Energy Intake and Energy Deficit in Obese Adolescents (IDEFIX)
Primary Purpose
Pediatric Obesity
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DEF-EI : Energy restriction induced energy deficit
DEF-EX : Exercise induced energy deficit
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Obesity focused on measuring appetite control, obesity, Adolescents, Physical activity
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-FerrandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
DEF-EI
DEF-EX
Arm Description
these adolescents will follow a dietary restriction of 10% of their daily energy intake.
these adolescents will increase their physical activity-induced energy expenditure by 10% per day.
Outcomes
Primary Outcome Measures
Changes in energy intake at lunch time
food intake will be measured ad libitum during a lunch time buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be assessed by a member of the investigation team
Secondary Outcome Measures
change in FM
Fat mass (FM) was assessed using DXA following standardized procedures
Aerobic capacity
VO2peak will be measured during a graded exhaustive cycling test performed by a specialized medical investigator from the Department of Sports Medicine, Functional and Respiratory Rehabilitation (Clermont-Ferrand University Hospital). The initial power will be set at 30 W for three minutes and followed by 15 W increments every 1.5 minutes.
Insulin concentration
: Insulin will be assessed thanks to a fasting blood sample taken by a specialized nurse.
Glycaemia concentration
glycaemia, will be assessed thanks to a fasting blood sample taken by a specialized nurse.
total cholesterol concentration
cholesterol total will be assessed thanks to a fasting blood sample taken by a specialized nurse.
HDL-C concentration
HDL-C will be assessed thanks to a fasting blood sample taken by a specialized nurse
LDL-C concentration
LDL-C will be assessed thanks to a fasting blood sample taken by a specialized nurse.
Triglycerides concentration
Triglycerides concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse.
Acylated Ghrelin concentration
Acylated Ghrelin concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse
Leptin concentration
Leptin concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse
Sleep metabolism
sleep duration will be assessed during an overnight polysomnography.
appetite feelings
hunger satiety will be assessed using visual analogue scale at regular interval through a test day
Quality of life Score
A total Quality of life score will be obtain thanks to the "SF36" questionnaire. This is a self-reported questionnaire. A member of the investigation team will be present to help and guide the adolescents if needed
Health Perception
A total Health Perception score will be obtain thanks to the "Health Perception Questionnaire ". This is a self-reported questionnaire. A member of the investigation team will be present to help and guide the adolescents if needed.
Full Information
NCT ID
NCT03466359
First Posted
February 8, 2018
Last Updated
March 8, 2018
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, Laboratoire AME2P. Campus universitaire des cezeaux, 63170 Aubiere, Cedex
1. Study Identification
Unique Protocol Identification Number
NCT03466359
Brief Title
Energy Intake and Energy Deficit in Obese Adolescents
Acronym
IDEFIX
Official Title
Nutritional Responses to Chronic Exercise- Versus Energy Restriction-induced Energy Deficits in Obese Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
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, Laboratoire AME2P. Campus universitaire des cezeaux, 63170 Aubiere, Cedex
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 two weight loss interventions inducing the same energy deficit but one based on exercise and one using dietary restriction, on appetite control in obese adolescents. Investigator hypothesis that daily energy intake and hunger will be increased in the dietary restriction group but not in response to the exercise program.
Detailed Description
The present study will compare the nutritional responses to two 4-month weight loss programs inducing the same energy deficit in obese adolescents, one based on exercise and the other one using dietary restriction. After a first 4-month phase stabilizing the adolescents' daily energy intake and expenditure, half of the sample with increase their physical activity to induce a 10% increase of their daily energy expenditure (maintaining the same energy intake) while the other half will stick with the same physical activity program but reduce their daily intake to match for the same 10% energy deficit. Before, at the end and 4 months after the intervention, Investigator will assess the adolescents' energy intake and appetite control by measuring: ad libitum energy intake, appetite feelings throughout the day, food preferences, food reward. But also all the potential underneath mechanisms based on gastro-peptides and adipokines. Finally, sleep metabolism will be assessed using polysomnography as a potential link between weight loss and appetite control. Body composition, quality of life, aerobic capacities and resting metabolic rate will also be measured at each time point.
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, Physical activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DEF-EI
Arm Type
Experimental
Arm Description
these adolescents will follow a dietary restriction of 10% of their daily energy intake.
Arm Title
DEF-EX
Arm Type
Experimental
Arm Description
these adolescents will increase their physical activity-induced energy expenditure by 10% per day.
Intervention Type
Behavioral
Intervention Name(s)
DEF-EI : Energy restriction induced energy deficit
Intervention Description
DEF-EI : Energy restriction induced energy deficit The content of their energy intake will be decreased by 10% daily compared with the phase one of the protocol (stabilization of intake). This decrease will be allowed by the internship nature of the clinical program; all the meals are prepared and served by the personal of the clinical centre.
Intervention Type
Behavioral
Intervention Name(s)
DEF-EX : Exercise induced energy deficit
Intervention Description
DEF-EX : Exercise induced energy deficit While their intake will remain the same as phase 1, they will increase their physical activity energy expenditure by 10% thanks to an increase of their prescribed exercise intensities or durations.
Primary Outcome Measure Information:
Title
Changes in energy intake at lunch time
Description
food intake will be measured ad libitum during a lunch time buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be assessed by a member of the investigation team
Time Frame
Before, after 10 months and 4 month after the intervention
Secondary Outcome Measure Information:
Title
change in FM
Description
Fat mass (FM) was assessed using DXA following standardized procedures
Time Frame
Before, after 10 months and 4 month after the intervention
Title
Aerobic capacity
Description
VO2peak will be measured during a graded exhaustive cycling test performed by a specialized medical investigator from the Department of Sports Medicine, Functional and Respiratory Rehabilitation (Clermont-Ferrand University Hospital). The initial power will be set at 30 W for three minutes and followed by 15 W increments every 1.5 minutes.
Time Frame
Before, after 10 months and 4 month after the intervention
Title
Insulin concentration
Description
: Insulin will be assessed thanks to a fasting blood sample taken by a specialized nurse.
Time Frame
Before, after 10 months and 4 month after the intervention
Title
Glycaemia concentration
Description
glycaemia, will be assessed thanks to a fasting blood sample taken by a specialized nurse.
Time Frame
Before, after 10 months and 4 month after the intervention
Title
total cholesterol concentration
Description
cholesterol total will be assessed thanks to a fasting blood sample taken by a specialized nurse.
Time Frame
Before, after 10 months and 4 month after the intervention.
Title
HDL-C concentration
Description
HDL-C will be assessed thanks to a fasting blood sample taken by a specialized nurse
Time Frame
Before, after 10 months and 4 month after the intervention
Title
LDL-C concentration
Description
LDL-C will be assessed thanks to a fasting blood sample taken by a specialized nurse.
Time Frame
Before, after 10 months and 4 month after the intervention
Title
Triglycerides concentration
Description
Triglycerides concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse.
Time Frame
Before, after 10 months and 4 month after the intervention
Title
Acylated Ghrelin concentration
Description
Acylated Ghrelin concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse
Time Frame
Before, after 10 months and 4 month after the intervention
Title
Leptin concentration
Description
Leptin concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse
Time Frame
Before, after 10 months and 4 month after the intervention
Title
Sleep metabolism
Description
sleep duration will be assessed during an overnight polysomnography.
Time Frame
Before, after 10 months and 4 month after the intervention
Title
appetite feelings
Description
hunger satiety will be assessed using visual analogue scale at regular interval through a test day
Time Frame
Before, after 10 months and 4 month after the intervention
Title
Quality of life Score
Description
A total Quality of life score will be obtain thanks to the "SF36" questionnaire. This is a self-reported questionnaire. A member of the investigation team will be present to help and guide the adolescents if needed
Time Frame
Before, after 10 months and 4 month after the intervention
Title
Health Perception
Description
A total Health Perception score will be obtain thanks to the "Health Perception Questionnaire ". This is a self-reported questionnaire. A member of the investigation team will be present to help and guide the adolescents if needed.
Time Frame
Before, after 10 months and 4 month after the intervention
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@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 Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Yves BOIRIE
First Name & Middle Initial & Last Name & Degree
David THIVEL
12. IPD Sharing Statement
Citations:
PubMed Identifier
32008915
Citation
Roche J, Corgosinho FC, Damaso AR, Isacco L, Miguet M, Fillon A, Guyon A, Moreira GA, Pradella-Hallinan M, Tufik S, Tulio de Mello M, Gillet V, Pereira B, Duclos M, Boirie Y, Masurier J, Franco P, Thivel D, Mougin F. Sleep-disordered breathing in adolescents with obesity: When does it start to affect cardiometabolic health? Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):683-693. doi: 10.1016/j.numecd.2019.12.003. Epub 2019 Dec 16.
Results Reference
derived
Learn more about this trial
Energy Intake and Energy Deficit in Obese Adolescents
We'll reach out to this number within 24 hrs