NCT02664844

Brief Summary

In obese adolescents, energy expenditure (EE) of chronic high intensity muscular exercise (\> 70% VO2max) conducted one hour before a meal causes an anorectic effect at lunch and dinner the same day. The effect on food intake of the distribution of this exercise into two sessions during 24h remains to be determined. In addition, a multidisciplinary load of obesity generates a loss of body weight in the short term, which we do not know the effects on energy balance. To our knowledge, the impact of weight loss on the anorectic effect of muscle exercise is unknown.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

January 15, 2016

Last Update Submit

January 22, 2016

Conditions

Keywords

ObesityAppetite regulationInsulin sensitivityAdolescentsExercise

Outcome Measures

Primary Outcomes (1)

  • Comparison between(M0) and (M4) of food intake on 24 hours (total and per meal)

    Comparison between(M0) and (M4) of food intake on 24 hours (total and per meal) assessed during a day with the completion of intense exercise performed in one session EX1, in two sessions (EX2) or sedentary (without exercise: SED). The exercise-induced energy expenditure by 40 minutes at 70% of VO2 max is the same in EX1 and EX2.

    after 4 months of physical activity

Secondary Outcomes (4)

  • Comparison between(M0) and (M4) of the Flint scale

    after 4 months of physical activity

  • Comparison between(M0) and (M4) of the Pittsburg scale

    after 4 months of physical activity

  • Comparison between(M0) and (M4) of HOMA-IR

    after 4 months of physical activity

  • Comparison between(M0) and (M4) of Fitness

    after 4 months of physical activity

Study Arms (1)

Obese adolescent

EXPERIMENTAL
Behavioral: Physical activity

Interventions

Obese adolescent

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Overweight adolescents (over the 90 th percentile of the international cut-off point)
  • Sedentary (according to the IPAQ-A questionnaire)
  • Without eating disorders (according to the DEBQ questionnaire)

You may not qualify if:

  • Medical or surgical antecedents that are incompatible with the study: cardiovascular, endocrine or digestive disease.
  • Drugs that could interfere with the results of the study
  • Surgical intervention in the 3 months
  • Regular consumption of tobacco or Alcohol
  • patients on a diet with caloric restriction
  • Refusal to sign the consent form
  • Regular practice of sport and intensive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

ObesityInsulin ResistanceMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 27, 2016

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations