NCT02482220

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

2.5 years

First QC Date

June 19, 2015

Last Update Submit

May 10, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

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

High intensityModerate intensity

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • metabolic disorders
  • food disorders
  • physical disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AME2P Laboratory

Clermont-Ferrand, Auvergne, 63000, France

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, As/Pr, Research scientist

Study Record Dates

First Submitted

June 19, 2015

First Posted

June 26, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations