NCT03967782

Brief Summary

The aim of the present study is to compare the effect of realizing an exercise right before or right after a meal of on energy intake, appetite feelings and food reward in adolescents with obesity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 31, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

June 11, 2020

Status Verified

October 1, 2019

Enrollment Period

29 days

First QC Date

May 27, 2019

Last Update Submit

June 9, 2020

Conditions

Pediatric obésity

Keywords

appetite controlobesityadolescentsexercise timing

Outcome Measures

Primary Outcomes (1)

  • Change in energy intake measured during an ad libitum buffet meal (in kcal)

    food intake will be measured ad libitum during a lunch buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be weighted using an electronic food scale by a member of the investigation team and then analysed using Bilnuts software.

    day 1 , day 8, day 15

Secondary Outcomes (2)

  • Hunger feelings

    day 1 , day 8, day 15

  • Food reward

    day 1 , day 8, day 15

Study Arms (1)

cohorte 1

EXPERIMENTAL

18 adolescents with obesity are involved and will perform the three conditions.

Behavioral: CONBehavioral: EX-MEALBehavioral: MEAL-EX

Interventions

CONBEHAVIORAL

Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.

Also known as: control condition without exercise / rest condition
cohorte 1
EX-MEALBEHAVIORAL

Condition with an acute exercise set right before lunch The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) right before ad ad libitum lunch meal. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.

Also known as: Condition with an acute exercise set right before lunch
cohorte 1
MEAL-EXBEHAVIORAL

. condition with an acute exercise set right after lunch. The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) right after an ad libitul buffet meal. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.

Also known as: Condition with an acute exercise set right after lunch
cohorte 1

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (2)

  • Moore H, Pereira B, Fillon A, Miguet M, Masurier J, Beaulieu K, Finlayson G, Thivel D. The association between obesity severity and food reward in adolescents with obesity: a one-stage individual participant data meta-analysis. Eur J Nutr. 2024 Jun;63(4):1241-1255. doi: 10.1007/s00394-024-03348-4. Epub 2024 Feb 20.

    PMID: 38376518DERIVED

  • Fillon A, Beaulieu K, Miguet M, Bailly M, Finlayson G, Julian V, Masurier J, Mathieu ME, Pereira B, Duclos M, Boirie Y, Thivel D. Does exercising before or after a meal affect energy balance in adolescents with obesity? Nutr Metab Cardiovasc Dis. 2020 Jun 25;30(7):1196-1200. doi: 10.1016/j.numecd.2020.04.015. Epub 2020 Apr 23.

    PMID: 32482455DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • yves Boirie

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2019

First Posted

May 30, 2019

Study Start

August 31, 2019

Primary Completion

September 29, 2019

Study Completion

October 30, 2019

Last Updated

June 11, 2020

Record last verified: 2019-10

Locations

FR(1)