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


CONCLUSIONS
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.


BACKGROUND
(ClinicalTrials.gov) registration number: NCT00284609.
Vadstrup
Eva S
ES
Department of Endocrinology and Gastroenterology, Bispebjerg University Hospital, Copenhagen, Denmark. eva.vadstrup@gmail.com
Frølich
Anne
A
Perrild
Hans
H
Borg
Eva
E
Røder
Michael
M
D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D015992:Body Mass Index; D003376:Counseling; D003718:Denmark; D003924:Diabetes Mellitus, Type 2 / Q000178:diet therapy / Q000534:rehabilitation*; D015444:Exercise; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D010353:Patient Education as Topic; D010809:Physical Fitness; D011320:Primary Health Care / Q000379:methods*; D011446:Prospective Studies; D011788:Quality of Life; D012648:Self Care / Q000379:methods
D001786:Blood Glucose