An interventional study of DEF-EI : Energy restriction induced energy deficit and DEF-EX : Exercise induced energy deficit in Pediatric Obesity, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 12 Years to 16 Years. Per ClinicalTrials.gov, last updated 2018-03-15.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Treatment
Among 10 studies in Pediatric Obesity by University Hospital, Clermont-Ferrand — none open to participants now, none under way, none of them phase 3. Pediatric Obesity · University Hospital, Clermont-Ferrand.
Among the 10 studies in Pediatric Obesity by University Hospital, Clermont-Ferrand, this one has the largest planned enrollment, is one of 2 that started in 2018, is one of 10 with no phase, and was the 2nd registered.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
Browse Pediatric Obesity studies →None of the 10 studies in Pediatric Obesity by University Hospital, Clermont-Ferrand is open now.
Of the 124 Pediatric Obesity studies recruiting now, 19 (15%) set no upper age limit and 103 (83%) stop at 75 or younger; 114 take children under 18; 69 take healthy volunteers.
This study: 12 Years to 16 Years · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 2 started in 2018.
This study's planned enrollment of 50 is below the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Median enrollment 21 across the 10 interventional studies. Of the 8 that completed or were terminated, 0 (0%) have results posted.
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University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Pediatric Obesity by University Hospital, Clermont-Ferrand, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
these adolescents will follow a dietary restriction of 10% of their daily energy intake.
Behavioral: DEF-EI : Energy restriction induced energy deficit
these adolescents will increase their physical activity-induced energy expenditure by 10% per day.
Behavioral: DEF-EX : Exercise induced energy deficit
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.
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.
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
Time frame: Before, after 10 months and 4 month after the intervention
change in FM
Fat mass (FM) was assessed using DXA following standardized procedures
Time frame: Before, after 10 months and 4 month after the intervention
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.
Time frame: Before, after 10 months and 4 month after the intervention
Insulin concentration
: 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
Glycaemia concentration
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
total cholesterol concentration
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.
HDL-C concentration
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
LDL-C concentration
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
Triglycerides concentration
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
Acylated Ghrelin concentration
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
Leptin concentration
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
Sleep metabolism
sleep duration will be assessed during an overnight polysomnography.
Time frame: Before, after 10 months and 4 month after the intervention
appetite feelings
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
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
Time frame: Before, after 10 months and 4 month after the intervention
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.
Time frame: Before, after 10 months and 4 month after the intervention
Started Jan 2018 (actual). Primary completion is estimated for Dec 2018, 11 months after the start.
Of 539 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 11 months is below that.
Counting every sponsor, half of 541 studies reached it within 25 months; a quarter within 11 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand →