Energy Intake and Energy Deficit in Obese Adolescents

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Nutritional Responses to Chronic Exercise- Versus Energy Restriction-induced Energy Deficits in Obese Adolescents

Conditions
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Pediatric Obesity

Intervention / Treatment
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* Behavioral: DEF-EI : Energy restriction induced energy deficit
* Behavioral: DEF-EX : Exercise induced energy deficit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEF-EI<br>these adolescents will follow a dietary restriction of 10% of their daily energy intake. | Behavioral: DEF-EI : Energy restriction induced energy deficit<br>* 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.<br>|
| Experimental: DEF-EX<br>these adolescents will increase their physical activity-induced energy expenditure by 10% per day. | Behavioral: DEF-EX : Exercise induced energy deficit<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in energy intake at lunch time | 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 | Before, after 10 months and 4 month after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in FM | Fat mass (FM) was assessed using DXA following standardized procedures | Before, after 10 months and 4 month after the intervention | 
| Aerobic capacity | 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. | Before, after 10 months and 4 month after the intervention | 
| Insulin concentration | : Insulin will be assessed thanks to a fasting blood sample taken by a specialized nurse. | Before, after 10 months and 4 month after the intervention | 
| Glycaemia concentration | glycaemia, will be assessed thanks to a fasting blood sample taken by a specialized nurse. | Before, after 10 months and 4 month after the intervention | 
| total cholesterol concentration | cholesterol total will be assessed thanks to a fasting blood sample taken by a specialized nurse. | Before, after 10 months and 4 month after the intervention. | 
| HDL-C concentration | HDL-C will be assessed thanks to a fasting blood sample taken by a specialized nurse | Before, after 10 months and 4 month after the intervention | 
| LDL-C concentration | LDL-C will be assessed thanks to a fasting blood sample taken by a specialized nurse. | Before, after 10 months and 4 month after the intervention | 
| Triglycerides concentration | Triglycerides concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse. | Before, after 10 months and 4 month after the intervention | 
| Acylated Ghrelin concentration | Acylated Ghrelin concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse | Before, after 10 months and 4 month after the intervention | 
| Leptin concentration | Leptin concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse | Before, after 10 months and 4 month after the intervention | 
| Sleep metabolism | sleep duration will be assessed during an overnight polysomnography. | Before, after 10 months and 4 month after the intervention | 
| appetite feelings | hunger satiety will be assessed using visual analogue scale at regular interval through a test day | Before, after 10 months and 4 month after the intervention | 
| Quality of life Score | 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 | Before, after 10 months and 4 month after the intervention | 
| Health Perception | 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. | Before, after 10 months and 4 month after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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appetite control, obesity, Adolescents, Physical activity