search
Back to results

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

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Physical activity
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight and Obesity

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Copenhagen, Department of Biomedical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Vigorous intensity LTPA

Moderate intensity LTPA

Active commuting

Control

Arm Description

Leisure time physical activity (LTPA): Exercise intensity: 70% of maximal oxygen uptake (VO2 max); Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week

Leisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week

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

Receives no intervention.

Outcomes

Primary Outcome Measures

Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
Measured using the hyper-insulinemic euglycaemic clamp
Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
Measured using the hyper-insulinemic euglycaemic clamp
Haemostatic balance
Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)
Haemostatic balance
Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)

Secondary Outcome Measures

Glycaemic control
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
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)
Measured using indirect calorimetry and an incremental bicycle protocol
Abdominal fat mass
Visceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging
Metabolic syndrome
As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores
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.
Health related quality of life and other psycho-social outcomes
Measured using questionaries (SF-36), semi-structured interviews and observations
Anthropometry
Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height
Sleep habits
Sleep duration and quality measured using accelerometers, logs and questionaires (Pittsburgh sleep quality index and Epworth sleepiness scale)
Skeletal muscle biopsy
Biochemical, proteomics, metabolomics, genomics and morphological analyses
Subcutaneous adipose tissue biopsy
Biochemical, proteomics, metabolomics, genomics and morphological analyses

Full Information

First Posted
September 25, 2013
Last Updated
July 31, 2018
Sponsor
University of Copenhagen
Collaborators
Copenhagen University Hospital, Denmark
search

1. Study Identification

Unique Protocol Identification Number
NCT01962259
Brief Title
Active Commuting To Improve Well-being and Health in Everyday Life
Acronym
GO-ACTIWE
Official Title
Active Commuting To Improve Well-being and Health in Everyday Life
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Copenhagen University Hospital, Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vigorous intensity LTPA
Arm Type
Experimental
Arm Description
Leisure time physical activity (LTPA): Exercise intensity: 70% of maximal oxygen uptake (VO2 max); Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week
Arm Title
Moderate intensity LTPA
Arm Type
Experimental
Arm Description
Leisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week
Arm Title
Active commuting
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Receives no intervention.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Primary Outcome Measure Information:
Title
Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
Description
Measured using the hyper-insulinemic euglycaemic clamp
Time Frame
Change from baseline in peripheral insulin sensitivity at 3 months
Title
Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
Description
Measured using the hyper-insulinemic euglycaemic clamp
Time Frame
Change from baseline in peripheral insulin sensitivity at 6 months
Title
Haemostatic balance
Description
Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)
Time Frame
Change from baseline in endogenous thrombin potential at 3 months
Title
Haemostatic balance
Description
Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)
Time Frame
Change from baseline in endogenous thrombin potential at 6 months
Secondary Outcome Measure Information:
Title
Glycaemic control
Description
Fasting plasma glucose, 1- and 2-hour plasma glucose and glucose area under the curve measured during an oral glucose tolerance test
Time Frame
Baseline, 3 and 6 months
Title
Central insulin sensitivity
Description
Fasting plasma insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test
Time Frame
Baseline, 3 and 6 months
Title
Maximal oxygen uptake (ml/O2/kg/min)
Description
Measured using indirect calorimetry and an incremental bicycle protocol
Time Frame
Baseline, 3 and 6 months
Title
Abdominal fat mass
Description
Visceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging
Time Frame
Baseline, 3 and 6 months
Title
Metabolic syndrome
Description
As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores
Time Frame
Baseline, 3 and 6 months
Title
Haemostatic balance II
Description
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.
Time Frame
Baseline, 3 and 6 months
Title
Health related quality of life and other psycho-social outcomes
Description
Measured using questionaries (SF-36), semi-structured interviews and observations
Time Frame
Baseline, 3 and 6 months
Title
Anthropometry
Description
Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height
Time Frame
Baseline, 3 and 6 months
Title
Sleep habits
Description
Sleep duration and quality measured using accelerometers, logs and questionaires (Pittsburgh sleep quality index and Epworth sleepiness scale)
Time Frame
Baseline, 3 and 6 months
Title
Skeletal muscle biopsy
Description
Biochemical, proteomics, metabolomics, genomics and morphological analyses
Time Frame
Baseline, 3 and 6 months
Title
Subcutaneous adipose tissue biopsy
Description
Biochemical, proteomics, metabolomics, genomics and morphological analyses
Time Frame
Baseline, 3 and 6 months
Other Pre-specified Outcome Measures:
Title
Exercise compliance
Description
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
Time Frame
Baseline, 3 and 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bente M Stallknecht, MD,PHD,DMSc
Organizational Affiliation
University of Copenhagen, Department of Biomedical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen, Department of Biomedical Sciences
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
31467422
Citation
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.
Results Reference
derived
PubMed Identifier
31089425
Citation
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.
Results Reference
derived
PubMed Identifier
30878970
Citation
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.
Results Reference
derived
PubMed Identifier
28993707
Citation
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.
Results Reference
derived
PubMed Identifier
28679486
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs