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

July 31, 2018 updated by: Bente Merete Stallknecht, University of Copenhagen

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2200
        • University of Copenhagen, Department of Biomedical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline in peripheral insulin sensitivity at 3 months
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
Change from baseline in peripheral insulin sensitivity at 6 months
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)
Change from baseline in endogenous thrombin potential at 3 months
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)
Change from baseline in endogenous thrombin potential at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 3 and 6 months
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
Baseline, 3 and 6 months
Maximal oxygen uptake (ml/O2/kg/min)
Time Frame: Baseline, 3 and 6 months
Measured using indirect calorimetry and an incremental bicycle protocol
Baseline, 3 and 6 months
Abdominal fat mass
Time Frame: Baseline, 3 and 6 months
Visceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging
Baseline, 3 and 6 months
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
Baseline, 3 and 6 months
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.
Baseline, 3 and 6 months
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
Baseline, 3 and 6 months
Anthropometry
Time Frame: Baseline, 3 and 6 months
Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height
Baseline, 3 and 6 months
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)
Baseline, 3 and 6 months
Skeletal muscle biopsy
Time Frame: Baseline, 3 and 6 months
Biochemical, proteomics, metabolomics, genomics and morphological analyses
Baseline, 3 and 6 months
Subcutaneous adipose tissue biopsy
Time Frame: Baseline, 3 and 6 months
Biochemical, proteomics, metabolomics, genomics and morphological analyses
Baseline, 3 and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 3 and 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Copenhagen University Hospital, Denmark

Investigators

  • Principal Investigator: Bente M Stallknecht, MD,PHD,DMSc, University of Copenhagen, Department of Biomedical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimate)

October 14, 2013

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTIWE-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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