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Energy Intake and Energy Deficit in Obese Adolescents (IDEFIX)

U

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

Pediatric Obesity

Treatments

Behavioral: DEF-EX : Exercise induced energy deficit
Behavioral: DEF-EI : Energy restriction induced energy deficit

Study type

Interventional

Funder types

Other

Identifiers

NCT03466359
2017-A00817-46 (Other Identifier)
CHU-378

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

12 to 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

DEF-EI
Experimental group
Description:
these adolescents will follow a dietary restriction of 10% of their daily energy intake.
Treatment:
Behavioral: DEF-EI : Energy restriction induced energy deficit
DEF-EX
Experimental group
Description:
these adolescents will increase their physical activity-induced energy expenditure by 10% per day.
Treatment:
Behavioral: DEF-EX : Exercise induced energy deficit

Trial contacts and locations

1

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Central trial contact

Patrick LACARIN

Data sourced from clinicaltrials.gov

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