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Overweight and ObesityGO-ACTIWENCT01962259

Active Commuting To Improve Well-being and Health in Everyday Life

A study testing Physical activity in people with Overweight and Obesity, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
Physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
1 siteDenmark
Study dates
Nov 2013to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • University of Copenhagen, Department of Biomedical Sciences

    Copenhagen, 2200

Other trials in Denmark

About this study

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

Being tested
Physical activity
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01962259
Study groupRoleWhat they receive
Vigorous intensity LTPAExperimentalLeisure time physical activity (LTPA): Exercise intensity: 70% of maximal oxygen uptake (VO2 max); Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week
Receives: Behavioral: Physical activity
Moderate intensity LTPAExperimentalLeisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week
Receives: Behavioral: Physical activity
Active commutingExperimentalBicycling 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
Receives: Behavioral: Physical activity
ControlNo interventionReceives no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)

    Measured using the hyper-insulinemic euglycaemic clamp

    Measured: Change from baseline in peripheral insulin sensitivity at 3 months

  2. Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)

    Measured using the hyper-insulinemic euglycaemic clamp

    Measured: Change from baseline in peripheral insulin sensitivity at 6 months

  3. Haemostatic balance

    Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)

    Measured: Change from baseline in endogenous thrombin potential at 3 months

  4. Haemostatic balance

    Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)

    Measured: Change from baseline in endogenous thrombin potential at 6 months

Secondary outcomes (11)

  1. Glycaemic control

    Fasting plasma glucose, 1- and 2-hour plasma glucose and glucose area under the curve measured during an oral glucose tolerance test

    Measured: Baseline, 3 and 6 months

  2. Central insulin sensitivity

    Fasting plasma insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test

    Measured: Baseline, 3 and 6 months

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

    Measured using indirect calorimetry and an incremental bicycle protocol

    Measured: Baseline, 3 and 6 months

  4. Abdominal fat mass

    Visceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging

    Measured: Baseline, 3 and 6 months

  5. Metabolic syndrome

    As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores

    Measured: Baseline, 3 and 6 months

  6. Haemostatic balance II

    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.

    Measured: Baseline, 3 and 6 months

  7. Health related quality of life and other psycho-social outcomes

    Measured using questionaries (SF-36), semi-structured interviews and observations

    Measured: Baseline, 3 and 6 months

  8. Anthropometry

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

    Measured: Baseline, 3 and 6 months

  9. Sleep habits

    Sleep duration and quality measured using accelerometers, logs and questionaires (Pittsburgh sleep quality index and Epworth sleepiness scale)

    Measured: Baseline, 3 and 6 months

  10. Skeletal muscle biopsy

    Biochemical, proteomics, metabolomics, genomics and morphological analyses

    Measured: Baseline, 3 and 6 months

  11. Subcutaneous adipose tissue biopsy

    Biochemical, proteomics, metabolomics, genomics and morphological analyses

    Measured: Baseline, 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionJun 2016
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01962259
Sponsor's protocol ID
ACTIWE-1
Acronym
GO-ACTIWE
Status last verified
Jul 2018
First submitted
25 Sep 2013
Last updated
2 Aug 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Kern T, Blond MB, Hansen TH, Rosenkilde M, Quist JS, Gram AS, Ekstrom CT, Hansen T, Stallknecht B. Structured exercise alters the gut microbiota in humans with overweight and obesity-A randomized controlled trial. Int J Obes (Lond). 2020 Jan;44(1):125-135. doi: 10.1038/s41366-019-0440-y. Epub 2019 Aug 29.

    PubMed 31467422

  • Quist JS, Rosenkilde M, Gram AS, Blond MB, Holm-Petersen D, Hjorth MF, Stallknecht B, Sjodin A. Effects of Exercise Domain and Intensity on Sleep in Women and Men with Overweight and Obesity. J Obes. 2019 Apr 7;2019:2189034. doi: 10.1155/2019/2189034. eCollection 2019.

    PubMed 31089425

  • Blond MB, Rosenkilde M, Gram AS, Tindborg M, Christensen AN, Quist JS, Stallknecht BM. How does 6 months of active bike commuting or leisure-time exercise affect insulin sensitivity, cardiorespiratory fitness and intra-abdominal fat? A randomised controlled trial in individuals with overweight and obesity. Br J Sports Med. 2019 Sep;53(18):1183-1192. doi: 10.1136/bjsports-2018-100036. Epub 2019 Mar 16.

    PubMed 30878970

  • Quist JS, Rosenkilde M, Petersen MB, Gram AS, Sjodin A, Stallknecht B. Effects of active commuting and leisure-time exercise on fat loss in women and men with overweight and obesity: a randomized controlled trial. Int J Obes (Lond). 2018 Mar;42(3):469-478. doi: 10.1038/ijo.2017.253. Epub 2017 Oct 10.

    PubMed 28993707

  • Gram AS, Bladbjerg EM, Quist JS, Petersen MB, Rosenkilde M, Stallknecht B. Anti-inflammatory effects of active commuting and leisure time exercise in overweight and obese women and men: A randomized controlled trial. Atherosclerosis. 2017 Oct;265:318-324. doi: 10.1016/j.atherosclerosis.2017.06.923. Epub 2017 Jun 28.

    PubMed 28679486

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity in people with Overweight and Obesity, run by University of Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01962259, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.

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