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Energy Intake and Exercise Timing

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CON . control condition without exercise / rest condition
EX -30. Condition with an acute exercise set 30 minutes before lunch
EX-180. condition with an acute exercise set 180 minutes before lunch
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other 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 Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CON .

EX -30.

EX-180

Arm Description

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.

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.

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 appetite feelings will be assessed at regular intervals.

Outcomes

Primary Outcome Measures

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 (Casio Scale, units: grams) 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 (VAS) through a the day ranging from 0 to 150, 0 being "not at all", 150 being "completely". The question asked being: How hungry are you right now?"
Food reward
Leeds Food Preference Questionnaire; LFPQ.Briefly, the LFPQ provides measures of the wanting and liking for an array of food images, varying in both fat content and taste.To measure the explicit liking and explicit wanting, participants are asked to rate the extent to which they "liked" or "wanted" each randomly presented food item with a 100-mm visual analogue scale. . The construct from the scales are : Explicit liking; Explicit Wanting; Implicit liking, implicit wanting, Fat Choice and Fat Taste. Each component ranged from -50 to +50. There is no total score.

Full Information

First Posted
January 15, 2019
Last Updated
September 11, 2019
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Tza Nou - Maison médicale pour enfants et adolescentes - 230, rue Vercingétorix - B.P. 77 - 63150 La Bourboule, SSR Nutrition-Obésité - 33-35 rue Maréchal Leclerc - 63000 Clermont-Ferrand, Université d'Auvergne
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1. Study Identification

Unique Protocol Identification Number
NCT03807609
Brief Title
Energy Intake and Exercise Timing
Official Title
Does Exercise Timing Modify Post-exercise Energy Intake in Adolescents With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 19, 2019 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Tza Nou - Maison médicale pour enfants et adolescentes - 230, rue Vercingétorix - B.P. 77 - 63150 La Bourboule, SSR Nutrition-Obésité - 33-35 rue Maréchal Leclerc - 63000 Clermont-Ferrand, Université d'Auvergne

4. Oversight

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

5. Study Description

Brief Summary
The aim of the present study is to compare the effect of an exercise performed 180 or 30 minutes before lunch on the energy intake of adolescents with obesity.
Detailed Description
The present study will compare the nutritional response to the realisation of an acute exercise 180 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 180 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
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Masking Description
No masking
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CON .
Arm Type
Experimental
Arm Description
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.
Arm Title
EX -30.
Arm Type
Experimental
Arm Description
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.
Arm Title
EX-180
Arm Type
Experimental
Arm Description
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 appetite feelings will be assessed at regular intervals.
Intervention Type
Other
Intervention Name(s)
CON . 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
Other
Intervention Name(s)
EX -30. Condition with an acute exercise set 30 minutes before lunch
Intervention Description
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
Other
Intervention Name(s)
EX-180. condition with an acute exercise set 180 minutes before lunch
Intervention Description
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
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 (Casio Scale, units: grams) by a member of the investigation team and then analysed using Bilnuts software.
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Hunger feelings
Description
hunger area under the curve will be assessed using visual analogue scale (VAS) through a the day ranging from 0 to 150, 0 being "not at all", 150 being "completely". The question asked being: How hungry are you right now?"
Time Frame
at day 1
Title
Food reward
Description
Leeds Food Preference Questionnaire; LFPQ.Briefly, the LFPQ provides measures of the wanting and liking for an array of food images, varying in both fat content and taste.To measure the explicit liking and explicit wanting, participants are asked to rate the extent to which they "liked" or "wanted" each randomly presented food item with a 100-mm visual analogue scale. . The construct from the scales are : Explicit liking; Explicit Wanting; Implicit liking, implicit wanting, Fat Choice and Fat Taste. Each component ranged from -50 to +50. There is no total score.
Time Frame
at day 1

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
Martine DUCLOS
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
31678149
Citation
Fillon A, Mathieu ME, Masurier J, Roche J, Miguet M, Khammassi M, Finlayson G, Beaulieu K, Pereira B, Duclos M, Boirie Y, Thivel D. Effect of exercise-meal timing on energy intake, appetite and food reward in adolescents with obesity: The TIMEX study. Appetite. 2020 Mar 1;146:104506. doi: 10.1016/j.appet.2019.104506. Epub 2019 Oct 31.
Results Reference
derived

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Energy Intake and Exercise Timing

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