Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on bodyweight in overweight and obese subjects after an initial weight loss.
DiOGenes is a randomised controlled dietary intervention study in obese/overweight families (adults and children) in 8 different European countries, testing the efficacy and safety of diets differing in Glycaemic Index (GI) and protein content. The 8 centres are divided into "shop centers" and "instruction centers", that provide different kind of dietary intervention and for a different length(see below): The 2 Shop Centers (Denmark \& The Netherlands): Dietary periods and clinical examinations: 1. Clinical examination 1 with anthropometry, blood etc. 2. 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day)(Adults only) 3. Clinical examination 2 with anthropometry, blood etc. 4. 6 months dietary intervention period 1 (SUPERMARKET period)(Family) 5. Clinical examination 3 with anthropometry, blood etc. 6. 6 months dietary intervention period 2 (DIETARY INSTRUCTION period)(Family). 7. Clinical examination 4 with anthropometry, blood ect. 8. 12 months free-living period with no dietary intervention. (Family) 9. Follow up (only body weight registration) The 6 Instruction Centers (UK, Crete, Germany, Spain, Bulgaria, Czech Republic) Dietary periods and clinical examinations: 1. Clinical examination 1 with anthropometry, blood etc. 2. 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day). (Adults only) 3. Clinical examination 2 with anthropometry, blood etc. 4. 6 months dietary intervention period (DIETARY INSTRUCTION period). (Family) 5. Clinical examination 3 with anthropometry, blood etc. 6. 6 months free-living period with no dietary intervention. (Family) 7. Follow up (only body weight registration) Note that, during the first 6 month intervention all families from the shop centers are provided all foods free of charge "SUPERMARKET PERIOD", whereas in the "Instruction Centers", the families receive dietary instruction only "Instruction Only".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,020
Arne V. Astrup
Copenhagen, Denmark
For adults: body weight loss maintenance
The primary outcome is related to body weight loss maintenance after 6 month of intensive, homogeneous and therefore comparable dietary intervention across all 8 centres.
Time frame: 6 Month
For adults: change in body composition
The relative loss or gain of fat mass and fat free mass
Time frame: 6 Month
For adults: More than 5% weight loss maintenance
Achievement of 5% of body weight loss from randomization
Time frame: 6 month
For adults: More than 10% weight loss maintenance
Achievement of 10% of body weight loss from randomization
Time frame: 6 month
For adults: Drop out rate
Percentage drop out from randomisation to end of dietary intervention
Time frame: 6 month
For Adults: Change in risk factors for type-2 diabetes
Change in risk factors for type-2 diabetes
Time frame: 6 month
For Adults: Change in risk factors for cardiovascular disease
Change in risk factors for cardiovascular disease
Time frame: 6 month
For children: Change in body weight
Change in body weight from randomization to end of intervention
Time frame: 6 month
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For Children: Change in BMI-Z-score
Change in BMI-Z-score from randomisation to end of intervention
Time frame: 6 month