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BMJ 2008;336:491-495 (1 March), doi:10.1136/bmj.39474.922025.BE (published 14 February 2008)
M J Davies, professor of diabetes medicine1, S Heller, professor of clinical diabetes2, T C Skinner, associate professor in health psychology3, M J Campbell, professor of medical statistics4, M E Carey, national director5, S Cradock, nurse consultant6, H M Dallosso, research associate5, H Daly, nurse consultant7, Y Doherty, consultant clinical psychologist8, S Eaton, consultant diabetologist8, C Fox, consultant physician9, L Oliver, consultant dietitian8, K Rantell, research fellow in statistics4, G Rayman, consultant physician10, K Khunti, professor of primary care diabetes and vascular medicine 11, on behalf of the Diabetes Education and Self Management for Ongoing and Newly Diagnosed Collaborative
1 Department of Cardiovascular Sciences, University of Leicester, Leicester LE1 5WW, 2 Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield Medical School, 3 School of Psychology, University of Wollongong, Australia, 4 School of Health and Related Research, University of Sheffield, 5 DESMOND Programme, Diabetes Research Team, University Hospitals of Leicester NHS Trust, Leicester, 6 Portsmouth Hospitals NHS Trust and Portsmouth City Teaching PCT, Queen Alexandra Hospital, Portsmouth, 7 Diabetes Research Team, University Hospitals of Leicester NHS Trust, Leicester, 8 Diabetes Resource Centre, Northumbria Healthcare NHS Foundation Trust, Tyne and Wear, 9 Northampton General Hospital, Northampton, 10 Ipswich Diabetes Service, Ipswich General Hospital NHS Trust, Suffolk, 11 Department of Health Sciences, University of Leicester
Correspondence to: M J Davies melanie.davies{at}uhl-tr.nhs.uk
Design Multicentre cluster randomised controlled trial in primary care with randomisation at practice level.
Setting 207 general practices in 13 primary care sites in the United Kingdom.
Participants 824 adults (55% men, mean age 59.5 years).
Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care.
Main outcome measures Haemoglobin A1c levels, blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, and emotional impact of diabetes at baseline and up to 12 months.
Main results Haemoglobin A1c levels at 12 months had decreased by 1.49% in the intervention group compared with 1.21% in the control group. After adjusting for baseline and cluster, the difference was not significant: 0.05% (95% confidence interval –0.10% to 0.20%). The intervention group showed a greater weight loss: –2.98 kg (95% confidence interval –3.54 to –2.41) compared with 1.86 kg (–2.44 to –1.28), P=0.027 at 12 months. The odds of not smoking were 3.56 (95% confidence interval 1.11 to 11.45), P=0.033 higher in the intervention group at 12 months. The intervention group showed significantly greater changes in illness belief scores (P=0.001); directions of change were positive indicating greater understanding of diabetes. The intervention group had a lower depression score at 12 months: mean difference was –0.50 (95% confidence interval –0.96 to –0.04); P=0.032. A positive association was found between change in perceived personal responsibility and weight loss at 12 months (β=0.12; P=0.008).
Conclusion A structured group education programme for patients with newly diagnosed type 2 diabetes resulted in greater improvements in weight loss and smoking cessation and positive improvements in beliefs about illness but no difference in haemoglobin A1c levels up to 12 months after diagnosis.
Trial registration Current Controlled Trials ISRCTN17844016 [controlled-trials.com] .
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