ObesityNCT02143453
Comparative Study of High Intensity Interval Training and Endurance Training in Juvenile Obesity
A study testing Endurance training and High intensity interval training in people with Obesity, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Exercise is an effective strategy to manage juvenile obesity; however this ideal exercise training mode is still unclear. In this study, the investigators compared the health-related effects of high intensity interval training versus endurance training in obese children. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Obesity
- What is being tested?
- Endurance training and High intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Aug 2011
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 8 and 12 years
- Body mass index (BMI) = 95th percentile, according to the First National Health and Nutrition Examination Survey
- no pharmacological treatment
- no evidence of metabolic, hormonal, orthopedic, and cardiovascular disease at the time of the study's commencement
- no participation in any regular exercise training program (except physical education classes, two days a week) at least 6 months before the commencement of the study and throughout the protocol.
Who cannot join
- non-obese participants
- physically active participants
- participants with cardiovascular diseases or any other condition that could preclude the participation in the the exercise training program
Trial locations and contacts
1 site in 1 country.
Brazil1 site
General Hospital (School of Medicine, University of Sao Paulo)
São Paulo, São Paulo
About this study
Exercise is an effective strategy to manage juvenile obesity; however this ideal exercise training mode is still unclear. In this study, the investigators compared the health-related effects of high intensity interval training versus endurance training in obese children.
- Conditions
- Obesity
- Being tested
- Endurance training, High intensity interval training
- Keywords
- exercise, overweight, children
- Medical subject headings
- Obesity, Motor Activity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance trainingOther
30 to 60-minute continuous exercise at 80% of the peak heart rate
High intensity interval trainingOther
3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training | Experimental | Not described Receives: Other: High intensity interval training |
| Endurance training | Experimental | Not described Receives: Other: Endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index (BMI)
Measured: 12 weeks
aerobic conditioning (VO2max)
Measured: 12 weeks
insulin sensitivity (HOMA-index)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startAug 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
- Investigators
- Bruno Gualano, Professor, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143453
- Sponsor's protocol ID
- HIIT in Juvenile Obesity
- Status last verified
- May 2014
- First submitted
- 18 May 2014
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of High Intensity Interval Training and Endurance Training in Juvenile Obesity
- ClinicalTrials.gov ID
- NCT02143453
- Acronym / sponsor ID
- HIIT in Juvenile Obesity
- Conditions
- Obesity
- Keywords
- exercise, overweight, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 May 2014 (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.
Exercise is an effective strategy to manage juvenile obesity; however this ideal exercise training mode is still unclear. In this study, the investigators compared the health-related effects of high intensity interval training versus endurance training in obese children.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training | Experimental | Other: High intensity interval training |
| Endurance training | Experimental | Other: Endurance training |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age between 8 and 12 years
- Body mass index (BMI) = 95th percentile, according to the First National Health and Nutrition Examination Survey
- no pharmacological treatment
- no evidence of metabolic, hormonal, orthopedic, and cardiovascular disease at the time of the study's commencement
- no participation in any regular exercise training program (except physical education classes, two days a week) at least 6 months before the commencement of the study and throughout the protocol.
Key exclusion criteria (3 listed)
- non-obese participants
- physically active participants
- participants with cardiovascular diseases or any other condition that could preclude the participation in the the exercise training program
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 |
|---|---|---|
| Endurance training30 to 60-minute continuous exercise at 80% of the peak heart rate | Other | Endurance training |
| High intensity interval training3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period. | Other | High intensity interval training |
Primary outcome
body mass index (BMI)
Time frame: 12 weeks
aerobic conditioning (VO2max)
Time frame: 12 weeks
insulin sensitivity (HOMA-index)
Time frame: 12 weeks
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 21 May 2014.
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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.
Bruno Gualano, Professor principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance training and High intensity interval training in people with Obesity, run by University of Sao Paulo at 1 site in Brazil.
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 5 inclusion and 3 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 21 May 2014. 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 Brazil. 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?
body mass index (BMI) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2014; AzTrials last refreshed its copy on 2 Nov 2026.