Physical Activity Program and Energy Intake Control in Obese Adolescents

Pediatric Obesity Clinical Trial

Official title:

Physical Activity and Energy Intake Control in Obese Adolescents: Effect of Exercise Programs of Various Intensities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02482220
• Other study ID #: AU 1178
• Status: Recruiting
• Phase: N/A
• First received: June 19, 2015
• Last updated: May 10, 2016
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2016
• Source: Université Blaise Pascal, Clermont-Ferrand
• Contact: David Thivel, PhD
• Phone: 0473407679
• Email: thiveldavid[@]hotmail.com
• Is FDA regulated: No
• Health authority: France: National Agency for Food Security
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

Behavioral:
• Physical activity intervention

Locations

Country	Name	City	State
France	AME2P Laboratory	Clermont-ferrand	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
Université Blaise Pascal, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Energy intake in kcal is being assessed	daily energy intake will be assessed	energy intake will be assessed during 24h during the week before the intervention (T0) and the week after (T1)	No