Energy Intake, Exercise and Energy Replacement
Primary Purpose
Pediatric Obesity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CON . control condition without exercise / rest condition
EX. Condition with an acute exercise set in the middle of the morning
EX+R. condition with an acute exercise set in the morning and followed by a energy replacement snack
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Obesity focused on measuring appetite control, obesity, Adolescents, exercise, Energy replacement
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
Sites / Locations
- Chu Clermont-Ferrand
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
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
Measurement of hunger feelings
hunger area under the curve will be assessed using visual analogue scale through a the day (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
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).Briefly, the LFPQ provides measures of the wanting and liking for an array of food images, varying in both fat content and taste
Full Information
NCT ID
NCT03742622
First Posted
November 6, 2018
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
1. Study Identification
Unique Protocol Identification Number
NCT03742622
Brief Title
Energy Intake, Exercise and Energy Replacement
Official Title
Does Energy Replacement 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
November 17, 2018 (Actual)
Primary Completion Date
March 3, 2019 (Actual)
Study Completion Date
March 3, 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 alone versus. An exercise followed by the ingestion of an energy replacement snack on the following energy intake, food reward and appetite feelings in adolescents with obesity.
Detailed Description
The present study will compare the nutritional response to the realisation of an acute exercise with and without an energy replacement snack on the following energy intake 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 during the morning; iii) one session with the same exercise followed by a snack covering the exercise-induced energy expenditure. Their ad libitum energy intake will be assessed at the following meal 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, Energy replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
no masking
Allocation
N/A
Enrollment
14 (Actual)
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 . control condition without exercise / rest condition
Intervention Description
CON . 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. Condition with an acute exercise set in the middle of the morning
Intervention Description
EX. Condition with an acute exercise set in the middle of the morning The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) in 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+R. condition with an acute exercise set in the morning and followed by a energy replacement snack
Intervention Description
EX+R. condition with an acute exercise set in the morning and followed by a energy replacement snack The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) in the morning followed by a snack that will cover the whole exercise-induced energy expenditure. They will then 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.
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 by a member of the investigation team and then analysed using Bilnuts software
Time Frame
at lunch (at day 1)
Secondary Outcome Measure Information:
Title
Measurement of hunger feelings
Description
hunger area under the curve will be assessed using visual analogue scale through a the day (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
Time Frame
at day 1
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).Briefly, the LFPQ provides measures of the wanting and liking for an array of food images, varying in both fat content and taste
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
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
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Energy Intake, Exercise and Energy Replacement
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