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Energy Intake and Energy Deficit in Obese Adolescents (IDEFIX)

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ClinicalTrials.gov Identifier: NCT03466359
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Collaborators:
Tza Nou - Maison médicale pour enfants et adolescentes – 230, rue Vercingétorix – B.P. 77 – 63150 La Bourboule
SSR Nutrition-Obésité – 33-35 rue Maréchal Leclerc – 63000 Clermont-Ferrand
University of Clermont-Auvergne
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
The aim of the present study is to compare the effect of two weight loss interventions inducing the same energy deficit but one based on exercise and one using dietary restriction, on appetite control in obese adolescents. Investigator hypothesis that daily energy intake and hunger will be increased in the dietary restriction group but not in response to the exercise program.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Behavioral: DEF-EI : Energy restriction induced energy deficit Behavioral: DEF-EX : Exercise induced energy deficit Not Applicable

Detailed Description:
The present study will compare the nutritional responses to two 4-month weight loss programs inducing the same energy deficit in obese adolescents, one based on exercise and the other one using dietary restriction. After a first 4-month phase stabilizing the adolescents' daily energy intake and expenditure, half of the sample with increase their physical activity to induce a 10% increase of their daily energy expenditure (maintaining the same energy intake) while the other half will stick with the same physical activity program but reduce their daily intake to match for the same 10% energy deficit. Before, at the end and 4 months after the intervention, Investigator will assess the adolescents' energy intake and appetite control by measuring: ad libitum energy intake, appetite feelings throughout the day, food preferences, food reward. But also all the potential underneath mechanisms based on gastro-peptides and adipokines. Finally, sleep metabolism will be assessed using polysomnography as a potential link between weight loss and appetite control. Body composition, quality of life, aerobic capacities and resting metabolic rate will also be measured at each time point.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Nutritional Responses to Chronic Exercise- Versus Energy Restriction-induced Energy Deficits in Obese Adolescents
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DEF-EI
these adolescents will follow a dietary restriction of 10% of their daily energy intake.
Behavioral: DEF-EI : Energy restriction induced energy deficit
DEF-EI : Energy restriction induced energy deficit The content of their energy intake will be decreased by 10% daily compared with the phase one of the protocol (stabilization of intake). This decrease will be allowed by the internship nature of the clinical program; all the meals are prepared and served by the personal of the clinical centre.

Experimental: DEF-EX
these adolescents will increase their physical activity-induced energy expenditure by 10% per day.
Behavioral: DEF-EX : Exercise induced energy deficit
DEF-EX : Exercise induced energy deficit While their intake will remain the same as phase 1, they will increase their physical activity energy expenditure by 10% thanks to an increase of their prescribed exercise intensities or durations.




Primary Outcome Measures :
  1. Changes in energy intake at lunch time [ Time Frame: Before, after 10 months and 4 month after the intervention ]
    food intake will be measured ad libitum during a lunch time buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be assessed by a member of the investigation team


Secondary Outcome Measures :
  1. change in FM [ Time Frame: Before, after 10 months and 4 month after the intervention ]
    Fat mass (FM) was assessed using DXA following standardized procedures

  2. Aerobic capacity [ Time Frame: Before, after 10 months and 4 month after the intervention ]
    VO2peak will be measured during a graded exhaustive cycling test performed by a specialized medical investigator from the Department of Sports Medicine, Functional and Respiratory Rehabilitation (Clermont-Ferrand University Hospital). The initial power will be set at 30 W for three minutes and followed by 15 W increments every 1.5 minutes.

  3. Insulin concentration [ Time Frame: Before, after 10 months and 4 month after the intervention ]
    : Insulin will be assessed thanks to a fasting blood sample taken by a specialized nurse.

  4. Glycaemia concentration [ Time Frame: Before, after 10 months and 4 month after the intervention ]
    glycaemia, will be assessed thanks to a fasting blood sample taken by a specialized nurse.

  5. total cholesterol concentration [ Time Frame: Before, after 10 months and 4 month after the intervention. ]
    cholesterol total will be assessed thanks to a fasting blood sample taken by a specialized nurse.

  6. HDL-C concentration [ Time Frame: Before, after 10 months and 4 month after the intervention ]
    HDL-C will be assessed thanks to a fasting blood sample taken by a specialized nurse

  7. LDL-C concentration [ Time Frame: Before, after 10 months and 4 month after the intervention ]
    LDL-C will be assessed thanks to a fasting blood sample taken by a specialized nurse.

  8. Triglycerides concentration [ Time Frame: Before, after 10 months and 4 month after the intervention ]
    Triglycerides concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse.

  9. Acylated Ghrelin concentration [ Time Frame: Before, after 10 months and 4 month after the intervention ]
    Acylated Ghrelin concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse

  10. Leptin concentration [ Time Frame: Before, after 10 months and 4 month after the intervention ]
    Leptin concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse

  11. Sleep metabolism [ Time Frame: Before, after 10 months and 4 month after the intervention ]
    sleep duration will be assessed during an overnight polysomnography.

  12. appetite feelings [ Time Frame: Before, after 10 months and 4 month after the intervention ]
    hunger satiety will be assessed using visual analogue scale at regular interval through a test day

  13. Quality of life Score [ Time Frame: Before, after 10 months and 4 month after the intervention ]
    A total Quality of life score will be obtain thanks to the "SF36" questionnaire. This is a self-reported questionnaire. A member of the investigation team will be present to help and guide the adolescents if needed

  14. Health Perception [ Time Frame: Before, after 10 months and 4 month after the intervention ]
    A total Health Perception score will be obtain thanks to the "Health Perception Questionnaire ". This is a self-reported questionnaire. A member of the investigation team will be present to help and guide the adolescents if needed.



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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI percentile > 97th percentile according to the french curves.
  • ages 12-16 years old
  • Signed consent form
  • being registered in the national social security system
  • no contraindication to physical activity

Exclusion Criteria:

  • Previous surgical interventions that is considered as non-compatible with the study.
  • Diabetes
  • weight loss during the last 6 months
  • cardiovascular disease or risks

Information from the National Library of Medicine

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): NCT03466359


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Yves BOIRIE         
Sub-Investigator: David THIVEL         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Tza Nou - Maison médicale pour enfants et adolescentes – 230, rue Vercingétorix – B.P. 77 – 63150 La Bourboule
SSR Nutrition-Obésité – 33-35 rue Maréchal Leclerc – 63000 Clermont-Ferrand
University of Clermont-Auvergne
Investigators
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Principal Investigator: Yves BOIRIE University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03466359     History of Changes
Other Study ID Numbers: CHU-378
2017-A00817-46 ( Other Identifier: 2017-A00817-46 )
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
appetite control
obesity
Adolescents
Physical activity
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Butyl phosphorotrithioate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action