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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Active Commuting To Improve Well-being and Health in Everyday Life

Resource links provided by NLM:


Further study details as provided by 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 ] [ 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)


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


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

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01962259

Contacts
Contact: Mads Rosenkilde, PhD +45 26175847 madsrl@sund.ku.dk
Contact: Bente M Stallknecht, MD +45 35327540 bstall@sund.ku.dk

Locations
Denmark
University of Copenhagen, Department of Biomedical Sciences Recruiting
Copenhagen, Denmark, 2200
Contact: Mads Rosenkilde, PhD    +4526175847    madsrl@sund.ku.dk   
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:
No publications provided

Responsible Party: Bente Merete Stallknecht, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01962259     History of Changes
Other Study ID Numbers: ACTIWE-1
Study First Received: September 25, 2013
Last Updated: May 8, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014