Physical Activity and Food Intake Interaction: Effect of Weight Loss in Obese Adolescent
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Appetite regulation, Insulin sensitivity, Adolescents, Exercise
Eligibility 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
Sites / Locations
- CHU Clermont-Ferrand
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Obese adolescent
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Comparison between(M0) and (M4) of the Flint scale
Comparison between(M0) and (M4) of the Flint scale (feeling of hunger, desire to eat, the feeling of being full)
Comparison between(M0) and (M4) of the Pittsburg scale
Comparison between(M0) and (M4) of HOMA-IR
Comparison between(M0) and (M4) of HOMA-IR by measuring the blood glucose and fasting insulin
Comparison between(M0) and (M4) of Fitness
Comparison between(M0) and (M4) of Fitness (by VO2 max and estimated body composition).
Full Information
NCT ID
NCT02664844
First Posted
January 15, 2016
Last Updated
January 22, 2016
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT02664844
Brief Title
Physical Activity and Food Intake Interaction: Effect of Weight Loss in Obese Adolescent
Official Title
Physical Activity and Food Intake Interaction: Effect of Weight Loss in Obese Adolescent
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. Study Description
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.
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®).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Appetite regulation, Insulin sensitivity, Adolescents, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obese adolescent
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Primary Outcome Measure Information:
Title
Comparison between(M0) and (M4) of food intake on 24 hours (total and per meal)
Description
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.
Time Frame
after 4 months of physical activity
Secondary Outcome Measure Information:
Title
Comparison between(M0) and (M4) of the Flint scale
Description
Comparison between(M0) and (M4) of the Flint scale (feeling of hunger, desire to eat, the feeling of being full)
Time Frame
after 4 months of physical activity
Title
Comparison between(M0) and (M4) of the Pittsburg scale
Time Frame
after 4 months of physical activity
Title
Comparison between(M0) and (M4) of HOMA-IR
Description
Comparison between(M0) and (M4) of HOMA-IR by measuring the blood glucose and fasting insulin
Time Frame
after 4 months of physical activity
Title
Comparison between(M0) and (M4) of Fitness
Description
Comparison between(M0) and (M4) of Fitness (by VO2 max and estimated body composition).
Time Frame
after 4 months of physical activity
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Learn more about this trial
Physical Activity and Food Intake Interaction: Effect of Weight Loss in Obese Adolescent
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