Active Commuting To Improve Well-being and Health in Everyday Life

Study Overview
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Brief Summary
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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

Official Title
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Active Commuting To Improve Well-being and Health in Everyday Life

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vigorous intensity LTPA<br>Leisure time physical activity (LTPA): Exercise intensity: 70% of maximal oxygen uptake (VO2 max); Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week | Behavioral: Physical activity<br> <br> |
| Experimental: Moderate intensity LTPA<br>Leisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week | Behavioral: Physical activity<br> <br> |
| Experimental: Active commuting<br>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 | Behavioral: Physical activity<br> <br> |
| No Intervention: Control<br>Receives no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin) | Measured using the hyper-insulinemic euglycaemic clamp | Change from baseline in peripheral insulin sensitivity at 3 months | 
| Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin) | Measured using the hyper-insulinemic euglycaemic clamp | Change from baseline in peripheral insulin sensitivity at 6 months | 
| Haemostatic balance | Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min) | Change from baseline in endogenous thrombin potential at 3 months | 
| Haemostatic balance | Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min) | Change from baseline in endogenous thrombin potential at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic control | Fasting plasma glucose, 1- and 2-hour plasma glucose and glucose area under the curve measured during an oral glucose tolerance test | Baseline, 3 and 6 months | 
| Central insulin sensitivity | Fasting plasma insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test | Baseline, 3 and 6 months | 
| Maximal oxygen uptake (ml/O2/kg/min) | Measured using indirect calorimetry and an incremental bicycle protocol | Baseline, 3 and 6 months | 
| Abdominal fat mass | Visceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging | Baseline, 3 and 6 months | 
| Metabolic syndrome | As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores | Baseline, 3 and 6 months | 
| Haemostatic balance II | 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. | Baseline, 3 and 6 months | 
| Health related quality of life and other psycho-social outcomes | Measured using questionaries (SF-36), semi-structured interviews and observations | Baseline, 3 and 6 months | 
| Anthropometry | Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height | Baseline, 3 and 6 months | 
| Sleep habits | Sleep duration and quality measured using accelerometers, logs and questionaires (Pittsburgh sleep quality index and Epworth sleepiness scale) | Baseline, 3 and 6 months | 
| Skeletal muscle biopsy | Biochemical, proteomics, metabolomics, genomics and morphological analyses | Baseline, 3 and 6 months | 
| Subcutaneous adipose tissue biopsy | Biochemical, proteomics, metabolomics, genomics and morphological analyses | Baseline, 3 and 6 months |