- 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
- 1Department of Cardiovascular Sciences, University of Leicester, Leicester LE1 5WW
- 2Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield Medical School
- 3School of Psychology, University of Wollongong, Australia
- 4School of Health and Related Research, University of Sheffield
- 5DESMOND Programme, Diabetes Research Team, University Hospitals of Leicester NHS Trust, Leicester
- 6Portsmouth Hospitals NHS Trust and Portsmouth City Teaching PCT, Queen Alexandra Hospital, Portsmouth
- 7Diabetes Research Team, University Hospitals of Leicester NHS Trust, Leicester
- 8Diabetes Resource Centre, Northumbria Healthcare NHS Foundation Trust, Tyne and Wear
- 9Northampton General Hospital, Northampton
- 10Ipswich Diabetes Service, Ipswich General Hospital NHS Trust, Suffolk
- 11Department of Health Sciences, University of Leicester
- Correspondence to: M J Davies
- Accepted 18 December 2007
Objective To evaluate the effectiveness of a structured group education programme on biomedical, psychosocial, and lifestyle measures in people with newly diagnosed type 2 diabetes.
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.
Contributors: MJD, SH, MJC, MEC, HMD, HD, SE, CF, KR, GR, TCS, and KK wrote the paper on behalf of the Diabetes Education and Self Management for Ongoing and Newly Diagnosed Collaborative. The Collaborative Steering Group comprised MJD, S Roberts, S Amiel, F Arundel, MEC, D Cavan, SC, HMD, HD, YD, SE, A Farooqi, CF, G Hawthorne, SH, P James, K Jones, E Kennedy, N Kennedy, KK, S Lucas, M MacKinnon, C Mittler, LO, GR, L Richardson, J Roddick, A Rogers, J Roland, A Setterfield, TCS, S Tesfaye, S Trowbridge, P Weir, S White, and G Wilson. The Training Strategy Group comprised SC, HD, YD, LO, and TCS. The participating primary care trusts (local coordinators) were Bath and North East Somerset (Anne Thomas; Yvonne Smith, Jody Smally); Greater Glasgow (Florence Brown, Fiona MacIntyre); Greater Peterborough primary care trust partnership (Sam Hartley); East Staffordshire (Fiona Kirkland, Kathy Rea); East Leicester and Melton Rutland and Harborough (MEC); Ipswich, Suffolk Central and Suffolk Coastal (Donna Watling, Heidi Heighton, Caroline Calver); Northampton (Penny Meade); Newcastle (Jacqui Stephenson, Michelle Hurst); North Tyneside (LO, Norma Cardill); South Leicestershire (Maxine Mays); North Sheffield and Sheffield West (Jenny Cowling, Cathy Bounekhla, Alison Iliffe); West Cumbria (Anne Eldred); and West Lothian (Reita Early, Laura Hunter). The educators were Jane Davies and Catherine Taylor (Bath and North-East Somerset); Sayjal Amin, Lorraine Martin Stacey, and Maggie Boddington (Eastern Leicester and Melton Rutland and Harborough); Anne Scott and Kath Sutton (Ipswich); Marie Caraher and Sarah White (Newcastle); Penny Meade, Kath Hall and Karen Osbourne (Northampton); LO, Susan Robinson, Anne Rodgers, and Lesley Tiffin (North Tyneside); Monica Harris and Gail Nixon (Peterborough); Pauline Cowling, Lynette Hall, and Penny Walker (Sheffield); Maxine Mays, Geri Gray and Suzanne Fenn (Leicester South); Fiona Kirkland and Karen Gale (East Staffordshire); Cheryl Taylor and Karen Rogers (West Cumbria); Debbie Halliday, May Lavelle, Katrina Phillips, and Maureen Cullen (Greater Glasgow); and Reita Early and Grace Bathgate (West Lothian). MEC was the project manager; HMD was the research associate; M Bonar, A Harding, and C Sutcliffe were the central office team; and MJC and KR were the statisticians (University of Sheffield).
Funding: This study was funded by Diabetes UK. The project office administration was funded by an unrestricted educational grant from Novo Nordisk. The researchers were independent of any of the study funders. The study sponsor was the University Hospitals of Leicester NHS Trust. The research team and the principle investigator were employees of the sponsor during the period of the study.
Competing interests: None declared.
Ethical approval: This study was approved by the Huntingdon local research ethics committee.
Provenance and peer review: Not commissioned; externally peer reviewed.
- Accepted 18 December 2007