BMC Public Health Study protocol Lifestyle intervention for type 2 diabetes patients – trial protocol of The Copenhagen Type 2 Diabetes Rehabilitation Project Eva S Vadstrup*1, Anne Frølich2, Hans Perrild1, Eva Borg3 and Michael Røder1,4 BioMed Central Open Access Address: 1Department of Endocrinology and Gastroenterology, Bispebjerg University Hospital, Copenhagen, Denmark, 2Department of Integrated Healthcare, Bispebjerg University Hospital, Copenhagen, Denmark, 3Health Care Centre Oesterbro, Copenhagen, Denmark and 4Department of Cardiology and Endocrinology, Hillerød University Hospital, Hillerød, Denmark Email: Eva S Vadstrup* - eva.vadstrup@gmail.com; Anne Frølich - anne.frolich@dadlnet.dk; Hans Perrild - hp03@bbh.regionh.dk; Eva Borg - eva.borg@psv.regionh.dk; Michael Røder - mir@dadlnet.dk * Corresponding author Published: 29 May 2009 BMC Public Health 2009, 9:166 doi:10.1186/1471-2458-9-166 This article is available from: http://www.biomedcentral.com/1471-2458/9/166 Received: 5 April 2009 Accepted: 29 May 2009 © 2009 Vadstrup et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract Background: Current guidelines recommend education, physical activity and changes in diet for type 2 diabetes patients, yet the composition and organization of non-pharmacological care are still controversial. Therefore, it is very important that programmes aiming to improve non- pharmacological treatment of type 2 diabetes are developed and evaluated. The Copenhagen Type 2 Diabetes Rehabilitation Project aims to evaluate the effectiveness of a new group-based lifestyle rehabilitation programme in a Health Care Centre in primary care. Methods/Design: The group-based diabetes rehabilitation programme consists of empowerment-based education, supervised exercise and dietary intervention. The effectiveness of this multi-disciplinary intervention is compared with conventional individual counselling in a Diabetes Outpatient Clinic and evaluated in a prospective and randomized controlled trial. During the recruitment period of 18 months 180 type 2 diabetes patients will be randomized to the intervention group and the control group. Effects on glycaemic control, quality of life, self-rated diabetes symptoms, body composition, blood pressure, lipids, insulin resistance, beta-cell function and physical fitness will be examined after 6, 12 and 24 months. Discussion: The Copenhagen Type 2 Diabetes Rehabilitation Project evaluates a multi-disciplinary non-pharmacological intervention programme in a primary care setting and provides important information about how to organize non-pharmacological care for type 2 diabetes patients. Trail Registration: ClinicalTrials.gov registration number: NCT00284609. Background Type 2 diabetes mellitus (T2DM) is a chronic disease with severe late complications and high mortality. The increas- ing prevalence of T2DM is mainly due to reduced physical activity and consumption of unhealthy food and larger portion sizes in genetic susceptible individuals. Lifestyle intervention can prevent development of T2DM in sub- jects with impaired glucose tolerance [1,2]. To improve Page 1 of 8 (page number not for citation purposes)