ObesityNCT00682266
High-intensity Exercise Training or Multidisciplinary Treatment in Extremely Obese Adolescents
A study testing Multidisciplinary approach (MTG) in people with Obesity and Cardiovascular Diseases, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim of the present study was to determine the effects of a multidisciplinary approach and intensity-controlled interval training on cardiovascular risk factors in overweight adolescents Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Obesity, Cardiovascular Diseases
- What is being tested?
- Multidisciplinary approach (MTG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2004to Mar 2008
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI >+ 2SD (age adjusted)
- Fitted for group treatment
- at least one parent attending the treatment
Who cannot join
- Not able to join treatment
- not able to walk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Cardiovascular Risk Factors In Overweight Adolescents: Multidisciplinary Treatment and Intensity Controlled Interval Training
The aim of the present study was to determine the effects of a multidisciplinary approach and intensity-controlled interval training on cardiovascular risk factors in overweight adolescents
- Conditions
- Obesity, Cardiovascular Diseases
- Being tested
- intensity controlled interval training (AIT), Multidisciplinary approach (MTG)
- Keywords
- Adolescent, Overweight, Exercise, multidisciplinary approach, Oxygen uptake, Flow mediated dilatation, Cardiovascular Risk Factors
- Medical subject headings
- Obesity, Cardiovascular Diseases, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensity controlled interval training (AIT)Behavioural
4 x 4 min intervals at 90% of maximal heart rate, each interval separated by 3 min at 70%, twice a week for 3 months
Multidisciplinary approach (MTG)Behavioural
exercise, dietary and psychological advice, twice a month for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Aerobic interval training | Experimental | intensity-controlled interval training Receives: Behavioral: intensity controlled interval training (AIT) |
| MTG | Experimental | multidisciplinary approach Receives: Behavioral: Multidisciplinary approach (MTG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow mediated Diameter Maximal oxygen uptake BMI
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startFeb 2004
- Primary completionOct 2007
- Study completionMar 2008
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 ObesityStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rønnaug Ødegård, Dr.med, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682266
- Sponsor's protocol ID
- 251076
- Status last verified
- Jan 2012
- First submitted
- 20 May 2008
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Tjonna AE, Stolen TO, Bye A, Volden M, Slordahl SA, Odegard R, Skogvoll E, Wisloff U. Aerobic interval training reduces cardiovascular risk factors more than a multitreatment approach in overweight adolescents. Clin Sci (Lond). 2009 Feb;116(4):317-26. doi: 10.1042/CS20080249.
PubMed 18673303
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Cardiovascular Risk Factors In Overweight Adolescents: Multidisciplinary Treatment and Intensity Controlled Interval Training
- ClinicalTrials.gov ID
- NCT00682266
- Acronym / sponsor ID
- 251076
- Conditions
- Obesity, Cardiovascular Diseases
- Keywords
- Adolescent, Overweight, Exercise, multidisciplinary approach, Oxygen uptake, Flow mediated dilatation, Cardiovascular Risk Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 22 May 2008 (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 was to determine the effects of a multidisciplinary approach and intensity-controlled interval training on cardiovascular risk factors in overweight adolescents
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic interval training | Experimental | Behavioral: intensity controlled interval training (AIT)intensity-controlled interval training |
| MTG | Experimental | Behavioral: Multidisciplinary approach (MTG)multidisciplinary approach |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- BMI >+ 2SD (age adjusted)
- Fitted for group treatment
- at least one parent attending the treatment
Key exclusion criteria (2 listed)
- Not able to join treatment
- not able to walk
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 |
|---|---|---|
| intensity controlled interval training (AIT)4 x 4 min intervals at 90% of maximal heart rate, each interval separated by 3 min at 70%, twice a week for 3 months | Behavioural | Aerobic interval training |
| Multidisciplinary approach (MTG)exercise, dietary and psychological advice, twice a month for 12 months | Behavioural | MTG |
Primary outcome
Flow mediated Diameter Maximal oxygen uptake BMI
Time frame: 12 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 6 Jan 2012.
- Results publication: PubMed 18673303Tjonna AE, Stolen TO, Bye A, Volden M, Slordahl SA, Odegard R, Skogvoll E, Wisloff U. Aerobic interval training reduces cardiovascular risk factors more than a multitreatment approach in overweight adolescents. Clin Sci (Lond). 2009 Feb;116(4):317-26. doi: 10.1042/CS20080249.
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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.
Rønnaug Ødegård, Dr.med study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary approach (MTG) in people with Obesity and Cardiovascular Diseases, run by Norwegian University of Science and Technology at 1 site in Norway.
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 3 inclusion and 2 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 6 Jan 2012. 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 Norway. 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?
Flow mediated Diameter Maximal oxygen uptake BMI (time frame: 12 months). 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 NCT00682266, 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 6 Jan 2012.