Physical Activity Program and Energy Intake Control in Ob... | NCT02482220

Studies
Physical Activity Program and Energy Intake Control in Obese Adolescents

NCT02482220

Sponsor

Université Blaise Pascal, Clermont-Ferrand

Status

Unknown status

Last Update Posted

May 11, 2016Estimated

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Pediatric Obesity

Interventions

Physical activity intervention

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Jun 19, 2015

First Submission Date that Met QC Criteria

Jun 25, 2015

First Posted Date

Jun 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2016

Last Update Posted Date

May 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

THIVEL David, PhD, As/Pr, Research scientist, Université Blaise Pascal, Clermont-FerrandPrincipal Investigator

Lead Sponsor

Université Blaise Pascal, Clermont-FerrandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)	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)	Behavioral: Physical activity intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical activity intervention	Behavioral		High intensity Moderate intensity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David Thivel, PhD	Contact	0473407679		thiveldavid@hotmail.com
Lore Metz, PhD	Contact	0473407679		Lore.Metz@univ-bpclermont.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AME2P Laboratory	Recruiting	Clermont-Ferrand	Auvergne	63000	France

Condition Browse Module

MeSH Terms

ID	Term
D063766	Pediatric Obesity

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided