NCT03466359

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

February 8, 2018

Last Update Submit

March 8, 2018

Conditions

Pediatric Obesity

Keywords

appetite controlobesityAdolescentsPhysical activity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • change in FM

    Before, after 10 months and 4 month after the intervention

  • Aerobic capacity

    Before, after 10 months and 4 month after the intervention

  • Insulin concentration

    Before, after 10 months and 4 month after the intervention

  • Glycaemia concentration

    Before, after 10 months and 4 month after the intervention

  • total cholesterol concentration

    Before, after 10 months and 4 month after the intervention.

  • +9 more secondary outcomes

Study Arms (2)

DEF-EI

EXPERIMENTAL

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

Behavioral: DEF-EI : Energy restriction induced energy deficit

DEF-EX

EXPERIMENTAL

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

Behavioral: DEF-EX : Exercise induced energy deficit

Interventions

DEF-EI : Energy restriction induced energy deficitBEHAVIORAL

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-EI
DEF-EX : Exercise induced energy deficitBEHAVIORAL

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.

DEF-EX

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32008915DERIVED

MeSH Terms

Conditions

Pediatric ObesityObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Yves BOIRIE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2018

First Posted

March 15, 2018

Study Start

January 8, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 15, 2018

Record last verified: 2018-03

Locations

FR(1)