ObesityPAPPAS2NCT02272088
Effect of Different Intensities of Exercise on Daily Energy Expenditure With Physical Activity in Overweight Boys
A study testing physical activity-moderate and Intense physical activity in people with Obesity, run by Rio de Janeiro State University.
Trial summary
The main purpose of this study is evaluate the effect of different intensities of exercise (moderate vs. intense) on the daily energy expenditure in overweight adolescents. Read more about this study
- Who is it for?
- Ages 11 to 14 years, men only
- Conditions the study is for
- Obesity
- What is being tested?
- physical activity-moderate and Intense physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Dec 2014
- 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 11 to 14 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- overweight 6th and 7th grades students consent form signed by parents / tutors
Who cannot join
- diabetes mellitus hypertension or reported cardiovascular disease
About this study
The main purpose of this study is evaluate the effect of different intensities of exercise (moderate vs. intense) on the daily energy expenditure in overweight adolescents.
Read the detailed description
The specific objectives are:
- Assess and quantify the existence of compensatory effect of exercise on subsequent physical activity.
- Compare the amount of daily physical activity in adolescents subjected to different protocols of training intensity.
- Conditions
- Obesity
- Being tested
- physical activity-moderate, Intense physical activity
- Keywords
- physical activity, energy expenditure, compensatory mechanisms, adolescent
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity-moderateBehavioural
cross -over of moderate and intense physical activity
Intense physical activityBehavioural
cross -over of moderate and intense physical activity
| Study group | Role | What they receive |
|---|---|---|
| physical activity-moderate | Experimental | participants will be walking during 60 minutes in a moderate pace Receives: Behavioral: physical activity-moderate; Behavioral: Intense physical activity |
| intense physical activity | Experimental | participants will be running during 60 minutes in na intense pace. Receives: Behavioral: physical activity-moderate; Behavioral: Intense physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy expenditure
measured by triaxial accelerometry
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosely Sichieri, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272088
- Sponsor's protocol ID
- IMS-NEBIN
- Acronym
- PAPPAS2
- Status last verified
- Sep 2019
- First submitted
- 20 Oct 2014
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paravidino VB, Mediano MFF, Sichieri R. Does a single bout of exercise influence subsequent physical activity and sedentary time in overweight boys? Physiol Behav. 2017 May 1;173:231-235. doi: 10.1016/j.physbeh.2017.02.016. Epub 2017 Feb 20.
PubMed 28223036Paravidino VB, Mediano MF, Hoffman DJ, Sichieri R. Effect of Exercise Intensity on Spontaneous Physical Activity Energy Expenditure in Overweight Boys: A Crossover Study. PLoS One. 2016 Jan 15;11(1):e0147141. doi: 10.1371/journal.pone.0147141. eCollection 2016.
PubMed 26771742
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Intensities of Exercise on Daily Energy Expenditure With Physical Activity in Overweight Boys
- ClinicalTrials.gov ID
- NCT02272088
- Acronym / sponsor ID
- PAPPAS2 / IMS-NEBIN
- Conditions
- Obesity
- Keywords
- physical activity, energy expenditure, compensatory mechanisms, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Oct 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.
The main purpose of this study is evaluate the effect of different intensities of exercise (moderate vs. intense) on the daily energy expenditure in overweight adolescents.
Detailed description
The specific objectives are:
- Assess and quantify the existence of compensatory effect of exercise on subsequent physical activity.
- Compare the amount of daily physical activity in adolescents subjected to different protocols of training intensity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical activity-moderate | Experimental | Behavioral: physical activity-moderate, Behavioral: Intense physical activityparticipants will be walking during 60 minutes in a moderate pace |
| intense physical activity | Experimental | Behavioral: physical activity-moderate, Behavioral: Intense physical activityparticipants will be running during 60 minutes in na intense pace. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- overweight 6th and 7th grades students consent form signed by parents / tutors
Key exclusion criteria (1 listed)
- diabetes mellitus hypertension or reported cardiovascular disease
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-moderatecross -over of moderate and intense physical activity | Behavioural | intense physical activity, physical activity-moderate |
| Intense physical activitycross -over of moderate and intense physical activity | Behavioural | intense physical activity, physical activity-moderate |
Primary outcome
energy expenditure
Time frame: one week
measured by triaxial accelerometry
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 17 Sep 2019.
- Derived from this study: PubMed 28223036Paravidino VB, Mediano MFF, Sichieri R. Does a single bout of exercise influence subsequent physical activity and sedentary time in overweight boys? Physiol Behav. 2017 May 1;173:231-235. doi: 10.1016/j.physbeh.2017.02.016. Epub 2017 Feb 20.
- Derived from this study: PubMed 26771742Paravidino VB, Mediano MF, Hoffman DJ, Sichieri R. Effect of Exercise Intensity on Spontaneous Physical Activity Energy Expenditure in Overweight Boys: A Crossover Study. PLoS One. 2016 Jan 15;11(1):e0147141. doi: 10.1371/journal.pone.0147141. eCollection 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity-moderate and Intense physical activity in people with Obesity, run by Rio de Janeiro State University.
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 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
energy expenditure (time frame: one week). 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 NCT02272088, which also lists 2 linked publications.
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 17 Sep 2019.