Physical Activity Program and Energy Intake Control in Obese Adolescents
Primary Purpose
Pediatric Obesity
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity intervention
Sponsored by
About this trial
This is an interventional health services research trial for Pediatric Obesity
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- metabolic disorders
- food disorders
- physical disability
Sites / Locations
- AME2P LaboratoryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High intensity
Moderate intensity
Arm Description
in this group, the participants will follow a high intensity physical activity program (High Intensity Interval exercise from 75 to 95% VO2max)
in this group, the participants will follow a moderate intensity physical activity program (Intensity from 50 to 65% VO2max)
Outcomes
Primary Outcome Measures
change in Energy intake in kcal is being assessed
daily energy intake will be assessed
Secondary Outcome Measures
Full Information
NCT ID
NCT02482220
First Posted
June 19, 2015
Last Updated
May 10, 2016
Sponsor
Université Blaise Pascal, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT02482220
Brief Title
Physical Activity Program and Energy Intake Control in Obese Adolescents
Official Title
Physical Activity and Energy Intake Control in Obese Adolescents: Effect of Exercise Programs of Various Intensities
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Blaise Pascal, Clermont-Ferrand
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High intensity
Arm Type
Experimental
Arm Description
in this group, the participants will follow a high intensity physical activity program (High Intensity Interval exercise from 75 to 95% VO2max)
Arm Title
Moderate intensity
Arm Type
Experimental
Arm Description
in this group, the participants will follow a moderate intensity physical activity program (Intensity from 50 to 65% VO2max)
Intervention Type
Behavioral
Intervention Name(s)
Physical activity intervention
Primary Outcome Measure Information:
Title
change in Energy intake in kcal is being assessed
Description
daily energy intake will be assessed
Time Frame
energy intake will be assessed during 24h during the week before the intervention (T0) and the week after (T1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
metabolic disorders
food disorders
physical disability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Thivel, PhD
Phone
0473407679
Email
thiveldavid@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lore Metz, PhD
Phone
0473407679
Email
Lore.Metz@univ-bpclermont.fr
Facility Information:
Facility Name
AME2P Laboratory
City
Clermont-ferrand
State/Province
Auvergne
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Thivel, PhD
Phone
0473407679
Email
thiveldavid@hotmail.com
First Name & Middle Initial & Last Name & Degree
Lore Metz, PhD
Phone
0473407679
Email
lore.Metz@univ-bpclermont.fr
12. IPD Sharing Statement
Learn more about this trial
Physical Activity Program and Energy Intake Control in Obese Adolescents
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