Active Commuting To Improve Well-being and Health in Everyday Life
- Conditions
- Overweight and Obesity
- Interventions
- Behavioral: Physical activity
- Registration Number
- NCT01962259
- Lead Sponsor
- University of Copenhagen
- Brief Summary
The aim of present randomized controlled trial is to evaluate the health effects of physical activity in transport and leisure time domains of everyday life and to develop durable physical activity regimens, i.e. to go from lifestyle intervention to daily lifestyle routine, in overweight individuals.
Subjects will be randomized to 1 of 4 groups. 1: Vigorous intensity leisure time physical activity, 2: Moderate intensity leisure time activity, 3: Active commuting by bicycle, or 4: a non-intervention control group
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 188
- Healthy
- No engagement in habitual structured physical activity
- Body mass index 25-35 kg/m2
- Body fat percentage >32% for women and >25% for men
- Maximum oxygen uptake (VO2max) <40 ml O2/kg/min for women and <45 ml O2/kg/min for men
- Ethnicity: Caucasian
- Chronic use of medicine
- Smoking
- Fasting plasma glucose > 6,1 mmol/L
- Blood pressure > 140/90 mm Hg
- Abnormal resting and working ECG
- Parents or siblings with diagnosed type 2 diabetes
- For women: Follicle stimulating hormone (FSH) concentration > 35 milliunits/ml, pregnancy or planning of pregnancy within the coming year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate intensity LTPA Physical activity Leisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week Vigorous intensity LTPA Physical activity Leisure time physical activity (LTPA): Exercise intensity: 70% of maximal oxygen uptake (VO2 max); Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week Active commuting Physical activity Bicycling to/from work/school/university. No requirements for exercise intensity; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week; Avg distance per day Females 9-15 km; Males 11-17 km
- Primary Outcome Measures
Name Time Method Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin) Change from baseline in peripheral insulin sensitivity at 6 months Measured using the hyper-insulinemic euglycaemic clamp
Haemostatic balance Change from baseline in endogenous thrombin potential at 6 months Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)
- Secondary Outcome Measures
Name Time Method Subcutaneous adipose tissue biopsy Baseline, 3 and 6 months Biochemical, proteomics, metabolomics, genomics and morphological analyses
Glycaemic control Baseline, 3 and 6 months Fasting plasma glucose, 1- and 2-hour plasma glucose and glucose area under the curve measured during an oral glucose tolerance test
Abdominal fat mass Baseline, 3 and 6 months Visceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging
Health related quality of life and other psycho-social outcomes Baseline, 3 and 6 months Measured using questionaries (SF-36), semi-structured interviews and observations
Anthropometry Baseline, 3 and 6 months Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height
Sleep habits Baseline, 3 and 6 months Sleep duration and quality measured using accelerometers, logs and questionaires (Pittsburgh sleep quality index and Epworth sleepiness scale)
Haemostatic balance II Baseline, 3 and 6 months 1: Coagulation: Fibrinogen, Tissue factor(TF), prothrombin fragment 1+2. 2: Fibrinolysis: Tissue type plasminogen activator(tPA:AG), Plasminogen activator inhibitor type 1(PAI-1:AG). 3: Endothelial cell function: von Willebrand factor(vWF), Tissue factor pathway inhibitor (TFPI). 4: Inflammation: C-Reactive protein.
Metabolic syndrome Baseline, 3 and 6 months As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores
Central insulin sensitivity Baseline, 3 and 6 months Fasting plasma insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test
Maximal oxygen uptake (ml/O2/kg/min) Baseline, 3 and 6 months Measured using indirect calorimetry and an incremental bicycle protocol
Skeletal muscle biopsy Baseline, 3 and 6 months Biochemical, proteomics, metabolomics, genomics and morphological analyses
Trial Locations
- Locations (1)
University of Copenhagen, Department of Biomedical Sciences
🇩🇰Copenhagen, Denmark