NCT04902001

Brief Summary

While interdisciplinary weight loss intervention have been shown successful among adolescents with obesity, a weight regain is most of the time observed within the following weeks or months. The aim of the present project will be to better identify the independent role played by both the metabolic and mechanical load and their modification during weight loss, on the energy expenditure and energy metabolism of adolescents with obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 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

May 3, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 20, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2022

Completed
Last Updated

June 3, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

May 3, 2021

Last Update Submit

June 2, 2022

Conditions

Keywords

energy expenditureweight lossobesityadolescents

Outcome Measures

Primary Outcomes (1)

  • Change in Energy Expenditure between before and after weight loss

    amount of energy expended during the walking tests, measured using indirect calorimetry

    before and after the 12-week weight loss

Secondary Outcomes (5)

  • change in lipid oxidation between before and after weight loss

    before and after the 12-week weight loss

  • change in Fat mass between before and after weight loss

    before and after the 12-week weight loss

  • change physical activity preferences between before and after weight loss

    before and after the 12-week weight loss intervention

  • Change in Energy Expenditure between the unloaded and loaded walking test

    after the 12_week weight loss

  • Change in lipid oxidation between the unloaded and loaded walking test

    after the 12_week weight loss

Study Arms (1)

Adolescents with obesity

EXPERIMENTAL

Adolescents with obesity aged 12-16 years old

Behavioral: Multidisciplinary weight loss

Interventions

The adolescents will follow a 12-week intervention combining nutritional education, physical activity 3 times per week and psychological supports.

Adolescents with obesity

Eligibility Criteria

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

You may qualify if:

  • being aged 12-16 years old
  • no contraindication to physical exercise
  • no cardiovascular disease
  • BMI above the 97th percentile
  • candidate to a weight loss intervention

You may not qualify if:

  • surgery and medical conditions preventing them to perform the intervention
  • Weight loss during the previous 6 months
  • medication that could interfere with energy metabolism.
  • pregnancy
  • regular tobacco and alcool use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Pediatric ObesityWeight LossObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Yves Boirie

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
There is no need for masking here.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: One group of adolescents with obesity
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 26, 2021

Study Start

August 20, 2021

Primary Completion

April 25, 2022

Study Completion

April 25, 2022

Last Updated

June 3, 2022

Record last verified: 2022-06

Locations