Energy Intake and Energy Deficit in Obese Adolescents

NCT ID: NCT03466359

Last Updated: 2018-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2018-12-31

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.

Conditions

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Pediatric Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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DEF-EI

these adolescents will follow a dietary restriction of 10% of their daily energy intake.

Group Type EXPERIMENTAL

DEF-EI : Energy restriction induced energy deficit

Intervention Type BEHAVIORAL

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.

DEF-EX

these adolescents will increase their physical activity-induced energy expenditure by 10% per day.

Group Type EXPERIMENTAL

DEF-EX : Exercise induced energy deficit

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tza Nou - Maison médicale pour enfants et adolescentes - 230, rue Vercingétorix - B.P. 77 - 63150 La Bourboule

UNKNOWN

Sponsor Role collaborator

SSR Nutrition-Obésité - 33-35 rue Maréchal Leclerc - 63000 Clermont-Ferrand

UNKNOWN

Sponsor Role collaborator

Laboratoire AME2P. Campus universitaire des cezeaux, 63170 Aubiere, Cedex

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yves BOIRIE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Facility Contacts

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Patrick LACARIN

Role: primary

04 73 75 11 95

References

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Roche J, Corgosinho FC, Damaso AR, Isacco L, Miguet M, Fillon A, Guyon A, Moreira GA, Pradella-Hallinan M, Tufik S, Tulio de Mello M, Gillet V, Pereira B, Duclos M, Boirie Y, Masurier J, Franco P, Thivel D, Mougin F. Sleep-disordered breathing in adolescents with obesity: When does it start to affect cardiometabolic health? Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):683-693. doi: 10.1016/j.numecd.2019.12.003. Epub 2019 Dec 16.

Reference Type DERIVED
PMID: 32008915 (View on PubMed)

Other Identifiers

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2017-A00817-46

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-378

Identifier Type: -

Identifier Source: org_study_id

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