Overweight and ObesityNCT01973686
GO-ACTIWE Energy Metabolism
A study testing Physical activity in people with Overweight and Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial 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. 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
- Type of treatment
- Lifestyle or therapy programme
- 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
- Participation in main study (NCT 01962259)
Who cannot join
- No participation in main study
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Copenhagen, Department of Biomedical Sciences
Copenhagen, 2200
About this study
Official title: Active Commuting To Improve Well-being and Health in Everyday Life (ACTIWE)
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)
- Conditions
- Overweight and Obesity
- 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.
Physical activityBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Vigorous intensity LTPA | 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 Receives: Behavioral: Physical activity |
| Moderate intensity LTPA | Experimental | Leisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week Receives: Behavioral: Physical activity |
| Control | No intervention | Receives no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body fat
Changes in total body fat (kg) measured by dual x-ray absorptiometry
Measured: Change from baseline in body fat at 3 months
Total body fat
Changes in total body fat (kg) measured by dual x-ray absorptiometry
Measured: Change from baseline in body fat at 6 months
Secondary outcomes (4)
Net energy balance and degree of compensation
- 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
Measured: 3 and 6 months
Compensatory mechanisms
- 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
Measured: Baseline, 3 and 6 months
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
Measured: Baseline, 3 and 6 months
Anthropometry
Body composition measured by dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height
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.
- First posted31 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bente Merete Stallknecht, University of Copenhagen
- Investigators
- Bente M Stallknecht, MD PhD DMSc, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973686
- Sponsor's protocol ID
- ACTIWE-2
- Status last verified
- Jul 2018
- First submitted
- 21 Oct 2013
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Commuting To Improve Well-being and Health in Everyday Life (ACTIWE)
- ClinicalTrials.gov ID
- NCT01973686
- Acronym / sponsor ID
- ACTIWE-2
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vigorous intensity LTPA | Experimental | Behavioral: Physical activityLeisure time physical activity (LTPA): Exercise intensity: 70% of maximal oxygen uptake (VO2 max); Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week |
| Moderate intensity LTPA | Experimental | Behavioral: Physical activityLeisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week |
| Control | No intervention | –Receives no intervention |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participation in main study (NCT 01962259)
Key exclusion criteria (1 listed)
- No participation in main study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity | Behavioural | Moderate intensity LTPA, Vigorous intensity LTPA |
Primary outcome
Total body fat
Time frame: Change from baseline in body fat at 3 months
Changes in total body fat (kg) measured by dual x-ray absorptiometry
Total body fat
Time frame: Change from baseline in body fat at 6 months
Changes in total body fat (kg) measured by dual x-ray absorptiometry
4 secondary outcomes
Net energy balance and degree of compensation
Time frame: 3 and 6 months
Compensatory mechanisms
Time frame: Baseline, 3 and 6 months
Appetite control
Time frame: Baseline, 3 and 6 months
Anthropometry
Time frame: Baseline, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Derived from this study: PubMed 28993707Quist 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bente M Stallknecht, MD PhD DMSc principal investigator
Professor
1 site in 1 country: see every site and its status.
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 1 inclusion and 1 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?
Total body fat (time frame: Change from baseline in body fat at 3 months). The study lists 2 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 NCT01973686, which also lists 1 linked publication.
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.