search
Back to results

Effect of the Exercise-meal Timing on Energy Intake and Appetite in Adolescents With Obesity (TIMEX2)

Primary Purpose

Pediatric obésity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CON
EX-MEAL
MEAL-EX
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric obésity 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 Clermont Ferrand

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cohorte 1

Arm Description

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

Outcomes

Primary Outcome Measures

Change in energy intake measured during an ad libitum buffet meal (in kcal)
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) (Finlayson, King et al. 2008).

Full Information

First Posted
May 27, 2019
Last Updated
June 9, 2020
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
AME2P Laboratory, Clermont Auvergne University
search

1. Study Identification

Unique Protocol Identification Number
NCT03967782
Brief Title
Effect of the Exercise-meal Timing on Energy Intake and Appetite in Adolescents With Obesity
Acronym
TIMEX2
Official Title
Effect of the Exercise-meal Timing on Energy Intake and Appetite in Adolescents With Obesity: the TIMEX 2 Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 31, 2019 (Actual)
Primary Completion Date
September 29, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
AME2P Laboratory, Clermont Auvergne University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the present study is to compare the effect of realizing an exercise right before or right after a meal of 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 right before or right after lunch 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 right before lunch; iii) one session with an acute exercise realized right after 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 obésity
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
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cohorte 1
Arm Type
Experimental
Arm Description
18 adolescents with obesity are involved and will perform the three conditions.
Intervention Type
Behavioral
Intervention Name(s)
CON
Other Intervention Name(s)
control condition without exercise / rest condition
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-MEAL
Other Intervention Name(s)
Condition with an acute exercise set right before lunch
Intervention Description
Condition with an acute exercise set right before lunch The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) right before ad ad libitum lunch meal. 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)
MEAL-EX
Other Intervention Name(s)
Condition with an acute exercise set right after lunch
Intervention Description
. condition with an acute exercise set right after lunch. The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) right after an ad libitul buffet meal. 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 in energy intake measured during an ad libitum buffet meal (in kcal)
Description
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.
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) (Finlayson, King et al. 2008).
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
No
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
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 Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32482455
Citation
Fillon A, Beaulieu K, Miguet M, Bailly M, Finlayson G, Julian V, Masurier J, Mathieu ME, Pereira B, Duclos M, Boirie Y, Thivel D. Does exercising before or after a meal affect energy balance in adolescents with obesity? Nutr Metab Cardiovasc Dis. 2020 Jun 25;30(7):1196-1200. doi: 10.1016/j.numecd.2020.04.015. Epub 2020 Apr 23.
Results Reference
derived

Learn more about this trial

Effect of the Exercise-meal Timing on Energy Intake and Appetite in Adolescents With Obesity

We'll reach out to this number within 24 hrs