Pediatric ObesityNCT02482220
Physical Activity Program and Energy Intake Control in Obese Adolescents
A study testing Physical activity intervention in people with Pediatric Obesity, run by Université Blaise Pascal, Clermont-Ferrand at 1 site in France.
Trial summary
Acute exercise of high intensity has been shown to induced nutritional adaptations in obese adolescents. Indeed, several studies have shown that about 30 minutes of intensive exercise (above 70% of the adolescents maximal aerobic capacities) can favor reduced-energy consumption at the following meal with no… Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Dec 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 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 12 to 15 years old adolescents
- Obese according to international values for BMI
- Being registered to the national social security insurance
- no eating disorders
- no medications
- metabolic disorders
Who cannot join
- metabolic disorders
- food disorders
- physical disability
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
AME2P Laboratory
Clermont-Ferrand, Auvergne, 63000
David Thivel, PhD, 0473407679, thiveldavid@hotmail.com
Lore Metz, PhD, 0473407679, lore.Metz@univ-bpclermont.fr
About this study
Official title: Physical Activity and Energy Intake Control in Obese Adolescents: Effect of Exercise Programs of Various Intensities
Acute exercise of high intensity has been shown to induced nutritional adaptations in obese adolescents. Indeed, several studies have shown that about 30 minutes of intensive exercise (above 70% of the adolescents maximal aerobic capacities) can favor reduced-energy consumption at the following meal with no modification of their appetite feelings. Although it is suggested that chronic physical activity programs can induce energy intake modifications, this has never been clearly studied. The aim of this work is to compare different physical activity programs (low vs. high intensity programs) in terms of energy intake, appetite feelings and appetite-regulating hormones, in obese adolescents.
Read the detailed description
After an first medical visit to ensure that the adolescents have the ability to complete the whole study, the participants will have to complete several clinical examinations:
- anthropometric measurements
- Body composition assessed by DXA
- Maximal aerobic test
- Blood samples (appetite-regulating hormones)
- daily energy intake assessment during a 24h intake exploration.
The adolescents recruited will then be randomly assigned to one of the two intervention groups:
- High Intensity program or moderate intensity program. Those two physical activity programs will last 4-months and will be composed of 3 to 4 exercise sessions per week. The High intensity program will consists in High intensity interval exercises starting at 70% of the adolescents' capacities at the beginning to end around 95%. The moderate intensity program will propose continuous exercises set between 50-65% VO2max.
No energy intake intervention will be performed.
By the end of the 4-months intervention, all the clinical examinations performed before the intervention will be repeated.
- Conditions
- Pediatric Obesity
- Being tested
- Physical activity intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| High intensity | Experimental | in this group, the participants will follow a high intensity physical activity program (High Intensity Interval exercise from 75 to 95% VO2max) Receives: Behavioral: Physical activity intervention |
| Moderate intensity | Experimental | in this group, the participants will follow a moderate intensity physical activity program (Intensity from 50 to 65% VO2max) Receives: Behavioral: Physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Energy intake in kcal is being assessed
daily energy intake will be assessed
Measured: energy intake will be assessed during 24h during the week before the intervention (T0) and the week after (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Blaise Pascal, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, THIVEL David, Université Blaise Pascal, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482220
- Sponsor's protocol ID
- AU 1178
- Status last verified
- May 2016
- First submitted
- 19 Jun 2015
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Energy Intake Control in Obese Adolescents: Effect of Exercise Programs of Various Intensities
- ClinicalTrials.gov ID
- NCT02482220
- Acronym / sponsor ID
- AU 1178
- Conditions
- Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Université Blaise Pascal, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 26 Jun 2015 (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.
Acute exercise of high intensity has been shown to induced nutritional adaptations in obese adolescents. Indeed, several studies have shown that about 30 minutes of intensive exercise (above 70% of the adolescents maximal aerobic capacities) can favor reduced-energy consumption at the following meal with no modification of their appetite feelings. Although it is suggested that chronic physical activity programs can induce energy intake modifications, this has never been clearly studied. The aim of this work is to compare different physical activity programs (low vs. high intensity programs) in terms of energy intake, appetite feelings and appetite-regulating hormones, in obese adolescents.
Detailed description
After an first medical visit to ensure that the adolescents have the ability to complete the whole study, the participants will have to complete several clinical examinations:
- anthropometric measurements
- Body composition assessed by DXA
- Maximal aerobic test
- Blood samples (appetite-regulating hormones)
- daily energy intake assessment during a 24h intake exploration.
The adolescents recruited will then be randomly assigned to one of the two intervention groups:
- High Intensity program or moderate intensity program. Those two physical activity programs will last 4-months and will be composed of 3 to 4 exercise sessions per week. The High intensity program will consists in High intensity interval exercises starting at 70% of the adolescents' capacities at the beginning to end around 95%. The moderate intensity program will propose continuous exercises set between 50-65% VO2max.
No energy intake intervention will be performed.
By the end of the 4-months intervention, all the clinical examinations performed before the intervention will be repeated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity | Experimental | Behavioral: Physical activity interventionin this group, the participants will follow a high intensity physical activity program (High Intensity Interval exercise from 75 to 95% VO2max) |
| Moderate intensity | Experimental | Behavioral: Physical activity interventionin this group, the participants will follow a moderate intensity physical activity program (Intensity from 50 to 65% VO2max) |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 12 to 15 years old adolescents
- Obese according to international values for BMI
- Being registered to the national social security insurance
- no eating disorders
- no medications
Key exclusion criteria (3 listed)
- metabolic disorders
- food disorders
- physical disability
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 intervention | Behavioural | High intensity, Moderate intensity |
Primary outcome
change in Energy intake in kcal is being assessed
Time frame: energy intake will be assessed during 24h during the week before the intervention (T0) and the week after (T1)
daily energy intake will be assessed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 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.
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 intervention in people with Pediatric Obesity, run by Université Blaise Pascal, Clermont-Ferrand at 1 site in France.
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 6 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: status not confirmed, as of the sponsor's last update on 11 May 2016. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Thivel, PhD (0473407679, thiveldavid@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Energy intake in kcal is being assessed (time frame: energy intake will be assessed during 24h during the week before the intervention (T0) and the week after (T1)). 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 11 May 2016.