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

Overweight and Obesity Clinical Trial

— GO-ACTIWE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962259
• Other study ID #: ACTIWE-1
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: July 2017

Study information

• Verified date: July 2018
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: July 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Physical activity

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Department of Biomedical Sciences	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Copenhagen University Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exercise compliance	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
Primary	Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)	Measured using the hyper-insulinemic euglycaemic clamp	Change from baseline in peripheral insulin sensitivity at 3 months
Primary	Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)	Measured using the hyper-insulinemic euglycaemic clamp	Change from baseline in peripheral insulin sensitivity at 6 months
Primary	Haemostatic balance	Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)	Change from baseline in endogenous thrombin potential at 3 months
Primary	Haemostatic balance	Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)	Change from baseline in endogenous thrombin potential at 6 months
Secondary	Glycaemic control	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
Secondary	Central insulin sensitivity	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
Secondary	Maximal oxygen uptake (ml/O2/kg/min)	Measured using indirect calorimetry and an incremental bicycle protocol	Baseline, 3 and 6 months
Secondary	Abdominal fat mass	Visceral intrabdominal and subcutaneous fat mass determined by magnetic resonance imaging	Baseline, 3 and 6 months
Secondary	Metabolic syndrome	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
Secondary	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.	Baseline, 3 and 6 months
Secondary	Health related quality of life and other psycho-social outcomes	Measured using questionaries (SF-36), semi-structured interviews and observations	Baseline, 3 and 6 months
Secondary	Anthropometry	Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height	Baseline, 3 and 6 months
Secondary	Sleep habits	Sleep duration and quality measured using accelerometers, logs and questionaires (Pittsburgh sleep quality index and Epworth sleepiness scale)	Baseline, 3 and 6 months
Secondary	Skeletal muscle biopsy	Biochemical, proteomics, metabolomics, genomics and morphological analyses	Baseline, 3 and 6 months
Secondary	Subcutaneous adipose tissue biopsy	Biochemical, proteomics, metabolomics, genomics and morphological analyses	Baseline, 3 and 6 months

External Links

•   Project homepage