BMC Public Health 2009, 9:166 http://www.biomedcentral.com/1471-2458/9/166 The teams from the health care centre and from the diabe- tes outpatient clinic meet on a regular basis to share knowledge and to ensure a common understanding of care and agreement on the components of the pro- grammes in the two organizations. Control group On the basis of the same empowerment approach the life- style intervention at the Diabetes Out-patient clinic at Bis- pebjerg Hospital includes four monthly 1-hour sessions of individual counselling with a diabetes nurse specialist [19,20] (Figure 4). The nurse is educated in the use of the motivational interviewing technique and has a bachelor degree in education. Using storytelling patients are given information about diabetes in general, medication, risk factors and late complications of T2DM. They receive guidance in self-monitoring of blood-glucoses and on how to increase their level of physical activity. The programme also includes three individual counsel- ling sessions with a dietician, who is also educated in the use of the motivational interviewing technique[24]. The patients' set personal goals and the dietician develops in cooperation with the patient, a diet-schedule based on biochemical, anthropometrical and medical records including patients' motivation and attitudes. The sched- ule and goals are evaluated at two 30-minute follow-up visits. The patients receive 45 minutes guidance and instructions about foot-care from a podiatrist. Finally patients are offered an optional smoking cessation course if required. Pharmacological treatment Both intervention programmes are non-pharmacological. The endocrinologist or the general practitioner treating and monitoring the patients prior to the study continue as the patients' physician (disease manager) during and after the intervention. Recent guidelines on pharmacological treatment are followed [25]. The study does not include changes in principles for the pharmacological treatment. Patients are asked to report any alternation in their medi- cation and these will be quantified by the study investiga- tor and used in the analyses as a covariate. Outcome measures and data collection The primary outcome measure is glycosylated haemo- globin (HbA1c). Secondary outcome measures are self- rated quality of life and diabetes symptoms. Explanatory outcome measures include blood pressure, lipid profile, body weight, waist circumference, insulin resistance and beta-cell function estimates, and physical fitness. All out- come measures are collected at baseline and at follow-up visits after 6, 12 and 24 months. At every visit, biochemical, anthropometrical, physiologi- cal and physical values are obtained. The same investiga- tor measures the anthropometrical and the physiological outcomes throughout the study. Physiotherapists at the health care centre and at the outpatient clinic complete the physical tests. The patients fill in two self-adminis- tered questionnaires on quality of life and diabetes related symptoms at each visit. Anthropometrical measurements Weight (kg) is measured without shoes in indoor clothing and the same equipment will be used throughout the study. Height (cm) without shoes is only measured at baseline. Waist circumference (cm) is measured at a level midway between the lower rib margin and iliac crest with the sub- jects standing without clothes on and with relaxed breath- ing. Physiological measurements Electrocardiogram (ECG) is recorded at baseline. Blood pressure is measured on both arms are done using an aneroid manometer with the patient in a sitting position after 10–15 minutes of relaxed conversation. The mean of 3 consecutive measurements is used for each arm. Patients' target blood pressures are at the recommended goal of 130/80 mmHg defined according to the European guidelines [26]. Biothesiometry of the pulp on the first toe on both feet's is used for quantitative assessment of peripheral neuropa- thy. The patients will be tested by increasing the ampli- tude from zero and then the patients will indicate when they feel the vibration. The cut-off point for ulcer risk is > 25 volts [27]. Biochemical measurements Blood and urine samples are taken in the morning after an overnight fast. Plasma glucose, lipids, C Reactive Protein, creatinine and urine albumin/creatinine ratio are ana- lysed at the Department of Clinical Biochemistry, Bispeb- jerg University Hospital. Haemoglobin A1c is measured on venous whole blood samples in K2-EDTA tubes at the Department of Clinical Biochemistry, Steno Diabetes Centre [28]. Blood samples for serum C-peptide, insulin and proinsulin are centrifuged for 10 min at 3000 rpm, at 20°C immediately after sampling, and serum is isolated and frozen before analysis at the Steno Diabetes Centre. Blood samples for later analyses will be centrifuged within 60 minutes of sampling and stored frozen at -20°C. The target for haemoglobin A1c is below 6.5% according to international guidelines [27]. Page 5 of 8 (page number not for citation purposes)