in the reviews considered here. However, the latest update from the DPP is in keeping with the results reviewed,43 as are the results of additional recent trials,44 45 including trials based in routine practice, where clinical benefits were found to be modest 4647 We excluded non-English language publications that we were unable to access (see figure 1).…”

Cost-effectiveness of a pragmatic structured education intervention for the prevention of type 2 diabetes: economic evaluation of data from the Let's Prevent Diabetes cluster-randomised controlled trial

“…Eight hundred and eighty patients were enrolled in the cluster RCT from July 2009 to June 2011, with 447 patients (51%) in the intervention group and 433 (49%) in the standard care group 10. Those randomised to standard care received a booklet giving information on risk factors for T2DM and how physical activity and lifestyle change can be used to prevent or delay the disease.…”

“…The primary outcome of the Let's Prevent Diabetes randomised controlled trial (RCT) was progression to T2DM during 3 years. Overall, there was a non-significant 26% reduction in the risk of developing T2DM in the intervention arm compared with standard care (p=0.18) 10. A significant reduction in progression to T2DM was seen in the intervention arm compared with standard care when only those who attended all of the education sessions (ie, the initial 6 hours plus the two annual refresher sessions) were included in the analysis (LJ Gray, T Yates, J Troughton, et al .…”

Pre-diabetes: opportunity or overdiagnosis?

“…A recent large-scale randomised controlled trial to evaluate the effect of a type 2 diabetes prevention lifestyle intervention (Let's Prevent) in a UK community setting failed to show a statistically significant reduction in progression to type 2 diabetes at 3 years compared with normal care, 9 that is, it failed to do the thing that it was supposed to do. Retrospective re-analysis of the data did show a significant reduction in progression to diabetes in the subgroup of patients who engaged and then attended subsequent sessions, with the greatest benefit seen for the 29.1% of patients randomised to the intervention who attended all sessions.…”