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Effect of Exercise Timing on Energy Intake and Appetite in Adolescents With Obesity: the TIMEX 3 Study (TIMEX 3)

Primary Purpose

Pediatric Obesity

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

CON

EX-30

EX-90

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring appetite control, obesity, Adolescents, exercise timing

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Obese adolescents

Arm Description

18 adolescents with obesity are involved and will perform the three conditions.

Outcomes

Primary Outcome Measures

Change of energy intake measured during an ad libitum buffet meal (in kcal).

Change of food intake will be measured ad libitum during a lunch buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be weighted using an electronic food scale by a member of the investigation team and then analysed using Bilnuts software.

Secondary Outcome Measures

Hunger feelings

: hunger area under the curve will be assessed using visual analogue scale through a the day

Food reward

The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ)

Full Information

NCT ID

NCT03968458

First Posted

April 29, 2019

Last Updated

October 4, 2019

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

1. Study Identification

Unique Protocol Identification Number

NCT03968458

Brief Title

Effect of Exercise Timing on Energy Intake and Appetite in Adolescents With Obesity: the TIMEX 3 Study

Acronym

TIMEX 3

Official Title

Effect of Exercise Timing on Energy Intake and Appetite in Adolescents With Obesity: the TIMEX 3 Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 31, 2019 (Actual)

Primary Completion Date

June 30, 2020 (Anticipated)

Study Completion Date

July 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the present study is to compare the effect of the timing (30 vs. 90 minutes) between a fixed exercise and the following test meal on energy intake, appetite feelings and food reward in adolescents with obesity.

Detailed Description

The present study will compare the nutritional response to the realisation of an acute exercise 90 minutes or 30 minutes before an ad libitum buffet meal in adolescents with obesity. 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (rest); ii) one session with an acute exercise realized 90 minutes before lunch; iii) one session with the same exercise performed 30 minutes before lunch. Their ad libitum energy intake will be assessed during lunch as well as at dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pediatric Obesity

Keywords

appetite control, obesity, Adolescents, exercise timing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Obese adolescents

Arm Type

Experimental

Arm Description

18 adolescents with obesity are involved and will perform the three conditions.

Intervention Type

Behavioral

Intervention Name(s)

CON

Intervention Description

. Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.

Intervention Type

Behavioral

Intervention Name(s)

EX-30

Intervention Description

Condition with an acute exercise set 30 minutes before lunch The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.

Intervention Type

Behavioral

Intervention Name(s)

EX-90

Intervention Description

condition with an acute exercise set 90 minutes before lunch. The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.

Primary Outcome Measure Information:

Title

Change of energy intake measured during an ad libitum buffet meal (in kcal).

Description

Time Frame

day 1 , day 8, day 15

Secondary Outcome Measure Information:

Title

Hunger feelings

Description

: hunger area under the curve will be assessed using visual analogue scale through a the day

Time Frame

day 1 , day 8, day 15

Title

Food reward

Description

The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ)

Time Frame

day 1 , day 8, day 15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lise Laclautre

Phone

334.73.754.963

promo_interne_drci@chu-clermontferrand.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

yves Boirie

Organizational Affiliation

University Hospital, Clermont-Ferrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Clermont-Ferrand

City

Clermont-Ferrand

ZIP/Postal Code

63000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lise Laclautre

promo_interne_drci@chu-clermontferrand.fr

First Name & Middle Initial & Last Name & Degree

Yves Boirie

12. IPD Sharing Statement

Learn more about this trial

Effect of Exercise Timing on Energy Intake and Appetite in Adolescents With Obesity: the TIMEX 3 Study

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