Lifestyle intervention for type 2 diabetes patients: trial protocol of The Copenhagen Type 2 Diabetes Rehabilitation Project. 2009

Eva S Vadstrup, and Anne Frølich, and Hans Perrild, and Eva Borg, and Michael Røder
Department of Endocrinology and Gastroenterology, Bispebjerg University Hospital, Copenhagen, Denmark. eva.vadstrup@gmail.com

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.

UI MeSH Term Description Entries
D008019 Life Style Typical way of life or manner of living characteristic of an individual or group. (From APA, Thesaurus of Psychological Index Terms, 8th ed) Lifestyle Factors,Life Style Induced Illness,Lifestyle,Factor, Lifestyle,Life Styles,Lifestyle Factor,Lifestyles
D008297 Male Males
D010353 Patient Education as Topic The teaching or training of patients concerning their own health needs. Education of Patients,Education, Patient,Patient Education
D010809 Physical Fitness The ability to carry out daily tasks and perform physical activities in a highly functional state, often as a result of physical conditioning. Fitness, Physical
D011320 Primary Health Care Care which provides integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. (JAMA 1995;273(3):192) Primary Care,Primary Healthcare,Care, Primary,Care, Primary Health,Health Care, Primary,Healthcare, Primary
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D011788 Quality of Life A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease. HRQOL,Health-Related Quality Of Life,Life Quality,Health Related Quality Of Life
D001786 Blood Glucose Glucose in blood. Blood Sugar,Glucose, Blood,Sugar, Blood
D003376 Counseling The giving of advice and assistance to individuals with educational or personal problems.
D003718 Denmark A country in northern Europe, bordering the Baltic Sea and the North Sea. The capital is Copenhagen. Faeroe Islands,Faroe Islands

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