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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Bente Merete Stallknecht, University of Copenhagen.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01962259
First Posted: October 14, 2013
Last Update Posted: October 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Copenhagen University Hospital, Denmark
Information provided by (Responsible Party):
Bente Merete Stallknecht, University of Copenhagen
  Purpose

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


Condition Intervention
Overweight and Obesity Behavioral: Physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Active Commuting To Improve Well-being and Health in Everyday Life

Further study details as provided by Bente Merete Stallknecht, University of Copenhagen:

Primary Outcome Measures:
  • 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

  • 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 3 months ]
    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 ]
    Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)


Secondary Outcome Measures:
  • Glycaemic control [ Time Frame: 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

  • Central insulin sensitivity [ Time Frame: 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) [ Time Frame: Baseline, 3 and 6 months ]
    Measured using indirect calorimetry and an incremental bicycle protocol

  • Abdominal fat mass [ Time Frame: Baseline, 3 and 6 months ]
    Visceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging

  • Metabolic syndrome [ Time Frame: 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

  • Haemostatic balance II [ Time Frame: 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.

  • Health related quality of life and other psycho-social outcomes [ Time Frame: Baseline, 3 and 6 months ]
    Measured using questionaries (SF-36), semi-structured interviews and observations

  • Anthropometry [ Time Frame: Baseline, 3 and 6 months ]
    Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height

  • Sleep habits [ Time Frame: Baseline, 3 and 6 months ]
    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 ]
    Biochemical, proteomics, metabolomics, genomics and morphological analyses

  • Subcutaneous adipose tissue biopsy [ Time Frame: Baseline, 3 and 6 months ]
    Biochemical, proteomics, metabolomics, genomics and morphological analyses


Other Outcome Measures:
  • Exercise compliance [ Time Frame: Baseline, 3 and 6 month ]
    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


Estimated Enrollment: 175
Study Start Date: October 2013
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
Behavioral: Physical activity
No Intervention: Control
Receives no intervention.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962259


Locations
Denmark
University of Copenhagen, Department of Biomedical Sciences
Copenhagen, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
Copenhagen University Hospital, Denmark
Investigators
Principal Investigator: Bente M Stallknecht, MD,PHD,DMSc University of Copenhagen, Department of Biomedical Sciences
  More Information

Additional Information:
Responsible Party: Bente Merete Stallknecht, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01962259     History of Changes
Other Study ID Numbers: ACTIWE-1
First Submitted: September 25, 2013
First Posted: October 14, 2013
Last Update Posted: October 20, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms