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Energy Intake and Energy Deficit in Obese Adolescents

Nutritional Responses to Chronic Exercise- Versus Energy Restriction-induced Energy Deficits in Obese Adolescents

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03466359
Acronym
IDEFIX
Enrollment
50
Registered
2018-03-15
Start date
2018-01-08
Completion date
2018-12-31
Last updated
2018-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obesity

Keywords

appetite control, obesity, Adolescents, Physical activity

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.

Interventions

BEHAVIORALDEF-EX : Exercise induced energy deficit

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.

BEHAVIORALDEF-EI : Energy restriction 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.

Sponsors

Tza Nou - Maison médicale pour enfants et adolescentes - 230, rue Vercingétorix - B.P. 77 - 63150 La Bourboule
CollaboratorUNKNOWN
SSR Nutrition-Obésité - 33-35 rue Maréchal Leclerc - 63000 Clermont-Ferrand
CollaboratorUNKNOWN
Laboratoire AME2P. Campus universitaire des cezeaux, 63170 Aubiere, Cedex
CollaboratorUNKNOWN
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in energy intake at lunch timeBefore, after 10 months and 4 month after the interventionfood 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

MeasureTime frameDescription
Aerobic capacityBefore, after 10 months and 4 month after the interventionVO2peak 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 concentrationBefore, after 10 months and 4 month after the intervention: Insulin will be assessed thanks to a fasting blood sample taken by a specialized nurse.
Glycaemia concentrationBefore, after 10 months and 4 month after the interventionglycaemia, will be assessed thanks to a fasting blood sample taken by a specialized nurse.
total cholesterol concentrationBefore, 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.
HDL-C concentrationBefore, after 10 months and 4 month after the interventionHDL-C will be assessed thanks to a fasting blood sample taken by a specialized nurse
LDL-C concentrationBefore, after 10 months and 4 month after the interventionLDL-C will be assessed thanks to a fasting blood sample taken by a specialized nurse.
change in FMBefore, after 10 months and 4 month after the interventionFat mass (FM) was assessed using DXA following standardized procedures
Acylated Ghrelin concentrationBefore, after 10 months and 4 month after the interventionAcylated Ghrelin concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse
Leptin concentrationBefore, after 10 months and 4 month after the interventionLeptin concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse
Sleep metabolismBefore, after 10 months and 4 month after the interventionsleep duration will be assessed during an overnight polysomnography.
appetite feelingsBefore, after 10 months and 4 month after the interventionhunger satiety will be assessed using visual analogue scale at regular interval through a test day
Quality of life ScoreBefore, after 10 months and 4 month after the interventionA 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 PerceptionBefore, after 10 months and 4 month after the interventionA 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.
Triglycerides concentrationBefore, after 10 months and 4 month after the interventionTriglycerides concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse.

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026