- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02417909
Overweight, Quality of Life and Psychological Difficulties in Teenagers (QOL-ADOB)
Quality of Life and Psychological Difficulties in Relation With the Weight of Teenagers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There are two groups in this study : healthy volunteers and teenagers suffering from obesity.
Patients and healthy volunteers will come to the nutrition clinic center Naturalpha where the patient will complete a questionnaire. The included patients will also complete a questionnaire privately (without the presence of the parents), they will also be weighted and measured.
No further tests or questionnaires will be given after the enrollment day.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria for obese teenagers :
- 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
Inclusion Criteria for average weighted teenagers :
- 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
Exclusion Criteria for obese children :
- Body Mass Index over the 97th percentile curve on the corpulence curves of the PNNS
- Handicapped teenagers
Exclusion Criteria for average weighted children :
- 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
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
all teenagers included in the trial and their parents must complete the questionnaires given of them the day of enrollment.
|
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.
|
all teenagers included in the trial and their parents must complete the questionnaires given of them the day of enrollment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the quality of life of obese and average weighted teenagers
Time Frame: day of enrollment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare psychopathologic symptoms (depression, anxiety and social anxiety) in both populations
Time Frame: day of enrollement
|
Patients are asked to complete quality of life questionnaires.
The parents are also asked to complete a questionnaire.
|
day of enrollement
|
Compare the satisfaction of the needs described in the theory of auto-determination in both populations
Time Frame: day fo enrollment
|
Patients are asked to complete quality of life questionnaires.
The parents are also asked to complete a questionnaire.
|
day fo enrollment
|
Explore the link between endured stigmatisation and self esteem for obese teenagers
Time Frame: day of enrollment
|
Patients are asked to complete quality of life questionnaires.
The parents are also asked to complete a questionnaire.
|
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.
Time Frame: day of enrollment
|
Patients are asked to complete quality of life questionnaires.
The parents are also asked to complete a questionnaire.
|
day of enrollment
|
Explore the possible links between the measured concepts
Time Frame: day of enrollment
|
Patients are asked to complete quality of life questionnaires.
The parents are also asked to complete a questionnaire.
These questionnaires will then be analysed in order to check for possible links between the secondary outcome measures wirtten above.
|
day of enrollment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gronnier Pascale, MD, Groupment des Hôpitaux de l'Institut Catholique de Lille
- Principal Investigator: Gueorguieva Iva, MD, Centre Hospitalier Universitaire de Lille
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RC-P0011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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