NCT04734639

Brief Summary

The aim of the present study is to compare the effect of iso-energetic energy deficits induced by energy restriction alone or exercise + dietary restriction (Mixed deficit) on energy intake and appetite feelings 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 Apr 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 24, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

January 27, 2021

Last Update Submit

September 30, 2021

Conditions

Pediatric Obesity

Keywords

appetite controlobesityAdolescentsexerciseEnergy Deficit

Outcome Measures

Primary Outcomes (1)

  • Change from different intervention of energy intake measured during an ad libitum buffet meal (in kcal).

    food intake will be measured ad libitum during a dinner 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)

Obese adolescents

EXPERIMENTAL

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

Behavioral: CON . control condition without exercise / rest conditionBehavioral: Def-Mixed. Condition with a mixed energy deficit induced by exercise + dietary restriction.Behavioral: Def-EI. Condition with an energy-restriction energy deficit

Interventions

CON . control condition without exercise / rest conditionBEHAVIORAL

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 dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.

Obese adolescents
Def-Mixed. Condition with a mixed energy deficit induced by exercise + dietary restriction.BEHAVIORAL

Def-Mixed. Condition with an exercise-induced energy deficit The adolescents will received a calibrated lundh meal with a deduction of 250 kcal compared with the lunch meal of Con; and will be asked to realise an acute exercise set at 65% of their capacities (cycling) during the afternoon, inducing an energy expenditure of 250 kcal. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.

Obese adolescents
Def-EI. Condition with an energy-restriction energy deficitBEHAVIORAL

Condition with an energy-restriction energy deficit The adolescents will receive a calibrated breakfast reduced from 500 kcal compare to their CON and Def-mixed conditions. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.

Obese adolescents

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
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

MeSH Terms

Conditions

Pediatric ObesityObesityMotor Activity

Interventions

ExerciseDiet Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutrition TherapyTherapeutics

Study Officials

  • Valérie JULIAN

    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

January 27, 2021

First Posted

February 2, 2021

Study Start

April 24, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

October 1, 2021

Record last verified: 2021-09

Locations

FR(1)