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Active Commuting To Improve Well-being and Health in Everyday Life (GO-ACTIWE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Copenhagen
Sponsor:
Collaborator:
Copenhagen University Hospital, Denmark
Information provided by (Responsible Party):
Bente Merete Stallknecht, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01962259
First received: September 25, 2013
Last updated: May 8, 2014
Last verified: May 2014

September 25, 2013
May 8, 2014
October 2013
October 2015   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    Measured using the hyper-insulinemic euglycaemic clamp
  • 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 ] [ Designated as safety issue: No ]
    Measured using the hyper-insulinemic euglycaemic clamp
  • Haemostatic balance [ Time Frame: Change from baseline in endogenous thrombin potential at 3 months ] [ Designated as safety issue: No ]
    Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)
  • Haemostatic balance [ Time Frame: Change from baseline in endogenous thrombin potential at 6 months ] [ Designated as safety issue: No ]
    Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)
Same as current
Complete list of historical versions of study NCT01962259 on ClinicalTrials.gov Archive Site
  • Glycaemic control [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    Fasting plasma glucose, 1- and 2-hour plasma glucose and glucose area under the curve measured during an oral glucose tolerance test
  • Central insulin sensitivity [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    Measured using indirect calorimetry and an incremental bicycle protocol
  • Abdominal fat mass [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    Visceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging
  • Metabolic syndrome [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores
  • Haemostatic balance II [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    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.
  • Health related quality of life and other psycho-social outcomes [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    Measured using questionaries (SF-36), semi-structured interviews and observations
  • Anthropometry [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height
  • Sleep habits [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    Sleep duration and quality measured using accelerometers, logs and questionaires (Pittsburgh sleep quality index and Epworth sleepiness scale)
  • Skeletal muscle biopsy [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    Biochemical, proteomics, metabolomics, genomics and morphological analyses
  • Subcutaneous adipose tissue biopsy [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: No ]
    Biochemical, proteomics, metabolomics, genomics and morphological analyses
  • Glycaemic control [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    Fasting plasma glucose, 1- and 2-hour plasma glucose and glucose area under the curve measured during an oral glucose tolerance test
  • Central insulin sensitivity [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    Measured using indirect calorimetry and an incremental bicycle protocol
  • Abdominal fat mass [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    Visceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging
  • Metabolic syndrome [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores
  • Haemostatic balance II [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    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.
  • Health related quality of life and other psycho-social outcomes [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    Measured using questionaries (SF-36), semi-structured interviews and observations
  • Anthropometry [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height
  • Sleep habits [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    Sleep duration and quality measured using accelerometers, logs and questionaires (Pittsburgh sleep quality index and Epworth sleepiness scale)
  • Skeletal muscle biopsy [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    Biochemical, proteomics, metabolomics, genomics and morphological analyses
  • Subcutaneous adipose tissue biopsy [ Time Frame: Baseline, 3 and 12 months ] [ Designated as safety issue: No ]
    Biochemical, proteomics, metabolomics, genomics and morphological analyses
Exercise compliance [ Time Frame: Baseline, 3 and 6 month ] [ Designated as safety issue: Yes ]
Adherence to the exercise protocol as measured using heart rate and global positioning system monitors will be assessed and individually adjusted continuously over the course of the exercise intervention
Exercise compliance [ Time Frame: Baseline, 3 and 12 month ] [ Designated as safety issue: Yes ]
Adherence to the exercise protocol as measured using heart rate and global positioning system monitors will be assessed and individually adjusted continuously over the course of the exercise intervention
 
Active Commuting To Improve Well-being and Health in Everyday Life
Active Commuting To Improve Well-being and Health in Everyday Life

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Overweight and Obesity
Behavioral: Physical activity
  • Experimental: 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: Behavioral: Physical activity
  • Experimental: Moderate intensity LTPA
    Leisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week
    Intervention: Behavioral: Physical activity
  • Experimental: 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: Behavioral: Physical activity
  • No Intervention: Control
    Receives no intervention.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
175
Not Provided
October 2015   (final data collection date for primary outcome measure)

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
Both
20 Years to 45 Years
Yes
Contact: Mads Rosenkilde, PhD +45 26175847 madsrl@sund.ku.dk
Contact: Bente M Stallknecht, MD +45 35327540 bstall@sund.ku.dk
Denmark
 
NCT01962259
ACTIWE-1
Yes
Bente Merete Stallknecht, University of Copenhagen
University of Copenhagen
Copenhagen University Hospital, Denmark
Principal Investigator: Bente M Stallknecht, MD,PHD,DMSc University of Copenhagen, Department of Biomedical Sciences
University of Copenhagen
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP