Appetite Response to Exercise- Versus Mixed (Exercise + Dietary Restriction)-Induced Energy Deficit in Adolescents With Obesity (IDEX2)
Primary Purpose
Pediatric Obesity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CON . control condition without exercise / rest condition
Def-Mixed. Condition with a mixed energy deficit induced by exercise + dietary restriction.
Def-EI. Condition with an energy-restriction energy deficit
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Obesity focused on measuring appetite control, obesity, Adolescents, exercise, Energy Deficit
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
20 adolescents with obesity are involved and will perform the three conditions.
Outcomes
Primary Outcome Measures
Change from different intervention of energy intake measured during an ad libitum buffet meal (in kcal).
food intake will be measured ad libitum during a dinner 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
NCT ID
NCT04734639
First Posted
January 27, 2021
Last Updated
September 30, 2021
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Tza Nou - Maison médicale pour enfants et adolescentes, Laboratoire AME2P
1. Study Identification
Unique Protocol Identification Number
NCT04734639
Brief Title
Appetite Response to Exercise- Versus Mixed (Exercise + Dietary Restriction)-Induced Energy Deficit in Adolescents With Obesity
Acronym
IDEX2
Official Title
Appetite Response to Exercise- Versus Mixed (Exercise + Dietary Restriction)-Induced Energy Deficit in Adolescents With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 24, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (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, Laboratoire AME2P
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 iso-energetic energy deficits induced by energy restriction alone or exercise + dietary restriction (Mixed deficit) on energy intake and appetite feelings in adolescents with obesity.
Detailed Description
The present study will compare the nutritional response to an energy deficit of 500 kcal induced once by dietary restriction alone and once by a mixed deficit (50% by exercise and 50% by dietary restriction) (compared with a control condition). 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (CON); ii) one session with a dietary-induced energy deficit (Def-EI); iii) one session with a mixed deficit (50% by exercise and 50% by dietary restriction) (Def-Mixed).
Their ad libitum energy intake will be assessed 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 Deficit
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
Obese adolescents
Arm Type
Experimental
Arm Description
20 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
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 dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
Intervention Type
Behavioral
Intervention Name(s)
Def-Mixed. Condition with a mixed energy deficit induced by exercise + dietary restriction.
Intervention Description
Def-Mixed. Condition with an exercise-induced energy deficit The adolescents will received a calibrated lundh meal with a deduction of 250 kcal compared with the lunch meal of Con; and will be asked to realise an acute exercise set at 65% of their capacities (cycling) during the afternoon, inducing an energy expenditure of 250 kcal. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
Intervention Type
Behavioral
Intervention Name(s)
Def-EI. Condition with an energy-restriction energy deficit
Intervention Description
Condition with an energy-restriction energy deficit The adolescents will receive a calibrated breakfast reduced from 500 kcal compare to their CON and Def-mixed conditions. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
Primary Outcome Measure Information:
Title
Change from different intervention of energy intake measured during an ad libitum buffet meal (in kcal).
Description
food intake will be measured ad libitum during a dinner 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
17 Years
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie JULIAN
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
Learn more about this trial
Appetite Response to Exercise- Versus Mixed (Exercise + Dietary Restriction)-Induced Energy Deficit in Adolescents With Obesity
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