Active Commuting To Improve Well-being and Health in Everyday Life
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 188
- Locations
- 1
- Primary Endpoint
- Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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
Arms & Interventions
Control
Receives no intervention.
Vigorous intensity LTPA
Leisure time physical activity (LTPA): Exercise intensity: 70% of maximal oxygen uptake (VO2 max); Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week
Intervention: Physical activity (Behavioral)
Moderate intensity LTPA
Leisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week
Intervention: Physical activity (Behavioral)
Active commuting
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
Intervention: Physical activity (Behavioral)
Outcomes
Primary Outcomes
Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
Time Frame: Change from baseline in peripheral insulin sensitivity at 6 months
Measured using the hyper-insulinemic euglycaemic clamp
Haemostatic balance
Time Frame: Change from baseline in endogenous thrombin potential at 6 months
Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)
Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
Time Frame: Change from baseline in peripheral insulin sensitivity at 3 months
Measured using the hyper-insulinemic euglycaemic clamp
Haemostatic balance
Time Frame: Change from baseline in endogenous thrombin potential at 3 months
Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)
Secondary Outcomes
- Abdominal fat mass(Baseline, 3 and 6 months)
- Health related quality of life and other psycho-social outcomes(Baseline, 3 and 6 months)
- Anthropometry(Baseline, 3 and 6 months)
- Sleep habits(Baseline, 3 and 6 months)
- Subcutaneous adipose tissue biopsy(Baseline, 3 and 6 months)
- Glycaemic control(Baseline, 3 and 6 months)
- Haemostatic balance II(Baseline, 3 and 6 months)
- Metabolic syndrome(Baseline, 3 and 6 months)
- Central insulin sensitivity(Baseline, 3 and 6 months)
- Maximal oxygen uptake (ml/O2/kg/min)(Baseline, 3 and 6 months)
- Skeletal muscle biopsy(Baseline, 3 and 6 months)
Investigators
Bente Merete Stallknecht
Professor
University of Copenhagen