BMC Public Health 2009, 9:166 http://www.biomedcentral.com/1471-2458/9/166 metabolism and reduce the risk of late complications of T2DM, permanent changes in lifestyle and lifelong multi- pharmacological treatment are needed [3]. cantly more in the short and long term than patients receiving conventional individual advice on changes in lifestyle. Group-based lifestyle intervention programmes for T2DM patients, including patient education or supervised exer- cise, have been evaluated in several randomized control- led trials. Education programmes alone improves glycaemic control in some studies [4,5], but not in all [6]. Group-based diabetes education seems to have a better effect on glycaemic control than individual education [7- 10]. However the studies and interventions included in these meta-analyses are very heterogeneous. Isolated aerobic exercise [11], resistance training [12], and the combination of these[13] resulted in better glycaemic outcomes compared with the control groups. Exercise in groups (exercise period ranging from 8 weeks to 12 month) lowered HbA1c approximately 0.6 percentage points [14,15]. Dietary advice is an accepted cornerstone of treatment for T2DM, but no quality data on the efficacy of diet interven- tion per se on glycaemic control, reduction in body weight, development of diabetic complications or quality of life exists for the treatment of T2DM [16]. It is still an open question whether group-based or indi- vidual lifestyle intervention programmes gives the best glycaemic control, whether exercise interventions have a long term effect and finally whether lifestyle changes can improve long term results of T2DM treatment. A new health care centre is established at Oesterbro in eastern Copenhagen as a result of a local collaboration project between the City of Copenhagen, Bispebjerg Uni- versity Hospital and general practitioners [17]. The health care centre is planned to be responsible for lifestyle reha- bilitation of patients with one or more of four selected chronic conditions – type 2 diabetes, chronic obstructive pulmonary disease, chronic heart failure and older patients with balance problems. A new rehabilitation pro- gramme combines empowerment-based education, exer- cise training and dietary advice on a group-based level as one multi-disciplinary intervention. The aim of the current study is to compare the metabolic, physiological and psychological effects of this new group- based multi-disciplinary lifestyle rehabilitation pro- gramme for T2DM patients in a primary care setting with an individual counselling programme in a diabetes outpa- tient clinic. We hypothesize that patients participating in the group-based rehabilitation programme including supervised exercise will improve their glycaemic control, self-rated diabetes symptoms and quality of life signifi- Methods/design Patient recruitment and randomization We plan to recruit patients through advertisements in local newspapers, pharmacies and from the outpatient clinic at Bispebjerg University Hospital, and by letters and e-mails to general practitioners inviting them to refer patients to the study (Figure 1). Key inclusion and exclu- sion criteria are shown in Figure 2. Diagnosis of T2DM is defined according to the criteria of WHO [18]. Patients willing to participate will be screened after written informed consent is obtained, and those fulfilling the inclusion criteria will be randomised within three weeks, stratified by gender and age (18–54 years and ≥ 55 years). A person not participating in the study creates a randomi- zation list, and the randomization is done at the baseline visit using consecutively numbered sealed envelopes. Patients will be randomised to a group-based rehabilita- tion programme (intervention group) at the Health Care Centre Oesterbro or to an individual counselling pro- gramme (control group) in the Diabetes Outpatient Clinic, Bispebjerg University Hospital. Intervention group Lifestyle rehabilitation at Health Care Centre Oesterbro consists of a multi-disciplinary intervention including three programmes (Figure 3). The education programme consists of one weekly group session of 90 minutes for 6 weeks, limited to 8 patients per group. A nurse, a physiotherapist, a dietician and a podiatrist run the sessions. The education programme is originally developed at the diabetes outpatient clinic, Bis- pebjerg University Hospital, and focuses on achievement of self-selected goals, psychosocial adaptation, enhanced control and problem solving strategies [19]. The pro- gramme is modified and adjusted to a multi-disciplinary education team, and the contents of the sessions include information on the pathophysiology of diabetes; the role inheritance and environment; education in self blood- glucose monitoring; the importance of physical activity, healthy diet, weight loss, medication, and smoking cessa- tion; the late complications of T2DM; hypertension and cardiovascular disease. The podiatrist advises patients about foot care and examines the patients' feet. The empowerment approach to diabetes education involves patient collaboration and seeks to increase the patients' knowledge and self-awareness, which enables them to take charge of their own diabetes self-management [20].The diet instruction programme consists of two 3- hours group-based cooking courses and 1 session in a Page 2 of 8 (page number not for citation purposes)