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CompletedNCT01973686Updated Aug 2, 2018

GO-ACTIWE Energy Metabolism

An interventional study of Physical activity in Overweight and Obesity, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-02.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
188
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
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Study summary

The aim of the present study is to investigate the changes in body composition and the degree of compensation to exercise induced energy expenditure after 1 year of physical activity with either moderate or vigorous intensity in overweight and class 1 obese men and women. The present study is a sub study to main study "Active Commuting To Improve Well-being and Health in Everyday Life" (NCT 01962259)

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Conditions studied

  • Overweight and Obesity

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03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 188 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

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Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Participation in main study (NCT 01962259)

Exclusion criteria

Exclusion Criteria:

  • No participation in main study
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
188 participants (actual)

Study arms

  • 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

  • No intervention
    Control

    Receives no intervention

Interventions

  • BehavioralPhysical activity
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What researchers measure

Primary outcomes

  1. Total body fat

    Changes in total body fat (kg) measured by dual x-ray absorptiometry

    Time frame: Change from baseline in body fat at 3 months

  2. Total body fat

    Changes in total body fat (kg) measured by dual x-ray absorptiometry

    Time frame: Change from baseline in body fat at 6 months

Secondary outcomes

  1. Net energy balance and degree of compensation

    1. Net energy balance calculated from changes in body composition, and 2. the degree of compensation as the difference between energy spent during exercise and net energy balance

    Time frame: 3 and 6 months

  2. Compensatory mechanisms

    1. Resting metabolic rate determined by indirect calorimetry, 2. Total physical activity (TPA) measured using accelerometry, 3. Non-exercise activity determined as the difference between TPA and exercise activity, and 4. Energy intake determined by food records and during meal tests

    Time frame: Baseline, 3 and 6 months

  3. Appetite control

    Appetite control determined via 1. blood samples (peptides and metabolites) and 2. self rated sensations (visual analogue scales) in relation with standardized meals and exercise, as well as 3. ad libitum energy intake and 4. Eating behaviours determined via three-factor eating questionaire

    Time frame: Baseline, 3 and 6 months

  4. Anthropometry

    Body composition measured by dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height

    Time frame: Baseline, 3 and 6 months

Other outcomes

  1. Exercise compliance and energy expenditure

    Exercise compliance and energy expenditure will be measured and adjusted continuously with the use of heart rate monitors over the course of the 1 year intervention

    Time frame: Baseline, 3 and 6 month

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Study locations

1 site
  • University of Copenhagen, Department of Biomedical Sciences
    Copenhagen, 2200, Denmark
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References and documents

Publications

  • 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01973686
Lead sponsor
University of Copenhagen
Responsible party
Bente Merete Stallknecht (Professor, University of Copenhagen) — Principal investigator
First posted
Oct 31, 2013
Start date
Nov 2013
Primary completion
Jun 2016
Completion
Jul 2017
Last update
Aug 2, 2018

Study contacts

Bente M Stallknecht, MD PhD DMSc
principal investigator · Professor

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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