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Pediatric ObesityIDEFIXNCT03466359

Energy Intake and Energy Deficit in Obese Adolescents

A study testing DEF-EI : Energy restriction induced energy deficit and DEF-EX : Exercise induced energy deficit in people with Pediatric Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 16 years
Conditions the study is for
Pediatric Obesity
What is being tested?
DEF-EI : Energy restriction induced energy deficit and DEF-EX : Exercise induced energy deficit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFrance
Study dates
8 Jan 2018to Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • Previous surgical interventions that is considered as non-compatible with the study.
  • Diabetes
  • weight loss during the last 6 months
  • cardiovascular disease or risks

Trial locations and contacts

1 site in 1 country.

Patrick LACARIN contact

04 73 75 11 95

placarin@chu-clermontferrand.fr

France1 site, 1 recruiting

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

    Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr

    Yves BOIRIE

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
DEF-EI : Energy restriction induced energy deficit, DEF-EX : Exercise induced energy deficit
Keywords
appetite control, obesity, Adolescents, Physical activity
Medical subject headings
Pediatric Obesity, Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DEF-EI : Energy restriction induced energy deficitBehavioural

    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 deficitBehavioural

    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.

Study groups in NCT03466359
Study groupRoleWhat they receive
DEF-EIExperimentalthese adolescents will follow a dietary restriction of 10% of their daily energy intake.
Receives: Behavioral: DEF-EI : Energy restriction induced energy deficit
DEF-EXExperimentalthese adolescents will increase their physical activity-induced energy expenditure by 10% per day.
Receives: Behavioral: DEF-EX : Exercise induced energy deficit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Before, after 10 months and 4 month after the intervention

Secondary outcomes (14)

  1. change in FM

    Fat mass (FM) was assessed using DXA following standardized procedures

    Measured: Before, after 10 months and 4 month after the intervention

  2. 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.

    Measured: Before, after 10 months and 4 month after the intervention

  3. Insulin concentration

    : Insulin will be assessed thanks to a fasting blood sample taken by a specialized nurse.

    Measured: Before, after 10 months and 4 month after the intervention

  4. Glycaemia concentration

    glycaemia, will be assessed thanks to a fasting blood sample taken by a specialized nurse.

    Measured: Before, after 10 months and 4 month after the intervention

  5. total cholesterol concentration

    cholesterol total will be assessed thanks to a fasting blood sample taken by a specialized nurse.

    Measured: Before, after 10 months and 4 month after the intervention.

  6. HDL-C concentration

    HDL-C will be assessed thanks to a fasting blood sample taken by a specialized nurse

    Measured: Before, after 10 months and 4 month after the intervention

  7. LDL-C concentration

    LDL-C will be assessed thanks to a fasting blood sample taken by a specialized nurse.

    Measured: Before, after 10 months and 4 month after the intervention

  8. Triglycerides concentration

    Triglycerides concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse.

    Measured: Before, after 10 months and 4 month after the intervention

  9. Acylated Ghrelin concentration

    Acylated Ghrelin concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse

    Measured: Before, after 10 months and 4 month after the intervention

  10. Leptin concentration

    Leptin concentration will be assessed thanks to a fasting blood sample taken by a specialized nurse

    Measured: Before, after 10 months and 4 month after the intervention

  11. Sleep metabolism

    sleep duration will be assessed during an overnight polysomnography.

    Measured: Before, after 10 months and 4 month after the intervention

  12. appetite feelings

    hunger satiety will be assessed using visual analogue scale at regular interval through a test day

    Measured: Before, after 10 months and 4 month after the intervention

  13. 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

    Measured: Before, after 10 months and 4 month after the intervention

  14. 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.

    Measured: Before, after 10 months and 4 month after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2018
  2. Study start8 Jan 2018
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03466359
Sponsor's protocol ID
CHU-378
Other IDs
2017-A00817-46
Acronym
IDEFIX
Status last verified
Mar 2018
First submitted
8 Feb 2018
Last updated
15 Mar 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32008915

Questions about this trial

What is this clinical trial studying?

A study testing DEF-EI : Energy restriction induced energy deficit and DEF-EX : Exercise induced energy deficit in people with Pediatric Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in energy intake at lunch time (time frame: Before, after 10 months and 4 month after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03466359, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.

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