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Completed

NCT Number: NCT01962259

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

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen, Department of Biomedical Sciences

Copenhagen, 2200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

Primary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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 outcomes

  1. 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

  2. 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

  3. Maximal oxygen uptake (ml/O2/kg/min)

    Time frame: Baseline, 3 and 6 months

    Measured using indirect calorimetry and an incremental bicycle protocol

  4. Abdominal fat mass

    Time frame: Baseline, 3 and 6 months

    Visceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging

  5. 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

  6. 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.

  7. 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

  8. Anthropometry

    Time frame: Baseline, 3 and 6 months

    Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height

  9. 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)

  10. Skeletal muscle biopsy

    Time frame: Baseline, 3 and 6 months

    Biochemical, proteomics, metabolomics, genomics and morphological analyses

  11. Subcutaneous adipose tissue biopsy

    Time frame: Baseline, 3 and 6 months

    Biochemical, proteomics, metabolomics, genomics and morphological analyses

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Copenhagen University Hospital, Denmark

Registry information

Acronym: GO-ACTIWE

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Oct 14, 2013
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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