BMC Public Health 2007, 7:74 http://www.biomedcentral.com/1471-2458/7/74 nicity, smoking status, systolic blood pressure, HbA1c, total cholesterol, HDL-cholesterol) [38]. Secondary outcomes measures Secondary outcomes measures are included in a self- reported questionnaire that is filled in by the patients at home. Patients will be sent a questionnaire at baseline, after 6 and 12 months. All the secondary outcomes are included in the questionnaire, with the exception of the Patients' evaluation of the Quality of Diabetes Care Ques- tionnaire (PEQD), which is not assessed at baseline. 1. Diet is assessed by the use of the Dutch Eating Behav- iour Questionnaire (DEBQ). This is a 33-item question- naire regarding diet behaviour, scored on a five point scale (1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = very often). This questionnaire assess whether a patient is a restraint, emotional or external eater [39]. 2. Short Questionnaire to Assess Health Enhancing Phys- ical Activity (SQUASH) is used to assess physical activity. This questionnaire consists of subscales concerning (A) commuting activities, (B) leisure time activities, (C) household activities, and (D) activities at work and school [40]. 3. Smoking: Smoking is assessed by asking patients if they are a never smoker, current smoker or past smoker. 4. ASE-questionnaire: a 20-item questionnaire, created by the investigators themselves according to the ASE-model: Attitude, Social influences and self-Efficacy model [41]. To our knowledge, no validated questionnaires were available. The theoretical model and questionnaires of other running studies at their own research institute were used to develop the ASE-questionnaire. Each item is pro- vided with a 7-point Likert-type scale describing only the two end points. 5. Quality of life is measured by the EuroQol. This ques- tionnaire consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depres- sion), each with 3 levels, and a visual analogue scale on which patients rate their own health between 0 and 100 [42,43]. 6. Depression during the last week is assessed by the use of the CES-D: Center for Epidemiological Studies Depres- sion scale. This is a 20-item questionnaire with a four- point scale (1 = seldom or never, 2 = sometimes, 3 = often, 4 = mostly or always) [44]. 7. The Patient Health Questionnaire (PHQ9) is used to assess the general health of the patient. This brief PHQ consists of 9 items, measured on a four-point scale (1 = not at all, 2 = several days, 3 = more than half of the days, 4 = almost every day) in order to assess depressive disor- ders during the last two weeks [45]. 8. The patient satisfaction on the diabetes care provided by medical assistants, diabetes nurses and dieticians is measured by the use of the Patients' evaluation of the Quality of Diabetes Care Questionnaire (PEQD). For each health care provider, 14 items are evaluated on a five- point scale, ranging from "poor" to "excellent" [46]. Physical measurements Physical measurements are performed to calculate the car- diovascular risk score and to describe the patients' charac- teristics. 1. Anthropometric measurements. Body weight and height are measured for the calculation of the Body Mass Index (weight divided by height squared). Waist circum- ference is measured at the level midway between the low- est rib margin and the iliac crest. 2. Systolic and diastolic blood pressure is measured after 5 minutes of rest in seated position by Collin Press Mate (BP-8800, Komaki-City). 3. Blood samples are taken in order to determine: • fasting plasma glucose: measured in plasma by means of a hexokinase-method (Roche Diagnostics GmbH, Man- nheim, Germany). HbA 1c: measured by High Performance Liquid Chroma- tography Total cholesterol, HDL-cholesterol and triglycerides by means of enzymatic techniques (Boehringer-Mannheim, Mannheim, Germany). 4. In addition, data are collected from the patients on: hospital admission days per 6 months number of visits to general practitioner per 6 months medication changes per 6 months Sample size The sample size is calculated on the base of the minimally clinically relevant difference in changes of one of the pri- mary outcome measurements, the Oxford Risk Engine [38]. In the DCS the standard deviation of the absolute risk for cardiovascular disease, calculated with the Oxford Risk Engine, was 10%. A difference (d) between the inter- vention and control group in changes of 5% absolute risk Page 7 of 10 (page number not for citation purposes)