- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03466359
Energy Intake and Energy Deficit in Obese Adolescents (IDEFIX)
March 8, 2018 updated by: University Hospital, Clermont-Ferrand
Nutritional Responses to Chronic Exercise- Versus Energy Restriction-induced Energy Deficits in Obese Adolescents
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- Recruiting
- Chu Clermont-Ferrand
-
Sub-Investigator:
- David THIVEL
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 16 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: DEF-EI
these adolescents will follow a dietary restriction of 10% of their daily energy intake.
|
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.
|
EXPERIMENTAL: DEF-EX
these adolescents will increase their physical activity-induced energy expenditure by 10% per day.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in energy intake at lunch time
Time Frame: Before, after 10 months and 4 month after the intervention
|
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
|
Before, after 10 months and 4 month after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in FM
Time Frame: Before, after 10 months and 4 month after the intervention
|
Fat mass (FM) was assessed using DXA following standardized procedures
|
Before, after 10 months and 4 month after the intervention
|
Aerobic capacity
Time Frame: Before, after 10 months and 4 month after the intervention
|
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.
|
Before, after 10 months and 4 month after the intervention
|
Insulin concentration
Time Frame: Before, after 10 months and 4 month after the intervention
|
: Insulin will be assessed thanks to a fasting blood sample taken by a specialized nurse.
|
Before, after 10 months and 4 month after the intervention
|
Glycaemia concentration
Time Frame: Before, after 10 months and 4 month after the intervention
|
glycaemia, will be assessed thanks to a fasting blood sample taken by a specialized nurse.
|
Before, after 10 months and 4 month after the intervention
|
total cholesterol concentration
Time Frame: Before, after 10 months and 4 month after the intervention.
|
cholesterol total will be assessed thanks to a fasting blood sample taken by a specialized nurse.
|
Before, after 10 months and 4 month after the intervention.
|
HDL-C concentration
Time Frame: Before, after 10 months and 4 month after the intervention
|
HDL-C will be assessed thanks to a fasting blood sample taken by a specialized nurse
|
Before, after 10 months and 4 month after the intervention
|
LDL-C concentration
Time Frame: Before, after 10 months and 4 month after the intervention
|
LDL-C will be assessed thanks to a fasting blood sample taken by a specialized nurse.
|
Before, after 10 months and 4 month after the intervention
|
Triglycerides concentration
Time Frame: Before, after 10 months and 4 month after the intervention
|
Triglycerides concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse.
|
Before, after 10 months and 4 month after the intervention
|
Acylated Ghrelin concentration
Time Frame: Before, after 10 months and 4 month after the intervention
|
Acylated Ghrelin concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse
|
Before, after 10 months and 4 month after the intervention
|
Leptin concentration
Time Frame: Before, after 10 months and 4 month after the intervention
|
Leptin concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse
|
Before, after 10 months and 4 month after the intervention
|
Sleep metabolism
Time Frame: Before, after 10 months and 4 month after the intervention
|
sleep duration will be assessed during an overnight polysomnography.
|
Before, after 10 months and 4 month after the intervention
|
appetite feelings
Time Frame: Before, after 10 months and 4 month after the intervention
|
hunger satiety will be assessed using visual analogue scale at regular interval through a test day
|
Before, after 10 months and 4 month after the intervention
|
Quality of life Score
Time Frame: Before, after 10 months and 4 month after the intervention
|
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
|
Before, after 10 months and 4 month after the intervention
|
Health Perception
Time Frame: Before, after 10 months and 4 month after the intervention
|
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.
|
Before, after 10 months and 4 month after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 8, 2018
Primary Completion (ANTICIPATED)
December 1, 2018
Study Completion (ANTICIPATED)
December 1, 2018
Study Registration Dates
First Submitted
February 8, 2018
First Submitted That Met QC Criteria
March 8, 2018
First Posted (ACTUAL)
March 15, 2018
Study Record Updates
Last Update Posted (ACTUAL)
March 15, 2018
Last Update Submitted That Met QC Criteria
March 8, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-378
- 2017-A00817-46 (OTHER: 2017-A00817-46)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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