NCT02417909

Brief Summary

Obesity is a major public heath issue. It may have various impacts on a patient's life by causing psychological problems, altering a patient's quality of life,etc. These led to the investigators' hypothesis which is examining the psychological dimensions of a teenager suffering for obesity.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

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

Study Start

First participant enrolled

July 1, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 5, 2015

Status Verified

May 1, 2015

Enrollment Period

3.5 years

First QC Date

April 13, 2015

Last Update Submit

August 4, 2015

Conditions

Keywords

Obesityquality of lifeteenagerspsychological impact

Outcome Measures

Primary Outcomes (1)

  • Compare the quality of life of obese and average weighted teenagers

    patients are weighted, measured and are asked to complete quality of life questionnaires. The parents are also asked to complete a questionnaire. The questionnaires answered by the teenagers are KIDSCREEN; CES-D; STAI-C; PJNA; EPADV; EPCDV and EQRI, they will be analysed along with the questionnaires completed by the parents, inorder to compare the quality of life of obese and average weighted teenagers.

    day of enrollment

Secondary Outcomes (5)

  • Compare psychopathologic symptoms (depression, anxiety and social anxiety) in both populations

    day of enrollement

  • Compare the satisfaction of the needs described in the theory of auto-determination in both populations

    day fo enrollment

  • Explore the link between endured stigmatisation and self esteem for obese teenagers

    day of enrollment

  • Explore the effect of the support of the needs described in the auto-determination theory and their link to endured stigmatisation, quality of life and self esteem, for obese teenagers.

    day of enrollment

  • Explore the possible links between the measured concepts

    day of enrollment

Study Arms (2)

Healthy volunteers

This group is composed of healthy teenagers that volunteered to participate in the trial and that will answer questionnaires about quality of life. Parents will anwser questionnaires too.

Other: questionnaires about quality of life

Obese teenagers

This group is composed of obese teenagers that have been recruited to participate in the trial and that will answer different questionnaires quality of life. Parents will anwser questionnaires too.

Other: questionnaires about quality of life

Interventions

all teenagers included in the trial and their parents must complete the questionnaires given of them the day of enrollment.

Healthy volunteersObese teenagers

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Two categories of teenagers will be included : obese teenagers and average weighted volonteers

You may qualify if:

  • Patients aged between 11 and 16 years old at the moment of enrollment.
  • Body Mass Index between the 1st and 2nd degree of the obesity zone (over the 97th percentile curve regarding corpulence curves of the Plan National Nutrition Santé (PNNS) based on the gender (boys/girls))
  • The teenagers have an appointment in the pediatric unit of the Saint Vincent de Paul Hospital for an examination regarding excess weight
  • Patients aged between 11 and 16 years old at the moment of enrollment
  • Body Mass Index located between the 3rd and the 97th percentile on the corpulence curves of the PNNS
  • The teenagers and their parents have replied to and advertisement of the trial

You may not qualify if:

  • Body Mass Index over the 97th percentile curve on the corpulence curves of the PNNS
  • Handicapped teenagers
  • Body Mass Index over the 97th percentile curve or under the 3rd percentile curve on the corpulence curves of the PNNS
  • Handicapped, asthmatic, obese or diabetic teenagers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gronnier Pascale, MD

    Groupment des Hôpitaux de l'Institut Catholique de Lille

    PRINCIPAL INVESTIGATOR
  • Gueorguieva Iva, MD

    Centre Hospitalier Universitaire de Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 16, 2015

Study Start

July 1, 2011

Primary Completion

January 1, 2015

Study Completion

July 1, 2015

Last Updated

August 5, 2015

Record last verified: 2015-05