Lifestyle intervention for type 2 diabetes patients: trial protocol of The Copenhagen Type 2 Diabetes Rehabilitation Project

Eva S Vadstrup, Anne Frølich, Hans Perrild, Eva Borg, Michael Røder, Eva S Vadstrup, Anne Frølich, Hans Perrild, Eva Borg, Michael Røder

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.

Trial registration: (ClinicalTrials.gov) registration number: NCT00284609.

Figures

Figure 1
Figure 1
Flow-chart of events in the study. From recruiting patients through randomization and follow-up.
Figure 2
Figure 2
Key inclusion and exclusion criteria.
Figure 3
Figure 3
The group-based rehabilitation programme outline.
Figure 4
Figure 4
Individual outpatient counselling programme outline.

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