Overview

This trial is active, not recruiting.

Condition overweight and obesity
Treatment physical activity
Sponsor University of Copenhagen
Collaborator Copenhagen University Hospital, Denmark
Start date October 2013
End date October 2015
Trial size 175 participants
Trial identifier NCT01962259, ACTIWE-1

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Leisure time physical activity (LTPA): Exercise intensity: 70% of maximal oxygen uptake (VO2 max); Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week
physical activity
(Experimental)
Leisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week
physical activity
(Experimental)
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
physical activity
(No Intervention)
Receives no intervention.

Primary Outcomes

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
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
Haemostatic balance
time frame: Change from baseline in endogenous thrombin potential at 3 months
Haemostatic balance
time frame: Change from baseline in endogenous thrombin potential at 6 months

Secondary Outcomes

Measure
Glycaemic control
time frame: Baseline, 3 and 6 months
Central insulin sensitivity
time frame: Baseline, 3 and 6 months
Maximal oxygen uptake (ml/O2/kg/min)
time frame: Baseline, 3 and 6 months
Abdominal fat mass
time frame: Baseline, 3 and 6 months
Metabolic syndrome
time frame: Baseline, 3 and 6 months
Haemostatic balance II
time frame: Baseline, 3 and 6 months
Health related quality of life and other psycho-social outcomes
time frame: Baseline, 3 and 6 months
Anthropometry
time frame: Baseline, 3 and 6 months
Sleep habits
time frame: Baseline, 3 and 6 months
Skeletal muscle biopsy
time frame: Baseline, 3 and 6 months
Subcutaneous adipose tissue biopsy
time frame: Baseline, 3 and 6 months

Eligibility Criteria

Male or female participants from 20 years up to 45 years old.

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

Additional Information

Official title Active Commuting To Improve Well-being and Health in Everyday Life
Principal investigator Bente M Stallknecht, MD,PHD,DMSc
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Copenhagen.