Overweight, Quality of Life and Psychological Difficulties in Teenagers (QOL-ADOB)

August 4, 2015 updated by: Lille Catholic University

Quality of Life and Psychological Difficulties in Relation With the Weight of Teenagers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
173

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Other: questionnaires about quality of life
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lille Catholic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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