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Energy Intake and Energy Deficit in Obese Adolescents

Not Applicable
Conditions
Pediatric Obesity
Registration Number
NCT03466359
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
50
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Changes in energy intake at lunch timeBefore, 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
NameTimeMethod
change in FMBefore, after 10 months and 4 month after the intervention

Fat mass (FM) was assessed using DXA following standardized procedures

Leptin concentrationBefore, 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

appetite feelingsBefore, 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

Quality of life ScoreBefore, 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

Health PerceptionBefore, 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.

Glycaemia concentrationBefore, after 10 months and 4 month after the intervention

glycaemia, will be assessed thanks to a fasting blood sample taken by a specialized nurse.

total cholesterol concentrationBefore, 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.

LDL-C concentrationBefore, 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.

Sleep metabolismBefore, after 10 months and 4 month after the intervention

sleep duration will be assessed during an overnight polysomnography.

HDL-C concentrationBefore, 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

Triglycerides concentrationBefore, 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.

Insulin concentrationBefore, after 10 months and 4 month after the intervention

: Insulin will be assessed thanks to a fasting blood sample taken by a specialized nurse.

Acylated Ghrelin concentrationBefore, 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

Aerobic capacityBefore, 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.

Trial Locations

Locations (1)

CHU Clermont-Ferrand

🇫🇷

Clermont-Ferrand, France

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