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Physical Activity and Food Intake Interaction: Effect of Weight Loss in Obese Adolescent

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ClinicalTrials.gov Identifier: NCT02664844
Recruitment Status : Completed
First Posted : January 27, 2016
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Physical activity Not Applicable

Detailed Description:
Two measuring sequences will be carried out before (M0) and after 4 months (M4) of a multidisciplinary treatment program of four months. Each sequence will have three days: a "sedentary" day (SED) and two days "exercise" (EX). During the exercise day "EX1", a continuous intense exercise will be conducted for 40 min at 70% VO2max of subjects. During the second day exercise "EX2" teenage realize two exercise representing the same DE as EX1 in the morning (50% ED) and late afternoon (50% ED). The multidisciplinary management program (without energy restriction) controlled by institution consists of nutrition education, physical activity and therapeutic education. The exercise program will involve the activity sessions controlled and supervised by a sports educator and interactive sessions using a scientifically validated physical activity program (Biomouv®).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Activity and Food Intake Interaction: Effect of Weight Loss in Obese Adolescent
Study Start Date : September 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Obese adolescent Behavioral: Physical activity


Outcome Measures
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Primary Outcome Measures :
  1. Comparison between(M0) and (M4) of food intake on 24 hours (total and per meal) [ Time Frame: after 4 months of physical activity ]
    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.


Secondary Outcome Measures :
  1. Comparison between(M0) and (M4) of the Flint scale [ Time Frame: after 4 months of physical activity ]
    Comparison between(M0) and (M4) of the Flint scale (feeling of hunger, desire to eat, the feeling of being full)

  2. Comparison between(M0) and (M4) of the Pittsburg scale [ Time Frame: after 4 months of physical activity ]
  3. Comparison between(M0) and (M4) of HOMA-IR [ Time Frame: after 4 months of physical activity ]
    Comparison between(M0) and (M4) of HOMA-IR by measuring the blood glucose and fasting insulin

  4. Comparison between(M0) and (M4) of Fitness [ Time Frame: after 4 months of physical activity ]
    Comparison between(M0) and (M4) of Fitness (by VO2 max and estimated body composition).


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664844


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
More Information
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02664844    
Other Study ID Numbers: CHU-0255
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Keywords provided by University Hospital, Clermont-Ferrand:
Obesity
Appetite regulation
Insulin sensitivity
Adolescents
Exercise
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Body Weight Changes